Patirnt
Education
Elsevier Scientific
and Counseling,
Publishers
19 ( 1992) 61-74
Ireland
61
Ltd.
Improving Self-Care Among Older Patients with Type II Diabetes: The “Sixty Something...” Study Russell E. Glasgow, PhD”, Deborah J. Toobert, PhD”, Sarah E. Hampson, PhD”, Jane E. Brown, BAa, Peter M. Lewinsohn, PhD” and Jodie Donnelly, RDb “Oregon
Research Institute.
IX99
Willamette
Street
Eugene,
OR 97401 und ‘Nutrition
Assoc~crte.v. .?.?.( Mill
Street.
Eu~cwv
OR 97401
(USA1
(Received
April 26th.
(Accepted
October
1991)
11th. 1991)
Abstract A IO-session, self-management
training program
was designed specifically for persons of age having learning
Type II diabetes.
variables, especially problem-solving
and self-efficacy, se&are
over 60 years
It targeted
found
to be related
in earlier correlational
skil1.s
to diabetes
research.
dred two adults were randomized
social
One hun-
to immediate
or
delayed intervention conditions. At posttest, subjects in the
immediate
intervention
significantly greater reductions percent The
of calories from fat
intervention
also
condition
showed
in caloric intake and
than control subjects.
produced
greater
reductions and increases in the frequency
weight
of glucose
testing than did the control condition. Improvements among immediate
intervention
subjects were gener-
ally maintained at a 6-month follow-up.
Intervention
results ,from subjects receiving
delayed
intervention
those for immediate
intervention
closely replicated subjects.
We conclude
program
can
improve
that a relatively
short-term
self-management
skills
of
older diabetic adults, and that there is an important need for such interventions.
Keywords:
Self-care; Diabetes Problem-solving; Older patients.
education;
Introduction
There have been numerous diabetes educa0738-3991/92/$05.00
Printed
and Published
1992 Elsevier Scientific in Ireland
0
Publishers
Ireland
tion studies, many of which have been summarized in recent reviews and meta-analyses [l-3]. However, relatively few studies are randomized trials or otherwise well controlled, and they tend to produce improvements in diabetes knowledge but less on measures of behavior change [l]. Few studies have improvement in patient self-care behaviors as their primary goal. Somewhat separate literatures evaluate interventions to improve dietary behavior [4,5], exercise [6], and glucose testing [7,8] but very few studies address all three self-care endpoints. There is a particular need for research on self-care programs for older diabetic patients. A large and increasing percentage of the population with diabetes is over 65 years of age [9,10]. Recent research suggests that the prevalence of diabetes is almost 10% among persons age 65 and older [9], and that these patients suffer a disproportionate amount of disease burden because it is often later in life that complications from diabetes appear. Older patients typically have received less diabetes education than their younger counterparts and often experience many more barriers to medical care [ 1I]. Unfortunately, there are very few studies of ways to improve diabetes self-care among older patients. The majority of diabetes education studies focus Ltd
62
on newly diagnosed patients, in particular, on adolescents and young adults with Type I diabetes. The present study describes and evaluates a program to improve diabetes self-care developed specifically for persons with Type II diabetes who are over 60 years of age. The intervention was based upon results from our previous research on psychosocial predictors of diabetes self-care behaviors [ 12,131. In addition, focus groups and evaluation interviews with older Type II patients were conducted to identify particular areas for intervention and barriers to self-care. Our approach was to develop an intervention that would be responsive to the needs of older persons, and would cognitive behavioral processes enhance previously found to prospectively predict selfcare such as self-efficacy and problem solving skills. This intervention was then evaluated in an initial randomized trial that included multiple measures of treatment outcome, a 6-month follow-up, and a quasi-experimental replication of intervention effectiveness. Method Design and procedures
A heterogenous group of outpatients who were 60 or more years of age and had Type II diabetes was recruited using a variety of methods described below. Patients meeting the inclusion criteria and wishing to participate were invited to attend one of several orientabaseline tion sessions. Those completing assessment were blocked on type of diabetes medication (insulin, oral medication or no diabetes medication) and then randomly assigned to either immediate or delayed intervention conditions. Following a 3-month interval during which Immediate Intervention subjects received the program, a second assessment session was held. After this posttest assessment, subjects in the Delayed Intervention condition received the intervention. Subjects in the Immediate Intervention condition received 6-month follow-up assessments to
evaluate the longer term effects of the program. Those in the Delayed Intervention condition were reassessed after completing the intervention to provide a quasi-experimental replication of the effects of intervention. Recruitment
Several steps were taken during the planning stage to enhance the appeal of the program to older adults. To overcome financial barriers, the program was offered free of charge and participants were provided glucose testing materials and a coupon for a pair of walking shoes. Both weekly meetings and exercise sessions were held during daylight hours in well-known, accessible, and pleasant facilities that earlier focus group participants had indicated would be most convenient. The “Sixty Something...” program was promoted extensively among local diabetes care professionals (e.g., internists and endocrinologists, diabetes educators, staff of local diabetes association) through presentations, mailings, and individual meetings prior to announcement to the general public. Patients of appropriate age under the care of physicians operating the three largest diabetes practices in the local area received a letter from their physician describing the project and encouraging participation. This was followed by a telephone call from project staff unless patients indicated they did not wish to be contacted. A similar letter and follow-up phone call procedure was employed with patients who previously participated in assessment research at Oregon Research Institute, as well as with members of the local diabetes association. Other recruitment activities involved notices and advertisements in a variety of media including the local newspaper (both classified and personal ads), newsletters of local and state diabetes associations, presentations at health fairs and other meetings, flyers distributed to major grocery stores and pharmacies, coverage on a local television program on community services, and public service announcements on the radio. More
63
detail on recruitment procedures and participation response rates are presented by Glasgow et al. [14]. Eligibility criteria for the program included being 60 years of age or older, being primarily responsible for one’s own self-care (institutionalized patients were not eligible), meeting the Welborn et al. [IS] clinical criteria for Type II diabetes, and not having major complications which would interfere with self-care (e.g., legally blind, severe stroke, on kidney dialysis). Subjects meeting these eligibility criteria were required to obtain their physician’s permission to participate and to pass a submaximal graded exercise test conducted at the University of Oregon Slocum Sports Medicine Laboratory. This exercise test was provided at no charge to participants. Subjects A total of 102 persons completed baseline assessment and were randomized into the study. Table 1 summarizes the characteristics of these subjects. As can be seen, there were no differences between conditions on these variables. The average age was 67 with 23% of participants over 70 years of age. As would be expected in this age group, there were more females than males participating. About onequarter of the participants were treated with insulin and another half were on oral medication for diabetes. Most patients had lived with their diabetes for a number of years and 88% also had other chronic diseases, the most common being arthritis and hypertension (both affecting 44% of subjects). Intervention The “Sixty Something...” program focused primarily on dietary and exercise self-care behaviors, and also included regular blood glucose monitoring with the Ames Glucometer Memory Meter. The reason for this focus was that our previous research has found that the lifestyle behaviors of diet and exercise are less well adhered to than more medical aspects of the diabetes regimen such
Table 1. Characteristics of participants: mean (and SD) or percent of patients by intervention condition.
Patient characteristic
lmmediate intervention (n = 52)
Delayed intervention (n = 50)
Age
67.1 (4.3)
67.2 (5.8)
Percent female
63.5
62.0
Diabetes medication (‘%I) Insulin 26.9 Oral medication 46.2 26.9 Diet only
26.0 50.0 24.0
Comorbidity (‘%I) No other diseases l-2 other diseases ~3 other diseases Diabetes history Years diagnosed Years with current physician ‘%previously attended diabetes education
II.5
12.0
34.6 53.8
38.0
9.4 (9.2) 4.7 (5.3)
50
50.0
9.5 (8.1) 5.8 (7.4)
44
[ 16,171. Also, particias taking medication pants in focus groups had rated diet and exercise as the areas in which they could most use assistance. Specific dietary targets included reducing caloric intake, decreasing consumption of fats, and increasing dietary fiber intake. For exercise, the goal was regular participation in low level aerobic activity, which for most participants involved walking or stationary bicycling. Individual goals for gradual improvement were set for each participant in the immediate intervention condition, based upon baseline levels of dietary intake and performance on the graded exercise test.
