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Journal of Alzheimer’s Disease 43 (2015) 167–176 DOI 10.3233/JAD-141179 IOS Press

Impact of a Therapeutic Educational Program on Quality of Life in Alzheimer’s Disease: Results of a Pilot Study H´el`ene Villarsa,∗ , Charlotte Dupuya,b , Am´elie Perrina , Bruno Vellasa,c and Fati Nourhashemia,c a Toulouse

University Hospital, Department of Geriatric Medicine, Toulouse, France 1027, University of Toulouse III, Toulouse, France c Inserm U558, University Toulouse III, Toulouse, France b Inserm

Accepted 26 May 2014

Abstract. Background: Therapeutic patient education is expanding in the field of Alzheimer’s disease (AD). Objective: To evaluate the impact of a therapeutic educational program, on AD-affected patients and their caregivers, living in the community, on the patient’s quality of life. Methods: Non experimental before and after study. Patient/caregiver dyads were recruited in the geriatric department of the Toulouse University Hospital. The intervention consisted of an educational program, designed for both patients and caregivers. It included two individual sessions (at baseline (M0) and two months later (M2)) and four group sessions for caregivers only, one per week between M0 and M2. The primary outcome was the patient’s quality of life at two months, hetero-evaluated by the caregiver. We compared the QoL-AD score between M0 and M2 with a paired Student’s test. The secondary outcomes were patient’s autonomy (activities of daily living) and caregiver’s burden (Zarit Burden interview). Results: 29 patient/caregiver dyads were recruited. The QoL-AD score was 24.6 ± 5.1 at M0 versus 27.2 ± 6.0 at M2 (p = 0.038). This difference is statistically significant. There was no difference in the secondary outcomes. Conclusion: This study revealed a significant positive impact of a therapeutic educational program on patients’ quality of life. Our results led us to design a randomized controlled trial called the THERAD study (THERapeutic education in Alzheimer’s disease). It started in January 2013, and the results will be available in 2015. If the efficacy of this approach is proven, it will be important to implement educational programs in the care plan of these patients. Keywords: Alzheimer’s disease, therapeutic education, caregiver, quality of life

INTRODUCTION Therapeutic patient education (TPE) is a basic, lasting component of patient management, according to the World Health Organization definition [1]. It covers organized activities designed to make patients and their relatives fully aware about their disease. TPE helps patients and their relatives acquire or maintain the skills they need to manage their life with a chronic disease. This approach recently has become one of the ∗ Correspondence to: Dr H´ el`ene Villars, Toulouse University Hospital, Department of Geriatric Medicine, 170 avenue de Casselardit, 31059 Toulouse, France. Tel.: +33 5 61 77 64 27; Fax: +33 5 61 77 64 86; E-mail: [email protected].

components of the care for Alzheimer’s disease (AD) affected patients and their caregivers [2–6]. Such programs are difficult to implement in the field of AD because of the specific characteristics of the disease: cognitive impairment, especially memory loss, and anosognosia. Indeed, the patient’s skills to acquire abilities and modify his/her behavior are impaired. The relationship with the caregiver appears to be the support of any educational approach. A variety of interventions, including psychoeducational programs, have consistently shown significant positive effects in patients with moderate to severe AD as well as in their caregivers [2–6]. In the literature, studies focusing on the specific impact of therapeutic educational