The program was led by an interdisciplinary team including psychologists, a American College of registered dietitian, Sports Medicine certified exercise leaders, and other educators. Group meetings of six to
64
twelve participants were held and the emphasis was on developing individualized plans to overcome barriers to adherence. The program focused on problem-solving, and participants were provided with example barriers and coping strategies identified from our previous research. Table 2 summarizes the content of each of the 10 sessions. Meetings followed a sequence of discussing the assignment from the previous week and sharing progress, followed by an informational presentation on a new topic (e.g., reducing dietary fat, increasing exercise, planning ahead for maintenance), and concluded with each participant completing a personalized goal-setting and coping strategy worksheet for the coming week. Groups met weekly for 8 weeks with all participants working on similar goals (e.g., decreasing caloric intake, increasing fiber consumption), followed by two meetings held at 2-week intervals during which participants chose the specific self-care area on which they wished to focus. Twice weekly group exercise (walking) sessions led by a trained exercise leader were held during the middle 8 weeks of the program. In addition, participants were
Table 2. “Sixty Session 1 2 3 4 5 6 7 8 (2 weeks) 9 (2 weeks) 10
Something...ORI
Primary
Diabetes Self-Care
review
Blood glucose monitoring
encouraged to exercise at least one additional time per week on their own. Participants were encouraged to share strategies and problem solutions with each other. The fifth and sixth sessions focused on increasing pleasant events, particularly those involving social interaction, and social interaction was encouraged during the walking sessions. The final two sessions focused on maintenance and relapse prevention. Information was presented on situations with high risk for developed inrelapse, and participants dividualized plans for coping with personal high-risk situations. Measures
A variety of measures were collected to evaluate the impact of the intervention on different outcomes and to identify the processes through which the intervention worked. Self-care outcomes. Multiple measures were collected of each of the targeted dietary and exercise self-care behaviors. Measures of average daily caloric intake, average percent of calories from fat, and average grams of dietary fiber per day were assessed using two procedures. First, participants completed the
Education Program”: outline of sessions. Main discussion
topic
Log of exercise activities Fat reduction goals Log of exercise activities Calorie reduction goals Mood and pleasant activity log Report on eating out assignment Fiber consumption goals
Exercise-basic concepts, foot care and safety, personal fitness profiles Decreasing fat consumption Exercise-integrating into daily activities Decreasing calories consumed Mood and pleasant events Social activities, eating out Increasing dietary fiber Personal goals
Goal attainment
Relapse Wrap-up
prevention,
coping with holidays
and assessments
In addition to the above, participants took part in supervised exercise (walking) sessions twice per week and were asked to exercise one other time per week using the buddy system.
65
dietary history portion of the Block/NC1 Health Habits and History Questionnaire [18]. Data were analyzed using software provided by the National Cancer Institute. In addition, participants were instructed in procedures for completing a 3-day food record and kept such a record for three consecutive days consisting of two weekdays and one weekend day. Participants received instructions about commonly omitted foods and a sample food record prior to beginning their food records. Completed records were reviewed with subjects, using food models and household measuring devices to clarify amounts consumed, and analyzed using the Food Processor II Nutrition and Dietary Analysis system [ 191. Average daily intake scores on each of the three dietary target behaviors from the diet history and food records were used for the analyses reported below. Physical activity was assessed using the Stanford 7-Day Recall [20]. This measure consists of an interview of participants about the amount of time spent in each of three levels of activity and is scored to produce a final measure of average kilocalories expended per day*. In addition, individualized goals were set for each participant in the Immediate Intervention condition based upon their baseline levels of dietary and exercise self-care. For diet, the daily caloric intake needed to maintain body weight was calculated for the participant’s age, gender, height and weight [21]. We then subtracted 500-800 calories from this figure to establish a caloric intake goal to be not less than 1500 calories/day for men and 1000 for women. Based upon this figure, a goal for grams of fat per day was set so that fat intake did not exceed 30% of this caloric target. For fiber the goal was to gradually increase dietary fiber up to a level of 30 g/day. For exercise, a goal of exercising at a *Due IO budgetary constraints, it was not possible post-intervention assessments of physical fitness.
to conduct
moderate aerobic level (65-75X of maximum heart rate) 4 days per week was established. Comparable goals were established (but not communicated) for Delayed Intervention subjects from their baseline data so that conditions could be assessed on comparable measures of goal attainment. Frequency of glucose testing was assessed using data that were directly uploaded from the subjects’ Glucometer M Memory meter to our computer. Other outcome measures. Glycosylated hemoglobin was measured using the BioRad A,, micro column method [22]. Normal values using this assay are from 4.2 to 5.9%. Weight was assessed in stocking feet using a Detect0 medical office scale. The other biological measure collected was average fasting blood glucose level. These data were obtained from the memory meter device built into the Glucometer M blood glucose monitoring machine. Impact of treatment on diabetes related quality of life was assessed via a modification of the DCCT Quality of Life Scale [23]. Twenty items from the impact subscale which were relevant to NIDDM were administered to produce a total score. Process measures. Several measures were collected to assess the processes through which the intervention was hypothesized to operate. Diabetes specific self-efficacy [24] was assessed using a measure that we have found to be consistently related to diabetes self-care [ 13,251.
Mood was assessed using two instruments: the Pleasant Events Schedule for Older Persons [26] and the Geriatric Depression Scale [27]. Both of these instruments have been validated and used extensively with older subjects. To determine the impact that social desirability might have on the self-report measures, we included the Balanced Inventory of Desirable Responding [28] which was covaried out from outcome scores on these variables.
66
Finally, problem-solving was assessed using a procedure that we have previously developed and found to be related to diabetes self-care [29]. Nine different scenarios were described and subjects were asked how they would respond to each situation. Using a standardized procedure, subjects were prompted for additional solutions. Responses were tape recorded and scored by coders to produce two summary scores: an average overall rating of problem-solving skill and the number of different solutions proposed. Interrater reliabilities on these summary scores for a randomly selected 25% of subjects revealed correlations ranging from 0.77 to 0.99 at the different assessment points, with an average of 0.89. Although the tape recorded interactions were not identified by treatment condition, in some cases the raters were aware of a given subject’s group assignment. However, given the objective nature of the scoring system and the relatively high interrater reliabilities, it is unlikely that knowledge of treatment condition affected the outcome of these summary scores. Results
Data were analyzed using the SPSS” statistical package. We first present data on baseline comparability of conditions on dependent variables, followed by information on subject attrition. Outcome results are then presented for targeted behavioral outcomes, and process measures. other endpoints, t-tests were used to Paired comparison evaluate change over time within each of the experimental conditions. For each of these sets of measures, analyses of covariance were then used to compare treatment conditions, covarying out the effects of pretest scores on posttest results. Additional analyses were also conducted on all self-report measures that covaried out the effects of social desirability. In every case the
conclusion from the analyses were the same as when using unadjusted scores. As can be seen in Table 3, the two conditions were very similar at baseline on almost all of the dependent variables. There were significant baseline differences on only one measure - average minutes of activity per day (F = 4.6, P < 0.05). There was very little subject attrition during the initial 10 week evaluation period. All 52 subjects in the Immediate Intervention condition and 49 of 50 subjects in the Delayed Intervention condition were assessed at posttest. By the time of the 6-month follow-up for the Immediate Intervention group, there was somewhat greater loss to follow-up: 48 or 92% of subjects were assessed at that point. Attendance during the program was also good, with participants attending 90% of self-care education sessions. Exercise sessions were not as well attended, with participants attending 60% of group exercise sessions on average. Targeted self-care behaviors
As can be seen in Table 3, the Immediate Intervention condition produced significantly greater posttest improvement on two of the three dietary targets than did Delayed Intervention. Data from food records indicated that intervention produced signilicant reductions in both overall caloric consumption and the percentage of calories from fat, while Delayed Intervention subjects did not change their fat intake and showed nonsignificant increases in caloric consumption. The Block Diet History Questionnaire produced calorie and fat intake results that were higher than those produced by the food records, but the pattern of changes was very similar to that observed on the food records. Between groups comparisons on the Block instrument were significant for percent of calories from fat, but not on caloric intake, despite a 200 kcal/day greater reduction in intake in the Immediate than Delayed Intervention condition. There were no significant within group changes or between condition differences on either measure of dietary fiber intake.
67
Table
3.
Self-care
Pretest,
posttest,
and follow-up
area
Mean calories per day 1. From Block/NC1 Immediate treatment Delayed treatment 2. From 3-day food record Immediate treatment Delayed treatment Mean percent of calories from fat I. From Block/NC1 Immediate treatment Delayed treatment 2. From 3-day food record Immediate treatment Delayed treatment Mean grams of fiber per day From Block/NC1 1. Immediate treatment Delayed treatment 2. From 3-day food record Immediate treatment Delayed treatment Mean number of days exercised Immediate treatment Delayed treatment
results
behaviors.
Pretest
Posttest
Follow-up/post
1979.9 (927.0) 2079.3 (1300.5)
1796.4 (702.0) 2083.3 (907.7)
1675.6’ (721.7) 1754.3 (777.5)
1631.6 (494.6) 1636.1 (412.5)
1468.2 (474.0)b.* 1686.0 (426.7)h
151 I .6 (432.7) 1413.5’ (355.7)
39.5 (8.9) 41.4 (8.5)
35.9 ( 7.6)h.’ 41.7 (8.0)h
37.0 (8.3) 36.4’ (7.5)
33.2 (7.2) 34.5 (8.1)
29.0 (6.7)‘.* 33.6 (6.0)h
29.6’ (8.5) 29.2’ (6. I)
19.3 (I 1.2) 20.8 (14.9)
21.0 (9.3) 19.6 (9.0)
17.6 (7.8) 20.1 (9.3)
20.9 (8.8) 19.9 (6.8)
21.7 (10.0) 21.0 (7.1)
20.4 (8.1) 22.0 (7.6)
4.4 (2.4) 3.7 (2.3)
4.5 (2.0) 3.7 (1.8)
3099.6 (762.2) 2900.0 (573.1)
Average minutes of activity per day Immediate treatment Delayed treatment
36.3 (5.2) 34.6 (2.1)
“Six-month bSignificant
self-care
Mean (and SD)
Mean energy expenditure by weight Immediate treatment Delayed treatment
?? Significant
on targeted
2997.8 (673.5) 2909.7 (557.6)
36.2 (3.2)h.* 34.5 (2.2)
TX”
4.4 (2.1) 4.6 (1.9)’
4227.8 (895.5)’ 2880.1 (615.3)
50.8 (4.7)’ 35.8 (4.6) _
improvement from pretest on this measure, follow-up for Immediate Treatment condition; posttreatment results for Delayed between treatment condition difference on analysis of covariance.