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programs on AD patients and their caregivers are few and recent. The assessment of the effectiveness of these interventions is based on judgment criteria mostly concerning the caregiver (depression, quality of life, and burden) who appears to be the real beneficiary of the psychoeducational approach [7, 8]. Indeed it has been proven that informal caregivers of AD patients are at risk of suffering from psychological and physical exhaustion [9]. Several studies have demonstrated that such educational programs can improve the caregiver’s quality of life or decrease his/her depression and burden [10–13]. A few studies have also evaluated the effectiveness of multidimensional psychoeducation interventions on the AD patient him/herself [14–18]. Two trials showed that a multidimensional intervention including educational activities (associated, as appropriate, to respite, psychological support, and/or pharmacological treatment) decreases behavioral and psychological symptoms of dementia (BPSD) [14, 15]. A metaanalysis suggests that the most effective interventions to reduce patient’s BPSD and their caregiver’s burden are those that include a psychoeducational program for caregivers and a follow-up [16]. Finally, by combining respite, therapeutic education, and caregiver support, psychoeducational programs can improve the patient’s quality of life [17]. In this study we tried to evaluate the impact of a therapeutic educational program designed for both AD patients and their caregivers on the patient’s quality of life. Indeed, combined interventions targeted at both patients and caregivers have demonstrated a positive impact on patients’ and caregivers’ outcomes [6]. We chose the patient’s quality of life as the primary outcome because it is a global, multidimensional, and relevant criterion in the management of chronic diseases. Moreover, it is increasingly being used as a primary outcome of intervention studies in the field of dementia [10, 19]. To our knowledge, two randomized controlled trials have been conducted in patients with mild [2] and mild to moderate [3] AD and their primary caregivers to evaluate the impact of a psychosocial and psychoeducational support program [2, 3]. This pilot study was the first step of the development of a randomized controlled trial (RCT) called THERAD (THERapeutic education in Alzheimer’s Disease) that is currently in its inclusion period. The object of this study was to evaluate whether a therapeutic educational program designed for both AD patients and their caregivers has an effect on the patient’s quality of life after two months. It is designed for mild to moderately severely affected

patients, living in the community, and their primary caregivers. METHODS Study design This study is a monocentric non-experimental, nonrandomized, non-controlled before and after study. Participants This study has been conducted in the geriatric department of the Toulouse University Hospital in France. Participants were recruited from the memory clinic and the geriatric units of the Toulouse University Hospital in France, between January 1, 2010 and January 31, 2011. Eligible to participate in the study were dyads of patients affected suffering from AD with no limit of Mini-Mental Score Examination score (MMSE) [20], living in the community, and their primary caregiver. The diagnosis of AD was based on the clinical criteria of AD from the Diagnostic and Statistical Manuel of Mental Disorder (fourth Edition DSMIV) [21] and the criteria for probable Alzheimer’s disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) [22]. Each patient underwent an MRI or CT scan and biological tests. We performed laboratory tests to help diagnose AD. These tests are: complete blood count, serum electrolytes (sodium, potassium, calcium, chloride, phosphate), serum creatinin and urea, glucose, serum albumin and total protein, vitamin B12 and folates, thyroid-stimulating hormone, ALP, AST, ALT Gamma-GT, and bilirubin. The primary caregiver was defined as a nonprofessional person living with the patient or providing frequent support (at least 8 hours a week). Patients of both genders, with no age limit, fulfilling the inclusion criteria were involved. Twenty-nine dyads were recruited. Inclusion and exclusion criteria are presented in Table 1. Primary outcome The primary outcome measure was the patient’s quality of life assessed by the Logsdon QOL-AD [23], hetero-evaluated by the caregiver. We chose this criterion because it is a global, multidimensional, and relevant criterion in the management of chronic

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Table 1 Inclusion and exclusion criteria Inclusion criteria

Exclusion criteria

Patient suffering from Alzheimer’s disease, with or without cerebrovascular component, at every stage Patient living in the community Patient supported by a primary caregiver, living with him/her or providing help (8 hours a week) Patient who received, through his legal representative if necessary, information concerning the study and who agreed to participate Patient whose caregiver was informed and has agreed to participate Subjects covered by a health insurance system