The improvements made by Immediate Intervention subjects in dietary behaviors were generally maintained at the 6-month followup. Reductions in both caloric consumption and fat intake were still significant on one of
Treatment
condition.
the two dietary instruments at this assessment and mean caloric intake from the Block instrument was (nonsignificantly) less than at posttest. Confidence in the replicability of these results is further increased by the
68
substantial reductions observed on these same variables among Delayed Intervention subjects when they received intervention (see Table 3). These reductions were equal to or greater than those observed among Immediate Intervention subjects and were observed on both food records and the Block instrument. Results on the individualized goal setting measures closely parallel those reported above for absolute levels of dietary self-care. A significantly higher proportion of Immediate Intervention than Delayed Intervention subjects had achieved these goals for caloric intake (29% versus IO%, P < 0.05) and fat consumption (45 versus 29%, P c 0.001) by posttest assessment. There were no significant intervention effects on personalized goals for fiber intake or days exercised. In contrast to the improvement shown on the targeted dietary measures, there was little short term effect on measures of exercise behavior. Posttest measures, collected 2 weeks following the conclusion of group exercise classes, showed neither significant changes
Table 4.
Results on generalization
Measure
from pretest levels nor between groups differences. By time of follow-up, however, subjects in the Immediate Intervention condition had substantially increased the average number of minutes of activity per day (see Table 3). Finally, data from the Glucometer M memory meter showed that subjects in the Immediate Intervention condition significantly increased the percent of days they tested their fasting blood glucose level compared to Delayed Intervention subjects. These improvements were not as well maintained as were other behavior changes, however. This may have been due at least in part to the fact that at follow-up, subjects were provided with many fewer strips than they had been at pretest and posttest. Other outcomes Table 4 presents results on other outcome measures. As can be seen, Immediate Intervention produced significant improvements compared to the Delayed Intervention condition, and to baseline, on weight. Glycosylated hemoglobin (GHb) levels significantly decreased for both Immediate Intervention
measures. Mean (and SD) Pretest
Posttest
Follow-up/replication”
188.0 (34.2) 184.5 (34.4)
182.2b,* (33.9) 185.9b (34.6)
186.1’ (32.6) 181.0’ (34.7)
6.8 (1.6) 7.4 (1.8)
6.3’ (1.5) 7.0 (1.5)
6.7 (1.7) 6.4’ (1.4)
Weight (in lb) Immediate intervention Delayed intervention
Glycosylated hemoglobin Immediate intervention Delayed intervention
Diabetes Quality of Life Scale 37.9 (8.8) 36.8 (8.0)
Immediate intervention Delayed intervention *Significant “Six-month dition. bSignilicant
improvement (P < 0.05) from pretest follow-up for Immediate Intervention between
treatment
condition
difference
38.1 (9.2) 37.2 (7.5)
38.2 (7.4) 36.3 (8.0) on this measure. condition; posttreatment on analysis
of covariance
results
for Delayed
at posttest.
Intervention
con-
69
Table Process
5.
Change
on process
measures.
measure
Mean (and SD) -_ Pretest
Problem-solving ability rating Immediate intervention Delayed intervention
Posttest
Follow-up/replication”
3.2 (0.5) 3.1 (0.5)
3.5h,* (0.4) 3.2h (0.5)
3.7* (0.6) 3.6* (0.6)
Number of problem-solving strategies used Immediate intervention 9.3 (2.6) Delayed intervention 8.8 (2.6)
10.5h,* (2.3) x.9h (2.9)
10.8’ (3.5) 10.6’ (2.6)
Self-efficacy: diet Immediate intervention Delayed intervention
81.2 (19.2) 85.5 (19.6)
78.7 (22.8) 79.1 (27.4)
74.9 (28.6) 77.2 (29.3)
Self-efftcacy: exercise Immediate intervention Delayed intervention
68.3 (26.3) 70.3 (24.5)
64.3 (31.8) 68.2 (27.7)
60.2 (33.9) 66.2 (31.2)
improvement (P < 0.05) from pretest follow-up for Immediate Intervention
on this measure. condition; posttreatment
-_ ‘Significant “Six-month dition. hSignificant
between
treatment
condition
difference
on analysis
and Delayed Intervention subjects, but there were no significant between groups differences. Although the magnitude of these changes was not large (6 lb weight loss and 0.5% on glycosylated hemoglobin), these changes were about what reasonably could be expected from a behavioral program of this intensity. There were few increases or decreases in medication over the course of the study, and no between groups differences on medication changes. Analyses of covariance at posttest on GHb for the subset of subjects not experiencing changes in the type of medication they were prescribed revealed a marginally significant effect in favor of intervention (F = 3.23, df = 1,90, P < 0.08). Supplemental analyses revealed that GHb reductions were larger among Immediate Intervention subjects not taking insulin than among those on insulin (0.7 versus 0.3%) and that the between groups intervention effects were marginally significant for noninsulin taking subjects (F = 3.56, df = 1,71, P < 0.06).
of covariance
results
for Delayed
Intervention
con-
at posttest.
Six-month follow-up results were generally encouraging. Subjects in the Immediate Intervention condition still weighed signiticantly less than at pretest (P < 0.002), and they had kept off most of the weight they had initially lost (4.5 lb of the initial 6 lb loss for subjects available at follow-up). Further support for the validity of the findings for the weight and glycosylated hemoglobin measures comes from the replication involving treated subjects in the Delayed Intervention condition. After receiving intervention, these subjects showed significant weight losses (5 lb) and reduction in GHb (0.6”%), both of which were very similar to reductions shown by Immediate Intervention subjects. Correlations between changes on behavioral measures and changes in physiological measures were modest, complex and somewhat inconsistent. The only statistically significant associations were between reductions in percent of calories from fat on the food
70
records (but not the Block questionnaire) and weight loss (Y k 0.33, P < O.Ol), and between changes in number of glucose tests per day and weight loss (r = -0.21, P < 0.05). There were no significant quality of life measure.
effects on the
Process measures
There were consistent and relatively large improvements associated with intervention on measures of problem solving. The Immediate Intervention group showed significant improvement at posttest in both measures of problem solving, the overall ability rating and the number of different strategies used. These increases were significantly greater than those in the Delayed Intervention condition (see Table 5). results on problem-solving Follow-up measures were even more encouraging. Subjects in the Immediate Intervention condition continued to improve on both measures over the follow-up interval. In addition, subjects in the Delayed Intervention condition showed significant improvement on both problemsolving measures following their treatment. These improvements were of approximately the same magnitude as those shown earlier by the Immediate Intervention condition, providing a replication of intervention effectiveness in improving problem solving. In contrast, there were no significant improvements on self-efficacy or mood Ievel. In the case of the self-efficacy measures, this may have been due partially to ceiling effects produced by high pretest scores on these measures (e.g., for dietary efficacy, 50% of subjects had pretest efficacy scores of 90 or higher on the IOO-point scale). Discussion
The “Sixty Something. ..” program was generally effective in producing behavior change on the measures of dietary intake and glucose testing behavior targeted for intervention. Confidence in the robustness of the di-
etary outcomes is enhanced by the similar pattern of results across two different assessment methods, food records and a sophisticated diet history measure. The Block/NC1 procedure gave higher absolute levels of both calories and percent of calories from fat, possibly suggesting that the food recording process may have been reactive. However, the most important findings were the consistency in the pattern of changes between conditions and over time. Both measures indicated substantial reductions in both calories and fats in the immediate Intervention condition (which were generally maintained over time), while the delayed condition showed few changes on either measure until intervention. The fact that the reductions in caloric intake and consumption of fats remained significant at follow-up and after adjusting for tendencies to give socially desirable responses further increases confidence in these results, as does the replication of these intervention effects observed when Delayed Intervention subjects received intervention. It is less clear why there were not corresponding significant increases in dietary fiber intake associated with treatment. One possibility is that subjects were already closer to recommended levels of fiber intake at baseline (20 g/day) than they were for caloric or fat intake. Average baseline dietary fiber intake of 20 g/day exceeded the national average of lo-12 g for white adults over 55 years of age [30] but baseline average percent of calories from fat (37%) was close to the national norm. Alternatively, it may be that fiber is a less familiar concept to subjects, which is less reinforced by the media and environment than reductions in either calories or fat intake, and consequently harder to change. A third possibility is that the fiber intervention came toward the end of the program and it may have been difficult for participants to make additional dietary changes. The two physical activity measures showed somewhat different patterns of results. Treat-
71
ment subjects were already fairly active in terms of number of days exercised per week at baseline (almost 4.5) and it may not have been realistic to expect further increases. Such an explanation would be consistent with the significant improvement to this 4.5 days per week level following treatment shown by Delayed Intervention subjects, who were exercising less frequently at baseline (see Table 3). It is more difficult to explain why there was not short-term improvement in number of minutes exercised per day. Also, there appeared to be a delayed effect of intervention in which Immediate Intervention subjects demonstrated a significant increase in minutes exercised at follow-up. One possible explanation consistent with these findings would be a rebound effect immediately after the completion of the group exercise sessions. Participants may have taken some time off during the week of postassessment after having exercised regularly during the program. It may also be that increasing activity level is simply difficult for these seniors, many of whom also have arthritis, back problems, or other conditions presenting barriers to exercise. Our findings show that, consistent with the results of Pratt et al. [31] and contrary to the expectations of some health care providers and earlier data [I], older citizens with diabetes can make substantial lifestyle changes if provided support and a program tailored to their needs. Our subjects represent a relatively hardcore group of patients who had a long history of diabetes and experienced a number of chronic diseases besides diabetes. In the words of our consulting diabetologist, “These patients had been through the mill of other approaches” without much success. The “Sixintervention is relatively ty Something...” brief and easy to implement. If its effectiveness can be replicated, this intervention package could be delivered in a variety of settings (e.g., senior citizen centers, hospitals, community centers or YMCAs). Additional studies are also indicated that (a) evaluate the program against more stringent control con-
ditions such as placebo controls that are equated for amount of contact time and (b) identify specific treatment components and processes associated with behavior change. One of the methodological strengths of this study was the inclusion of a broader range of outcome measures than most diabetes education studies, which often assess only improvements in knowledge and glycemic control [ 1,321. Inclusion of a broader array of measures including other behavior change indices, generalization measures including quality of life, and process measures allows better understanding of how the intervention works. We were pleased to see that the “Sixty Something...” program produced weight losses that were relatively well maintained, at least out to the 6-month follow-up. On the other hand, it was disappointing that behavior changes did not translate into larger reductions in GHb or improvements in quality of life. The glycemic control effects were in the expected direction but nonsignificant for the overall sample. The complexity and multidetermined nature of glycemic control results is illustrated by the stronger treatment effects observed among (a) subjects not treated with insulin and (b) subjects not experiencing changes in type of medication during the study. It is possible that the quality of life scale used was not the best measure for this population. The measure we selected was one of the scales from the Diabetes Control and Complication Trial, adapted for our sample of older Type II patients. Future investigations may want to use quality of life measures such as the Short Form of the General Health Survey from the Medical Outcome Study [33] on which there is good normative data, and/or develop diabetes-specific quality of life measures for this age group. As previous studies by both our own research group [34] and others have found [35], relations between behavior change and
12
physiologic measures of diabetes control are modest and complex. This issue deserves greater attention, but we feel it would be premature to conclude too quickly from such results that behavior change is not important for good control. There are numerous patient factors (age, gender, history of diabetes), medical status variables (insulin status, other conditions and medications), patient-provider interaction factors (appropriateness of regimen prescription) and other issues (e.g., timing and sequence of behavior changes and physiological change) that can potentially condition and moderate these relationships. Larger scale, more complex studies are needed to address these issues and to identify subgroups of patients whose diabetes is more and less responsive to behavior change [36]. The process measures help to understand treatment results. It was gratifying to see the consistent and significant improvements in both measures of problem solving. Even more encouraging were the findings that these improvements were maintained or even enhanced over the 6-month follow-up period. These results suggest that our problem-solving training; which formed a major part of the intervention, may have equipped participants
Table 6.
with relatively enduring skills to cope with the continuously changing array of barriers to diabetes adherence [ 11,371. It was surprising that we did not see improvements in self-efficacy given the significant behavior changes and previous findings in diabetes [25,38] and other areas [24,39] that self-efficacy often mediates or at least predicts behavior change. It may have been that ceiling effects on our self-eflicacy measure precluded our ability to detect further increases. In summary, this study demonstrates that older Type II diabetic subjects can make significant lifestyle changes if provided with appropriately tailored interventions. The overall pattern of results suggests that training in problem-solving skills may be an effective approach for improving diabetes self-care in this population. The study had a number of strengths including a randomized design, use of multiple dependent variables and low attrition rates. Future research should include such strategies and also extend the present research by evaluating the reach and costeffectiveness of such interventions, studying the process and longer-term effects of selfand including care outcome education, stronger measures of impact on patient quality of life.
Implications for practice. Acknowledgments
1.
2.
3.
4.
Patients age 60 and over have a much higher prevalence of diabetes and other chronic diseases, yet little attention has been devoted to health education programs for this population Older diabetic patients can improve in self-care despite long-standing lifestyle habits and coexisting chronic disease A short-term group program, focused on helping older patients develop specific plans for overcoming barriers to adherence and providing social support, was successful in producing and maintaining improvements Process measures such as problem solving appear to be important mediators of improvement in patient self-care
Appreciation is expressed to the Ames Company and especially David Jones for providing the memory analyzers for this project. We are also indebted to Dodie Weyhe, Ginny Osteen, Matt Riddle, Eddie McAuley, Janice Lettunich, and Willetta Wilson for their contributions to the project, and to Dr. Saul Toobert for suggesting the “Sixty Something...” title for the program. This research was supported by grant number 2 ROI DK 35524~04Al from the National Institute of Diabetes, Digestive and Kidney Diseases.
References I
2
Brown SA: Studies in educational interventions and outcomes in diabetic adults: a meta-analysis revisited. Patient Educ Couns 1990; 16: 189-215. Goodall TA, Halford WK: Self-management of diabetes mellitus: a critical review. Health Psych 1991; IO: l-8.
3
Wing RR. Epstein LH. Nowalk MP, Lamparski DM: Behavioral self-regulation in the treatment of patients with diabetes mellitus. Psycho1 Bull 1986; 99: 78-89.
4
Wing RR, Epstein LH. Nowalk MP, Koeske R. Hagg S: Behavior change, weight loss and physiological improvements in type II diabetic patients, J Consult Clin Psycho1 1985; 53: 1 II -122.
5
6
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8
9 10
1I
20
Wilson W. Pratt C: The impact of diabetes education and peer support upon weight and glycemic control of elderly persons with noninsulin dependent diabetes mellitus (NIDDM). Am J Pub1 Health 1987; 77: 634-635. Heath GW. Leonard BE, Wilson RH, Kendrick JS. Powell KE: Community-based exercise intervention: Zuni diabetes project. Diabetes Care 1987: IO: 579-583. Marrero DC, Kronz KK. Golden MP. Wright JC, Orr DP. Fineberg NS: Clinical evaluation of computerassisted self-monitoring blood glucose system. Diabetes Care 1989: 12: 345-350. Wysocki T: Impact of blood glucose monitoring on diabetic control: obstacles and interventions. J Behav Med 1989; 12: 183-205. 1980-1987. Surveillance, Diabetes USDHHS: Washtngton. DC: Centers for Disease Control, 1990. Harris MF. Hadden WC. Knowler WC, Bennett PH: Prevalence of diabetes and impaired glucose tolerance and plasma glucose levels in U.S. populations aged 20-74 yr. Diabetes 1987: 36: 523-534. Irvine AA. Saunders JT. Blank MB, Carter WR: Validation of scale measuring environmental barriers to diabetes-regimen adherence. Diabetes Care 1990: 13: 705-7 I I.
12
Glasgow RE, Toobert DJ. Riddle M, Donnelly J, Mitchell DL, (‘alder D: Diabetes-specific social learning variables and self-care behaviors among persons with type 11 diabetes. Health Psych 1989: 8: 285-303.
13
I4
McCaul KD. Glasgow behavtors: predicting 868-X8 I. Glasgow R. Toobert
15
outpatient diabetes education programs: how many patients take part and how representative are they? The Diabetes Educator. 1991; 5: 376-380. Welborn TA. Garcia-Webb P. Bonser A et al: Clinical
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17
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21 22 23
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27
28 29 30
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RE. Schafer LC: Diabetes regimen adherence. Med Care 1987; 25: 33 DJ. Hampson
S: Partictpation
in
crrterta that reflect C-peptide status in idiopathic diabetes. Diabetes Care 1983: 6: 315-316. Ary DV. Toobert D. Wilson W. Glasgow RE: A patient perspective on factors contributing to nonadherence to diabetes regimens, Diabetes Care 1986; 9: 168-172. Glasgow RE. McCaul KD. Schafer LC: Self-care behaviors and glycemic control in type I diabetes. J Chron Dis 1987; 40: 399-412. Block G: Health Habits and History Questionnaire: Diet History and Other Risk Factors. Washington. DC: National Cancer Institute. National Institutes of Health. 1988. ESHA Research: The Food Processor patible version. Salem. OR, 1987.