Patient affected with another type of dementia

diseases. Moreover it is a validated tool in our population [24]. This scale can be completed by the patient or the caregiver. Considering that self-assessment could be difficult for mild to moderately severe AD patients, we chose to use the hetero-evaluation assessed by the primary caregiver as the primary outcome. Secondary outcome Our secondary outcomes were the patient functional autonomy in daily living activities assessed by the Katz Activities of Daily Living (ADL) [25] and the primary caregiver’s burden assessed by the Zarit Burden interview (ZBI) [26]. We also collected data on the participant’s satisfaction. Intervention The intervention consisted of a therapeutic educational program including two individual sessions and four group sessions. It focused on empowering caregivers to find the resources in their lives, according to the principles of self-validation. It was designed to make participants fully aware of disease-related problems. The content of each session was tailored to help participants acquire or maintain the skills they need to manage the life with the disease. The total duration of the program was two months while it has been pointed out in a systematic literature review that intensive and long programs are not more effective than brief programs [6]. The pedagogic method and tool are those currently used in therapeutic educational programs [1, 27]. We used tools such as storytelling or drawings that allow us to explore the subject’s representations and worries [28]. We also used computer-based activities and brain-

Institutionalized patients (nursing home, long-term care unit) Patient with no caregiver Patient who refused to participate Patient whose primary caregiver has not agreed to participate Patient whose caregiver is less than ≥18 years old or deprived of their freedom by administrative or judicial decision, or is under guardianship Patient undergoing another research protocol that may impact his/her quality of life (therapeutic trial)

storming, commonly used in health education, that are promising in the field of patient education [27]. All visits and assessments were performed by geriatricians, hospital practitioners trained in therapeutic education. Patients received an individual session, at baseline (M0) and two months later (M2). The caregivers underwent the same individual sessions (M0 and M2) but also four group sessions, one per week during four weeks between M0 and M2. It was important to collect the patient’s representations and beliefs about the disease, useful data for the educational process of the dyad. We therefore proposed individual sessions to patients but group sessions for caregivers only. The group sessions were conducted in small groups (6 to 8 caregivers), each lasting 3 hours. At the baseline visit (M0) the patient was seen in consultation led by a geriatrician, including a clinical examination and a comprehensive geriatric assessment (CGA) [29] (MMSE, weight, one-leg balance, sensorial impairment, comorbidities, pharmacological and non-pharmacological therapies). The primary and secondary outcomes were assessed: QoL-AD reported by the caregiver; patient’s ADL and caregiver’s burden by ZBI. At the end of the M0 visit, the educational diagnosis of the dyad was performed, as the first step of the educational process. The AD patient’s educational diagnosis was supported by a specific tool, developed by the French Ministry of Health [30]. This tool is a booklet specifically designed for patients. It is performed as a semi-directive interview with patientcentered communication techniques, and educational techniques. This educational diagnosis was then linked with the caregiver’s one in order to establish a semitailored plan with learning priorities for the caregiver depending on the patient’s educational diagnosis (e.g., to adapt his/her communication style in stressful situations). The intervention was supported by the use of

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H. Villars et al. / Therapeutic Education in Alzheimer’s Disease Table 2 Objectives and topics of the individual and collective sessions of the educational program Objectives

Individual session

Group session 1 (S1): Knowledge of the disease

Group session 2 (S2): Pharmacological and non-pharmacological treatments. Behavioral and psychological symptoms of dementia

Group session 3 (S3): Crisis situations. Prevention of caregiver’s exhaustion

Group session 4 (S4): Assistive devices and care pathways

Individual session

a monitoring scheme established at this step. A formal document was delivered to patients, called the ‘Alzheimer’s Card’, also developed by the French Ministry of Health [31]. This card included information on disease management (e.g., name of the family practitioner, drugs taken, phone number of the relatives) and provides counselling in legible and understandable form for cognitively impaired subjects. This part of the educational process enables the team to understand the different aspects of the patient’s personality and life history, as well as those of the caregiver. It allows the identification of their needs, assessment of their potential, and consideration of their requests. Its key purpose is to help the dyad to formulate a project [1, 27]. Then the caregiver underwent collective sessions, each one focusing on a specific aspect of the disease. Contents of the group sessions are summarized in Table 2. The collective sessions focused on providing caregivers with knowledge about the disease, as well as, for