II, IBM and com-
34
35 36
37
38
Blair SN: How to assess exercise habits and fitness. In: Mattarazzo JD et al. eds. Behavioral
physical Health:
A Handbook of Health Enhancement and Disease Prevention. New York: Wiley, 1984. Tuckerman MM, Turco SJ: Human Nutrition. Philadelphia: Lea & Febiger. 1983. Bio-Rad Laboratories. Bio-Rad hemoglobin A,, micro column test. Instruction Manual. Hercules. CA, 1990 Diabetes Control and Complications Trial Research Group: Reliability and validity of a diabetes quality-oflife measure for the Diabetes Control and Compltcations Trial (DCCT). Diabetes Care 1988: I I: 725-732. Bandura A: Self-efficacy: toward a unifying theory of behavioral change. Psycho1 Rev 1977: X4: 191-215. Kingery PM. Glasgow RE: Self-efficacy and outcome cxpectations in the self-regulatton of non-msulin dependent diabetes mellitus. Health Educ 1989; 20. 13-19 Teri L. Lewinsohn PM: Modification of the pleasant and unpleasant events schedules for use wtth the elderly. J Consult Clin Psycho1 1982; 50: 444-445. Yesavage J. Brink T. Rose T, Lum 0. Huang 0. Adey V. Leirer V: Development of validation of a geriatric depressron screening scale: a preliminary report J P\ychratric Res 1983: 17: 37-49. Paulhus DL: Two-component models of social desirable responding. J Personality Sot Psycho1 1984; 46: 598-609. Toobert DJ, Glasgow R: Problem solving and diabetes self-care. J Behav Med 1991: 14: 71-X6. Block G, Lanza E: Dietary fiber sources in the United States by demographic group. J Nat1 Cancer lnst 1987: 79: 83-91. Pratt C. Wilson W, Leklem J. Kingsley L. Peer support and nutrition education for older adults with dtabetes. J Nutr Elderly 1987: 6: 31-43 Glasgow RE. Osteen VL: Evaluating diabetes education. Are we measurmg the most important outcomes’? Diabetes Care. in press. Stewart AL. Hays RD. Ware JE: The MOS short-form general health survey: reliability and validity in a patient population. Med Care 1988; 26: 724-735. Glasgow RE. McCaul KD. Schafer LD: Self-care behavrors and glycemic control of Type I dtabetes. J Chron Dis 1987; 40: 399-412. Johnson SB: Methodological issues tn diabetes research: measuring adherence. Diabetes Care. in press. Wing RR. Shoemaker M. Marcus MD. McDermott M, Gooding W: Variables associated with vveight loss and improvements in glycemic control in Type II diabetic patients tn behavioral weight control programs. Int J Obes 1990: II: 495-503. Glasgow RE. McCaul KD. Schafer LC: Barriers to regimen adherence among persons with insulin-dependent diabetes. J Behav Med 1986; 9: 65-77. Crabtree MC: Self-efficacy, social support. and social mcentives as predictors of diabetic self-care. type 11. Paper Behavioral presented at Society for Medicine. Washrngton.
DC. 1987
74
39
Bandura A: Social Foundations of Thought and Action: A Social Cognitive Theory. Englewood Cliffs, NJ: Prentice Hall, 1986.
Correspondence
to:
R.E. Glasgow Oregon Research Institute 1899 Willamette Street Eugene, OR 97401, USA
Education
Elsevier Scientific
and Counseling,
Publishers
19 ( 1992) 61-74
Ireland
61
Ltd.
Improving Self-Care Among Older Patients with Type II Diabetes: The “Sixty Something...” Study Russell E. Glasgow, PhD”, Deborah J. Toobert, PhD”, Sarah E. Hampson, PhD”, Jane E. Brown, BAa, Peter M. Lewinsohn, PhD” and Jodie Donnelly, RDb “Oregon
Research Institute.
IX99
Willamette
Street
Eugene,
OR 97401 und ‘Nutrition
Assoc~crte.v. .?.?.( Mill
Street.
Eu~cwv
OR 97401
(USA1
(Received
April 26th.
(Accepted
October
1991)
11th. 1991)
Abstract A IO-session, self-management
training program
was designed specifically for persons of age having learning
Type II diabetes.
variables, especially problem-solving
and self-efficacy, se&are
over 60 years
It targeted
found
to be related
in earlier correlational
skil1.s
to diabetes
research.
dred two adults were randomized
social
One hun-
to immediate
or
delayed intervention conditions. At posttest, subjects in the
immediate
intervention
significantly greater reductions percent The
of calories from fat
intervention
also
condition
showed
in caloric intake and
than control subjects.
produced
greater
reductions and increases in the frequency
weight
of glucose
testing than did the control condition. Improvements among immediate
intervention
subjects were gener-
ally maintained at a 6-month follow-up.
Intervention
results ,from subjects receiving
delayed
intervention
those for immediate
intervention
closely replicated subjects.
We conclude
program
can
improve
that a relatively
short-term
self-management
skills
of
older diabetic adults, and that there is an important need for such interventions.
Keywords:
Self-care; Diabetes Problem-solving; Older patients.
education;
Introduction
There have been numerous diabetes educa0738-3991/92/$05.00
Printed
and Published
1992 Elsevier Scientific in Ireland
0
Publishers
Ireland
tion studies, many of which have been summarized in recent reviews and meta-analyses [l-3]. However, relatively few studies are randomized trials or otherwise well controlled, and they tend to produce improvements in diabetes knowledge but less on measures of behavior change [l]. Few studies have improvement in patient self-care behaviors as their primary goal. Somewhat separate literatures evaluate interventions to improve dietary behavior [4,5], exercise [6], and glucose testing [7,8] but very few studies address all three self-care endpoints. There is a particular need for research on self-care programs for older diabetic patients. A large and increasing percentage of the population with diabetes is over 65 years of age [9,10]. Recent research suggests that the prevalence of diabetes is almost 10% among persons age 65 and older [9], and that these patients suffer a disproportionate amount of disease burden because it is often later in life that complications from diabetes appear. Older patients typically have received less diabetes education than their younger counterparts and often experience many more barriers to medical care [ 1I]. Unfortunately, there are very few studies of ways to improve diabetes self-care among older patients. The majority of diabetes education studies focus Ltd
62
on newly diagnosed patients, in particular, on adolescents and young adults with Type I diabetes. The present study describes and evaluates a program to improve diabetes self-care developed specifically for persons with Type II diabetes who are over 60 years of age. The intervention was based upon results from our previous research on psychosocial predictors of diabetes self-care behaviors [ 12,131. In addition, focus groups and evaluation interviews with older Type II patients were conducted to identify particular areas for intervention and barriers to self-care. Our approach was to develop an intervention that would be responsive to the needs of older persons, and would cognitive behavioral processes enhance previously found to prospectively predict selfcare such as self-efficacy and problem solving skills. This intervention was then evaluated in an initial randomized trial that included multiple measures of treatment outcome, a 6-month follow-up, and a quasi-experimental replication of intervention effectiveness. Method Design and procedures
A heterogenous group of outpatients who were 60 or more years of age and had Type II diabetes was recruited using a variety of methods described below. Patients meeting the inclusion criteria and wishing to participate were invited to attend one of several orientabaseline tion sessions. Those completing assessment were blocked on type of diabetes medication (insulin, oral medication or no diabetes medication) and then randomly assigned to either immediate or delayed intervention conditions. Following a 3-month interval during which Immediate Intervention subjects received the program, a second assessment session was held. After this posttest assessment, subjects in the Delayed Intervention condition received the intervention. Subjects in the Immediate Intervention condition received 6-month follow-up assessments to
evaluate the longer term effects of the program. Those in the Delayed Intervention condition were reassessed after completing the intervention to provide a quasi-experimental replication of the effects of intervention. Recruitment
Several steps were taken during the planning stage to enhance the appeal of the program to older adults. To overcome financial barriers, the program was offered free of charge and participants were provided glucose testing materials and a coupon for a pair of walking shoes. Both weekly meetings and exercise sessions were held during daylight hours in well-known, accessible, and pleasant facilities that earlier focus group participants had indicated would be most convenient. The “Sixty Something...” program was promoted extensively among local diabetes care professionals (e.g., internists and endocrinologists, diabetes educators, staff of local diabetes association) through presentations, mailings, and individual meetings prior to announcement to the general public. Patients of appropriate age under the care of physicians operating the three largest diabetes practices in the local area received a letter from their physician describing the project and encouraging participation. This was followed by a telephone call from project staff unless patients indicated they did not wish to be contacted. A similar letter and follow-up phone call procedure was employed with patients who previously participated in assessment research at Oregon Research Institute, as well as with members of the local diabetes association. Other recruitment activities involved notices and advertisements in a variety of media including the local newspaper (both classified and personal ads), newsletters of local and state diabetes associations, presentations at health fairs and other meetings, flyers distributed to major grocery stores and pharmacies, coverage on a local television program on community services, and public service announcements on the radio. More
63
detail on recruitment procedures and participation response rates are presented by Glasgow et al. [14]. Eligibility criteria for the program included being 60 years of age or older, being primarily responsible for one’s own self-care (institutionalized patients were not eligible), meeting the Welborn et al. [IS] clinical criteria for Type II diabetes, and not having major complications which would interfere with self-care (e.g., legally blind, severe stroke, on kidney dialysis). Subjects meeting these eligibility criteria were required to obtain their physician’s permission to participate and to pass a submaximal graded exercise test conducted at the University of Oregon Slocum Sports Medicine Laboratory. This exercise test was provided at no charge to participants. Subjects A total of 102 persons completed baseline assessment and were randomized into the study. Table 1 summarizes the characteristics of these subjects. As can be seen, there were no differences between conditions on these variables. The average age was 67 with 23% of participants over 70 years of age. As would be expected in this age group, there were more females than males participating. About onequarter of the participants were treated with insulin and another half were on oral medication for diabetes. Most patients had lived with their diabetes for a number of years and 88% also had other chronic diseases, the most common being arthritis and hypertension (both affecting 44% of subjects). Intervention The “Sixty Something...” program focused primarily on dietary and exercise self-care behaviors, and also included regular blood glucose monitoring with the Ames Glucometer Memory Meter. The reason for this focus was that our previous research has found that the lifestyle behaviors of diet and exercise are less well adhered to than more medical aspects of the diabetes regimen such
Table 1. Characteristics of participants: mean (and SD) or percent of patients by intervention condition.