– patient: educational diagnosis (personality, beliefs, needs, requests). The objective of this session was to understand the patient’s history of life and life with the disease. – caregiver: educational diagnosis (same components). Its major purpose was to help the caregiver formulate a project by identifying skills to acquire or strengthen and defining realistic goals to reach The objective of this session was to establish a semi-tailored plan for the dyad with learning priorities for the caregiver – To identify the impairment of the patient’s cognitive function – To identify the residual abilities in daily living activities – To know the non-pharmacological measures to be implemented to maintain functional autonomy – To understand the effect of pharmacological treatments – To identify behavioral and psychological symptoms of the disease – To implement non-pharmacological measures to prevent those symptoms – To identify situations at risk of complications (treatment modification, concomitant illness, change of environment, relocation) – To recognize and prevent caregiver’s burnout – To understand assistive devices, respite solutions, and legal aspects raised by the disease – To know the resources available in crisis or emergency situations (general practitioner, specialist consultation, hospitalization) – patient: evaluation and reformulation of personal objectives – caregiver: evaluation of the educational process and reformulation of their personal objectives: ‘achieved’, ‘to reach’, ‘new goals’ and ‘acquired skills’ The objective was to evaluate the educational process, to collect the participant’s satisfaction, and to deliver additional advice based on this evaluation, to both the patient and the caregiver

example, strategies and skills to cope with the patients’ behavioral symptoms and advice about referral to community resources. In each session, the participants were offered guidance with common decision making and means to identify and solve problems. They were also offered advice to find new ways of managing everyday life and construct a meaningful life. The program was semi-tailored (some components common for all participants and some tailored for the needs of an individual caregiver) Each session was flexible, adapting the topics of the specific objectives of the participants and to the group dynamics. They were conducted by a geriatrician (S1 and S2) and a nurse (S2, S3 and S4), also trained in therapeutic education, in tandem with stakeholders belonging to the geriatric units: pharmacists (S2), psychologists (S3), and social workers (S4). After the group session, the dyads received an individual session, the second month’s session (M2). It consisted of a medical consultation, including a clinical examination and a CGA of the patient, and

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an assessment of our primary and secondary endpoints. It included the continuation of the educational process with a reformulation of their personal objectives: ‘achieved’, ‘to reach’, ‘new goals’ and ‘acquired skills’. We try to deliver additional advice based on this evaluation, to both the patient and the caregiver. The patient was interviewed, using the booklet, on his/her well-being. Emerging goals were also detected. The participant’s satisfaction was also reported. The M2 visit was concluded by an individual session continuing the educational process. Then, the participants’ satisfaction regarding the program was collected with a feed-back questionnaire. This questionnaire was addressed to caregivers and delivered at the end of the fourth group session. We asked caregivers to give their opinion regarding the form and emphasis of each session (contents, ‘answer to your needs’, ‘conformity with your expectations’) and also regarding the program as a whole (duration, number, and rhythm of sessions). We used a scale inspired by the visual analogue scale to evaluate this satisfaction. Those qualitative data were collected and analyzed. This was as a part of the educational process, but it also allowed us to enhance and enrich the intervention proposed in the randomized controlled trial. Statistical analysis Data were analyzed with STATA v11.0 (Stata Corp., College Station, TX, USA). The subject’s characteristics were summarized using means and standard deviations or frequencies and percentages, as appropriate. The normality in the distribution of variables was verified with skewness and kurtosis tests. Comparisons between before and after the intervention were performed using the paired student’s test. P-value less than 0.05 were considered as statistically significant. We performed bi-variate analysis and, secondly, additional logistic regression analysis. RESULTS Twenty-nine patient/caregiver dyads were included in the program between January 1, 2010 and January 31, 2011. The characteristics of the dyads patient/caregiver are listed in Table 3. The mean age of patients was 80 ± 7.8 years; 51.7% of them were women. The median score of MMSE was 18 [14–20], and the median disease duration was 24 months [7, 8–48]. Caregivers were female in 58.6%; 77.8% of them lived with the patient; 48.3% of them