Patient characteristic
lmmediate intervention (n = 52)
Delayed intervention (n = 50)
Age
67.1 (4.3)
67.2 (5.8)
Percent female
63.5
62.0
Diabetes medication (‘%I) Insulin 26.9 Oral medication 46.2 26.9 Diet only
26.0 50.0 24.0
Comorbidity (‘%I) No other diseases l-2 other diseases ~3 other diseases Diabetes history Years diagnosed Years with current physician ‘%previously attended diabetes education
II.5
12.0
34.6 53.8
38.0
9.4 (9.2) 4.7 (5.3)
50
50.0
9.5 (8.1) 5.8 (7.4)
44
[ 16,171. Also, particias taking medication pants in focus groups had rated diet and exercise as the areas in which they could most use assistance. Specific dietary targets included reducing caloric intake, decreasing consumption of fats, and increasing dietary fiber intake. For exercise, the goal was regular participation in low level aerobic activity, which for most participants involved walking or stationary bicycling. Individual goals for gradual improvement were set for each participant in the immediate intervention condition, based upon baseline levels of dietary intake and performance on the graded exercise test.
The program was led by an interdisciplinary team including psychologists, a American College of registered dietitian, Sports Medicine certified exercise leaders, and other educators. Group meetings of six to
64
twelve participants were held and the emphasis was on developing individualized plans to overcome barriers to adherence. The program focused on problem-solving, and participants were provided with example barriers and coping strategies identified from our previous research. Table 2 summarizes the content of each of the 10 sessions. Meetings followed a sequence of discussing the assignment from the previous week and sharing progress, followed by an informational presentation on a new topic (e.g., reducing dietary fat, increasing exercise, planning ahead for maintenance), and concluded with each participant completing a personalized goal-setting and coping strategy worksheet for the coming week. Groups met weekly for 8 weeks with all participants working on similar goals (e.g., decreasing caloric intake, increasing fiber consumption), followed by two meetings held at 2-week intervals during which participants chose the specific self-care area on which they wished to focus. Twice weekly group exercise (walking) sessions led by a trained exercise leader were held during the middle 8 weeks of the program. In addition, participants were
Table 2. “Sixty Session 1 2 3 4 5 6 7 8 (2 weeks) 9 (2 weeks) 10
Something...ORI
Primary
Diabetes Self-Care
review
Blood glucose monitoring
encouraged to exercise at least one additional time per week on their own. Participants were encouraged to share strategies and problem solutions with each other. The fifth and sixth sessions focused on increasing pleasant events, particularly those involving social interaction, and social interaction was encouraged during the walking sessions. The final two sessions focused on maintenance and relapse prevention. Information was presented on situations with high risk for developed inrelapse, and participants dividualized plans for coping with personal high-risk situations. Measures
A variety of measures were collected to evaluate the impact of the intervention on different outcomes and to identify the processes through which the intervention worked. Self-care outcomes. Multiple measures were collected of each of the targeted dietary and exercise self-care behaviors. Measures of average daily caloric intake, average percent of calories from fat, and average grams of dietary fiber per day were assessed using two procedures. First, participants completed the
Education Program”: outline of sessions. Main discussion
topic
Log of exercise activities Fat reduction goals Log of exercise activities Calorie reduction goals Mood and pleasant activity log Report on eating out assignment Fiber consumption goals
Exercise-basic concepts, foot care and safety, personal fitness profiles Decreasing fat consumption Exercise-integrating into daily activities Decreasing calories consumed Mood and pleasant events Social activities, eating out Increasing dietary fiber Personal goals
Goal attainment
Relapse Wrap-up
prevention,
coping with holidays
and assessments
In addition to the above, participants took part in supervised exercise (walking) sessions twice per week and were asked to exercise one other time per week using the buddy system.
65
dietary history portion of the Block/NC1 Health Habits and History Questionnaire [18]. Data were analyzed using software provided by the National Cancer Institute. In addition, participants were instructed in procedures for completing a 3-day food record and kept such a record for three consecutive days consisting of two weekdays and one weekend day. Participants received instructions about commonly omitted foods and a sample food record prior to beginning their food records. Completed records were reviewed with subjects, using food models and household measuring devices to clarify amounts consumed, and analyzed using the Food Processor II Nutrition and Dietary Analysis system [ 191. Average daily intake scores on each of the three dietary target behaviors from the diet history and food records were used for the analyses reported below. Physical activity was assessed using the Stanford 7-Day Recall [20]. This measure consists of an interview of participants about the amount of time spent in each of three levels of activity and is scored to produce a final measure of average kilocalories expended per day*. In addition, individualized goals were set for each participant in the Immediate Intervention condition based upon their baseline levels of dietary and exercise self-care. For diet, the daily caloric intake needed to maintain body weight was calculated for the participant’s age, gender, height and weight [21]. We then subtracted 500-800 calories from this figure to establish a caloric intake goal to be not less than 1500 calories/day for men and 1000 for women. Based upon this figure, a goal for grams of fat per day was set so that fat intake did not exceed 30% of this caloric target. For fiber the goal was to gradually increase dietary fiber up to a level of 30 g/day. For exercise, a goal of exercising at a *Due IO budgetary constraints, it was not possible post-intervention assessments of physical fitness.
to conduct
moderate aerobic level (65-75X of maximum heart rate) 4 days per week was established. Comparable goals were established (but not communicated) for Delayed Intervention subjects from their baseline data so that conditions could be assessed on comparable measures of goal attainment. Frequency of glucose testing was assessed using data that were directly uploaded from the subjects’ Glucometer M Memory meter to our computer. Other outcome measures. Glycosylated hemoglobin was measured using the BioRad A,, micro column method [22]. Normal values using this assay are from 4.2 to 5.9%. Weight was assessed in stocking feet using a Detect0 medical office scale. The other biological measure collected was average fasting blood glucose level. These data were obtained from the memory meter device built into the Glucometer M blood glucose monitoring machine. Impact of treatment on diabetes related quality of life was assessed via a modification of the DCCT Quality of Life Scale [23]. Twenty items from the impact subscale which were relevant to NIDDM were administered to produce a total score. Process measures. Several measures were collected to assess the processes through which the intervention was hypothesized to operate. Diabetes specific self-efficacy [24] was assessed using a measure that we have found to be consistently related to diabetes self-care [ 13,251.
Mood was assessed using two instruments: the Pleasant Events Schedule for Older Persons [26] and the Geriatric Depression Scale [27]. Both of these instruments have been validated and used extensively with older subjects. To determine the impact that social desirability might have on the self-report measures, we included the Balanced Inventory of Desirable Responding [28] which was covaried out from outcome scores on these variables.
66
Finally, problem-solving was assessed using a procedure that we have previously developed and found to be related to diabetes self-care [29]. Nine different scenarios were described and subjects were asked how they would respond to each situation. Using a standardized procedure, subjects were prompted for additional solutions. Responses were tape recorded and scored by coders to produce two summary scores: an average overall rating of problem-solving skill and the number of different solutions proposed. Interrater reliabilities on these summary scores for a randomly selected 25% of subjects revealed correlations ranging from 0.77 to 0.99 at the different assessment points, with an average of 0.89. Although the tape recorded interactions were not identified by treatment condition, in some cases the raters were aware of a given subject’s group assignment. However, given the objective nature of the scoring system and the relatively high interrater reliabilities, it is unlikely that knowledge of treatment condition affected the outcome of these summary scores. Results
Data were analyzed using the SPSS” statistical package. We first present data on baseline comparability of conditions on dependent variables, followed by information on subject attrition. Outcome results are then presented for targeted behavioral outcomes, and process measures. other endpoints, t-tests were used to Paired comparison evaluate change over time within each of the experimental conditions. For each of these sets of measures, analyses of covariance were then used to compare treatment conditions, covarying out the effects of pretest scores on posttest results. Additional analyses were also conducted on all self-report measures that covaried out the effects of social desirability. In every case the
conclusion from the analyses were the same as when using unadjusted scores. As can be seen in Table 3, the two conditions were very similar at baseline on almost all of the dependent variables. There were significant baseline differences on only one measure - average minutes of activity per day (F = 4.6, P < 0.05). There was very little subject attrition during the initial 10 week evaluation period. All 52 subjects in the Immediate Intervention condition and 49 of 50 subjects in the Delayed Intervention condition were assessed at posttest. By the time of the 6-month follow-up for the Immediate Intervention group, there was somewhat greater loss to follow-up: 48 or 92% of subjects were assessed at that point. Attendance during the program was also good, with participants attending 90% of self-care education sessions. Exercise sessions were not as well attended, with participants attending 60% of group exercise sessions on average. Targeted self-care behaviors
As can be seen in Table 3, the Immediate Intervention condition produced significantly greater posttest improvement on two of the three dietary targets than did Delayed Intervention. Data from food records indicated that intervention produced signilicant reductions in both overall caloric consumption and the percentage of calories from fat, while Delayed Intervention subjects did not change their fat intake and showed nonsignificant increases in caloric consumption. The Block Diet History Questionnaire produced calorie and fat intake results that were higher than those produced by the food records, but the pattern of changes was very similar to that observed on the food records. Between groups comparisons on the Block instrument were significant for percent of calories from fat, but not on caloric intake, despite a 200 kcal/day greater reduction in intake in the Immediate than Delayed Intervention condition. There were no significant within group changes or between condition differences on either measure of dietary fiber intake.
67
Table
3.
Self-care
Pretest,
posttest,
and follow-up
area
Mean calories per day 1. From Block/NC1 Immediate treatment Delayed treatment 2. From 3-day food record Immediate treatment Delayed treatment Mean percent of calories from fat I. From Block/NC1 Immediate treatment Delayed treatment 2. From 3-day food record Immediate treatment Delayed treatment Mean grams of fiber per day From Block/NC1 1. Immediate treatment Delayed treatment 2. From 3-day food record Immediate treatment Delayed treatment Mean number of days exercised Immediate treatment Delayed treatment
results
behaviors.
Pretest
Posttest
Follow-up/post
1979.9 (927.0) 2079.3 (1300.5)
1796.4 (702.0) 2083.3 (907.7)
1675.6’ (721.7) 1754.3 (777.5)
1631.6 (494.6) 1636.1 (412.5)
1468.2 (474.0)b.* 1686.0 (426.7)h
151 I .6 (432.7) 1413.5’ (355.7)
39.5 (8.9) 41.4 (8.5)
35.9 ( 7.6)h.’ 41.7 (8.0)h
37.0 (8.3) 36.4’ (7.5)
33.2 (7.2) 34.5 (8.1)
29.0 (6.7)‘.* 33.6 (6.0)h
29.6’ (8.5) 29.2’ (6. I)
19.3 (I 1.2) 20.8 (14.9)
21.0 (9.3) 19.6 (9.0)
17.6 (7.8) 20.1 (9.3)
20.9 (8.8) 19.9 (6.8)
21.7 (10.0) 21.0 (7.1)
20.4 (8.1) 22.0 (7.6)
4.4 (2.4) 3.7 (2.3)
4.5 (2.0) 3.7 (1.8)
3099.6 (762.2) 2900.0 (573.1)
Average minutes of activity per day Immediate treatment Delayed treatment
36.3 (5.2) 34.6 (2.1)
“Six-month bSignificant
self-care
Mean (and SD)
Mean energy expenditure by weight Immediate treatment Delayed treatment
?? Significant
on targeted
2997.8 (673.5) 2909.7 (557.6)
36.2 (3.2)h.* 34.5 (2.2)
TX”
4.4 (2.1) 4.6 (1.9)’
4227.8 (895.5)’ 2880.1 (615.3)
50.8 (4.7)’ 35.8 (4.6) _
improvement from pretest on this measure, follow-up for Immediate Treatment condition; posttreatment results for Delayed between treatment condition difference on analysis of covariance.
The improvements made by Immediate Intervention subjects in dietary behaviors were generally maintained at the 6-month followup. Reductions in both caloric consumption and fat intake were still significant on one of
Treatment
condition.
the two dietary instruments at this assessment and mean caloric intake from the Block instrument was (nonsignificantly) less than at posttest. Confidence in the replicability of these results is further increased by the
68
substantial reductions observed on these same variables among Delayed Intervention subjects when they received intervention (see Table 3). These reductions were equal to or greater than those observed among Immediate Intervention subjects and were observed on both food records and the Block instrument. Results on the individualized goal setting measures closely parallel those reported above for absolute levels of dietary self-care. A significantly higher proportion of Immediate Intervention than Delayed Intervention subjects had achieved these goals for caloric intake (29% versus IO%, P < 0.05) and fat consumption (45 versus 29%, P c 0.001) by posttest assessment. There were no significant intervention effects on personalized goals for fiber intake or days exercised. In contrast to the improvement shown on the targeted dietary measures, there was little short term effect on measures of exercise behavior. Posttest measures, collected 2 weeks following the conclusion of group exercise classes, showed neither significant changes
Table 4.
Results on generalization
Measure
from pretest levels nor between groups differences. By time of follow-up, however, subjects in the Immediate Intervention condition had substantially increased the average number of minutes of activity per day (see Table 3). Finally, data from the Glucometer M memory meter showed that subjects in the Immediate Intervention condition significantly increased the percent of days they tested their fasting blood glucose level compared to Delayed Intervention subjects. These improvements were not as well maintained as were other behavior changes, however. This may have been due at least in part to the fact that at follow-up, subjects were provided with many fewer strips than they had been at pretest and posttest. Other outcomes Table 4 presents results on other outcome measures. As can be seen, Immediate Intervention produced significant improvements compared to the Delayed Intervention condition, and to baseline, on weight. Glycosylated hemoglobin (GHb) levels significantly decreased for both Immediate Intervention
measures. Mean (and SD) Pretest
Posttest
Follow-up/replication”
188.0 (34.2) 184.5 (34.4)
182.2b,* (33.9) 185.9b (34.6)
186.1’ (32.6) 181.0’ (34.7)
6.8 (1.6) 7.4 (1.8)
6.3’ (1.5) 7.0 (1.5)
6.7 (1.7) 6.4’ (1.4)
Weight (in lb) Immediate intervention Delayed intervention
Glycosylated hemoglobin Immediate intervention Delayed intervention
Diabetes Quality of Life Scale 37.9 (8.8) 36.8 (8.0)
Immediate intervention Delayed intervention *Significant “Six-month dition. bSignilicant
improvement (P < 0.05) from pretest follow-up for Immediate Intervention between
treatment
condition
difference
38.1 (9.2) 37.2 (7.5)
38.2 (7.4) 36.3 (8.0) on this measure. condition; posttreatment on analysis
of covariance
results
for Delayed
at posttest.
Intervention
con-
69
Table Process
5.
Change
on process
measures.
measure
Mean (and SD) -_ Pretest
Problem-solving ability rating Immediate intervention Delayed intervention
Posttest
Follow-up/replication”
3.2 (0.5) 3.1 (0.5)
3.5h,* (0.4) 3.2h (0.5)
3.7* (0.6) 3.6* (0.6)
Number of problem-solving strategies used Immediate intervention 9.3 (2.6) Delayed intervention 8.8 (2.6)
10.5h,* (2.3) x.9h (2.9)
10.8’ (3.5) 10.6’ (2.6)
Self-efficacy: diet Immediate intervention Delayed intervention
81.2 (19.2) 85.5 (19.6)
78.7 (22.8) 79.1 (27.4)
74.9 (28.6) 77.2 (29.3)
Self-efftcacy: exercise Immediate intervention Delayed intervention
68.3 (26.3) 70.3 (24.5)
64.3 (31.8) 68.2 (27.7)
60.2 (33.9) 66.2 (31.2)
improvement (P < 0.05) from pretest follow-up for Immediate Intervention
on this measure. condition; posttreatment
-_ ‘Significant “Six-month dition. hSignificant
between
treatment
condition
difference
on analysis
and Delayed Intervention subjects, but there were no significant between groups differences. Although the magnitude of these changes was not large (6 lb weight loss and 0.5% on glycosylated hemoglobin), these changes were about what reasonably could be expected from a behavioral program of this intensity. There were few increases or decreases in medication over the course of the study, and no between groups differences on medication changes. Analyses of covariance at posttest on GHb for the subset of subjects not experiencing changes in the type of medication they were prescribed revealed a marginally significant effect in favor of intervention (F = 3.23, df = 1,90, P < 0.08). Supplemental analyses revealed that GHb reductions were larger among Immediate Intervention subjects not taking insulin than among those on insulin (0.7 versus 0.3%) and that the between groups intervention effects were marginally significant for noninsulin taking subjects (F = 3.56, df = 1,71, P < 0.06).
of covariance
results
for Delayed
Intervention
con-
at posttest.