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Table 3 Patients’ and caregiver’s characteristics Characteristics of the dyads patient/caregiver Mean ± SD or n (%) Patient (n = 29) Age (years) Gender: female MMSE score (n = 27)* Disease duration (month)* BPSD (NPI) (n = 16) Anti-dementia drugs (n = 28) Caregiver (n = 29) Gender: female Living with patient – Spouse – Child – Other (siblings, friend, companion)

80.0 ± 7.8 15 (51.7) 18 [14–20] 24 [7.8–48] 43.8 ± 25.1 23 (79.3) 17 (58.6) 21 (77.8) 14 (48.3) 13 (44.8) 2 (6.9)

*median [p25-p75]. MMSE, Mini-Mental State Examination; BPSD, Behavioral and psychological symptoms of dementia; NPI, Neuropsychiatric Inventory.

were spouses, 44.8% of them were children; in 6.9% of cases there was a sibling/friend or companion. On average, caregivers received 3.65 ± 0.72 group sessions. The quality of life of the patient assessed by the QoL-AD Logsdon scale was 24.6 ± −5.1 at M0 versus 27.2 ± 6.0 at M2 (p = 0.038). This difference is statistically significant. The median independency assessed by ADL was 5 [4.5–6] at M0 visit versus 5 [4.5–6] at M2 visit (p = 0.1873). The caregiver’s burden assessed by Zarit was 36.9 ± 18.7 at M0 visit versus 41.1 ± 22.0 at M2 visit (p = 0093). There was no significant difference in patient’s autonomy nor caregiver’s burden between M0 and M2 (Table 4). Bi-variate analysis and logistic regression analysis found no significant difference for the different clinical characteristics, in the changes of QOL-AD score between M0 and M2. DISCUSSION Our study shows that an educational program targeted at both patient and caregiver can significantly enhance the patient’s quality of life proxy-rated. The main explanation for this is that by transmitting knowledge, expertise, and skills to the patient’s caregiver, he/she is able to modify his/her behavior so that the patient’s quality of life can improve. It has been demonstrated that TPE can lead to changes in patient’s lifestyle and behaviors in many chronic diseases. Some studies have showed a positive impact of educational programs on patients’ self-management behavior, notably on adherence to medication [32], and

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H. Villars et al. / Therapeutic Education in Alzheimer’s Disease Table 4 Results

Patient QoL-AD/52 points Katz’s ADL*/6 points Caregiver Zarit’s burden*/88 points

M0

M2

Difference

24.6 ± 5.1 5 [4.5–5]

27.2 ± 6.0 5 [4.5–6]

−2.60 0.0

40 [20.5–50.5]

38 [23.5–62.5]

2

Confidence interval, 95%

p(1)

[−5.05; −0.16] [−0.55; 0.16]

0.038 0.1873

[−9.03; 0.74]

0.093

*median [p25-p75]. Paired Student’s test.