Six-month follow-up results were generally encouraging. Subjects in the Immediate Intervention condition still weighed signiticantly less than at pretest (P < 0.002), and they had kept off most of the weight they had initially lost (4.5 lb of the initial 6 lb loss for subjects available at follow-up). Further support for the validity of the findings for the weight and glycosylated hemoglobin measures comes from the replication involving treated subjects in the Delayed Intervention condition. After receiving intervention, these subjects showed significant weight losses (5 lb) and reduction in GHb (0.6”%), both of which were very similar to reductions shown by Immediate Intervention subjects. Correlations between changes on behavioral measures and changes in physiological measures were modest, complex and somewhat inconsistent. The only statistically significant associations were between reductions in percent of calories from fat on the food
70
records (but not the Block questionnaire) and weight loss (Y k 0.33, P < O.Ol), and between changes in number of glucose tests per day and weight loss (r = -0.21, P < 0.05). There were no significant quality of life measure.
effects on the
Process measures
There were consistent and relatively large improvements associated with intervention on measures of problem solving. The Immediate Intervention group showed significant improvement at posttest in both measures of problem solving, the overall ability rating and the number of different strategies used. These increases were significantly greater than those in the Delayed Intervention condition (see Table 5). results on problem-solving Follow-up measures were even more encouraging. Subjects in the Immediate Intervention condition continued to improve on both measures over the follow-up interval. In addition, subjects in the Delayed Intervention condition showed significant improvement on both problemsolving measures following their treatment. These improvements were of approximately the same magnitude as those shown earlier by the Immediate Intervention condition, providing a replication of intervention effectiveness in improving problem solving. In contrast, there were no significant improvements on self-efficacy or mood Ievel. In the case of the self-efficacy measures, this may have been due partially to ceiling effects produced by high pretest scores on these measures (e.g., for dietary efficacy, 50% of subjects had pretest efficacy scores of 90 or higher on the IOO-point scale). Discussion
The “Sixty Something. ..” program was generally effective in producing behavior change on the measures of dietary intake and glucose testing behavior targeted for intervention. Confidence in the robustness of the di-
etary outcomes is enhanced by the similar pattern of results across two different assessment methods, food records and a sophisticated diet history measure. The Block/NC1 procedure gave higher absolute levels of both calories and percent of calories from fat, possibly suggesting that the food recording process may have been reactive. However, the most important findings were the consistency in the pattern of changes between conditions and over time. Both measures indicated substantial reductions in both calories and fats in the immediate Intervention condition (which were generally maintained over time), while the delayed condition showed few changes on either measure until intervention. The fact that the reductions in caloric intake and consumption of fats remained significant at follow-up and after adjusting for tendencies to give socially desirable responses further increases confidence in these results, as does the replication of these intervention effects observed when Delayed Intervention subjects received intervention. It is less clear why there were not corresponding significant increases in dietary fiber intake associated with treatment. One possibility is that subjects were already closer to recommended levels of fiber intake at baseline (20 g/day) than they were for caloric or fat intake. Average baseline dietary fiber intake of 20 g/day exceeded the national average of lo-12 g for white adults over 55 years of age [30] but baseline average percent of calories from fat (37%) was close to the national norm. Alternatively, it may be that fiber is a less familiar concept to subjects, which is less reinforced by the media and environment than reductions in either calories or fat intake, and consequently harder to change. A third possibility is that the fiber intervention came toward the end of the program and it may have been difficult for participants to make additional dietary changes. The two physical activity measures showed somewhat different patterns of results. Treat-
71
ment subjects were already fairly active in terms of number of days exercised per week at baseline (almost 4.5) and it may not have been realistic to expect further increases. Such an explanation would be consistent with the significant improvement to this 4.5 days per week level following treatment shown by Delayed Intervention subjects, who were exercising less frequently at baseline (see Table 3). It is more difficult to explain why there was not short-term improvement in number of minutes exercised per day. Also, there appeared to be a delayed effect of intervention in which Immediate Intervention subjects demonstrated a significant increase in minutes exercised at follow-up. One possible explanation consistent with these findings would be a rebound effect immediately after the completion of the group exercise sessions. Participants may have taken some time off during the week of postassessment after having exercised regularly during the program. It may also be that increasing activity level is simply difficult for these seniors, many of whom also have arthritis, back problems, or other conditions presenting barriers to exercise. Our findings show that, consistent with the results of Pratt et al. [31] and contrary to the expectations of some health care providers and earlier data [I], older citizens with diabetes can make substantial lifestyle changes if provided support and a program tailored to their needs. Our subjects represent a relatively hardcore group of patients who had a long history of diabetes and experienced a number of chronic diseases besides diabetes. In the words of our consulting diabetologist, “These patients had been through the mill of other approaches” without much success. The “Sixintervention is relatively ty Something...” brief and easy to implement. If its effectiveness can be replicated, this intervention package could be delivered in a variety of settings (e.g., senior citizen centers, hospitals, community centers or YMCAs). Additional studies are also indicated that (a) evaluate the program against more stringent control con-
ditions such as placebo controls that are equated for amount of contact time and (b) identify specific treatment components and processes associated with behavior change. One of the methodological strengths of this study was the inclusion of a broader range of outcome measures than most diabetes education studies, which often assess only improvements in knowledge and glycemic control [ 1,321. Inclusion of a broader array of measures including other behavior change indices, generalization measures including quality of life, and process measures allows better understanding of how the intervention works. We were pleased to see that the “Sixty Something...” program produced weight losses that were relatively well maintained, at least out to the 6-month follow-up. On the other hand, it was disappointing that behavior changes did not translate into larger reductions in GHb or improvements in quality of life. The glycemic control effects were in the expected direction but nonsignificant for the overall sample. The complexity and multidetermined nature of glycemic control results is illustrated by the stronger treatment effects observed among (a) subjects not treated with insulin and (b) subjects not experiencing changes in type of medication during the study. It is possible that the quality of life scale used was not the best measure for this population. The measure we selected was one of the scales from the Diabetes Control and Complication Trial, adapted for our sample of older Type II patients. Future investigations may want to use quality of life measures such as the Short Form of the General Health Survey from the Medical Outcome Study [33] on which there is good normative data, and/or develop diabetes-specific quality of life measures for this age group. As previous studies by both our own research group [34] and others have found [35], relations between behavior change and
12
physiologic measures of diabetes control are modest and complex. This issue deserves greater attention, but we feel it would be premature to conclude too quickly from such results that behavior change is not important for good control. There are numerous patient factors (age, gender, history of diabetes), medical status variables (insulin status, other conditions and medications), patient-provider interaction factors (appropriateness of regimen prescription) and other issues (e.g., timing and sequence of behavior changes and physiological change) that can potentially condition and moderate these relationships. Larger scale, more complex studies are needed to address these issues and to identify subgroups of patients whose diabetes is more and less responsive to behavior change [36]. The process measures help to understand treatment results. It was gratifying to see the consistent and significant improvements in both measures of problem solving. Even more encouraging were the findings that these improvements were maintained or even enhanced over the 6-month follow-up period. These results suggest that our problem-solving training; which formed a major part of the intervention, may have equipped participants
Table 6.
with relatively enduring skills to cope with the continuously changing array of barriers to diabetes adherence [ 11,371. It was surprising that we did not see improvements in self-efficacy given the significant behavior changes and previous findings in diabetes [25,38] and other areas [24,39] that self-efficacy often mediates or at least predicts behavior change. It may have been that ceiling effects on our self-eflicacy measure precluded our ability to detect further increases. In summary, this study demonstrates that older Type II diabetic subjects can make significant lifestyle changes if provided with appropriately tailored interventions. The overall pattern of results suggests that training in problem-solving skills may be an effective approach for improving diabetes self-care in this population. The study had a number of strengths including a randomized design, use of multiple dependent variables and low attrition rates. Future research should include such strategies and also extend the present research by evaluating the reach and costeffectiveness of such interventions, studying the process and longer-term effects of selfand including care outcome education, stronger measures of impact on patient quality of life.
Implications for practice. Acknowledgments
1.
2.
3.
4.
Patients age 60 and over have a much higher prevalence of diabetes and other chronic diseases, yet little attention has been devoted to health education programs for this population Older diabetic patients can improve in self-care despite long-standing lifestyle habits and coexisting chronic disease A short-term group program, focused on helping older patients develop specific plans for overcoming barriers to adherence and providing social support, was successful in producing and maintaining improvements Process measures such as problem solving appear to be important mediators of improvement in patient self-care
Appreciation is expressed to the Ames Company and especially David Jones for providing the memory analyzers for this project. We are also indebted to Dodie Weyhe, Ginny Osteen, Matt Riddle, Eddie McAuley, Janice Lettunich, and Willetta Wilson for their contributions to the project, and to Dr. Saul Toobert for suggesting the “Sixty Something...” title for the program. This research was supported by grant number 2 ROI DK 35524~04Al from the National Institute of Diabetes, Digestive and Kidney Diseases.
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Correspondence
to:
R.E. Glasgow Oregon Research Institute 1899 Willamette Street Eugene, OR 97401, USA