health behaviors in general [33–35]. The efficacy of TPE has been proven to modify behaviors and promote changes in life, for example in diabetes and asthma [36, 37]. With regards to the potential benefit of educational programs directed to both patients and caregivers, it has also been demonstrated that these programs can modify the relatives’ attitudes, notably in pediatric care [38] and in psychiatric care [39–41]. Evidence from trials suggests that psychoeducational approaches, including family, can have a positive impact on the patient’s outcomes [40, 41]. Given the results in the literature, it is was reasonable to make the hypothesis that TPE could lead to a change of caregiver’s attitudes toward his/her relative and, thus, to an improvement of the patient’s quality of life. Our results consolidates the theory that TPE is useful as a tool in such chronic diseases as neurodegenerative ones. We tried to identify co-associations with additional analysis, in order to better interpret our result, but we found no significant difference for the different clinical characteristics. This may be due to the small sample size of the study. With regards to population, we chose to target both the patient and the caregiver, as a dyad, for many reasons. First, the AD patient is too often excluded from any educative relationship with the physician, although the diagnosis is increasingly made at a very mild stage of the disease that allows him/her to be engaged in this type of partnership. In addition, a systematic review of evidence of the effectiveness of educational and supportive strategies, addressed to caregivers of AD patients, has demonstrated that interventions that jointly engage people with AD and their caregivers in education and training living in the community are the most successful [6, 42]. Concerning the primary outcome of the study, we chose the patient’s quality of life which, in our view, is an important aspect of the care of these subjects. Indeed, in clinical trials conducted in this population, the improvement of cognition and/or autonomy are the main outcomes with, unfortunately, poor results [2, 3]. On the other hand, quality of life is a criterion that

meets the overall objectives of any therapeutic educational action in the care of chronic diseases. Finally it has never been used in the field of therapeutic education in AD. A randomized controlled trial, DAISY (Danish Alzheimer Intervention Study), has demonstrated that a psychosocial counseling and support program for outpatients with mild AD and their primary caregivers induces a small, but non-significant, improvement of the patient’s depression (assessed by the Cornell depression scale score [43]) in the intervention group [2]. This seems to be in accordance with our results, while mental health, even in the particular case of subjects suffering from dementia, is an important part of the quality of life as a whole. With regards to intervention, our program was close to another intervention tested in a RCT called the AIDMA study (psycho-educational program assistance to caregivers of Alzheimer’s patients) [3]. This trial included randomly 167 AD dyads, with patients at mild to moderate stages and treated with cholinesterase inhibitors in two groups (intervention and control). Its intervention was a 12 structured sessions of 2 hours once a week for 12 weeks targeted to caregivers. It focused on problem-solving techniques and coping strategies, management of patients’ behaviors, and crisis management. At 6 months, the patient’s primary outcome (functional independence measured by the Disability Assessment for Dementia [44]) was comparable in the two groups. Meanwhile, caregivers in the intervention group have significantly a better ‘understanding of the disease’ and a better ‘ability to cope’ as assessed by the SCQ at 6 months. In addition, caregivers in the control group have an increased (but not significantly) score at the depression scale on the Montgomery Asberg Depression Rating Scale [45]. The main difference between this intervention and ours is that AIDMA also includes a pharmacological aspect (patients were treated with cholinesterase inhibitors). However, the educational approach was very close to ours. The contents of the sessions, their duration, and the group size were similar. By contrast, we planned only four group sessions, once a week, while the

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AIDMA intervention was composed of 12 structured sessions, once a week for 12 weeks. We chose this format because, as previously mentioned, the literature review does not suggest that intensive and long programs are more effective than brief ones. The other similar intervention is the one of the DAISY study, previously mentioned [2]. In this trial, 330 AD dyads, with patients at mild stage of the disease, were enrolled. The primary outcome was, for patients, cognitive status (MMSE [20]), depression (Cornell depression scale for dementia [43]), and European quality of life visual analogue scale (EQ-VAS) proxy rated [46]. The primary outcomes for caregivers were depression (GDS) and Eq-VAS [46]. The intervention in DAISY was a multifaceted and semi-tailored counselling, education, and support. It combined counselling sessions with both patients and caregivers, courses for patients and caregivers, and additional intervention (phone calls). The trial has demonstrated that a psychoeducational intervention leads to a small, although non-significant, difference in the patient’s depression (assessed by the Cornell depression scale score [43]) in the intervention group [2]. In our intervention, we chose to implement TPE instead of courses (as proposed in the DAISY study) because educational group sessions are more interactive than courses. The way information and knowledge are delivered is, in our opinion, an important aspect of the potential effect of this type of intervention. We chose a person-centered approach. The group session addressed caregivers only, whereas patients received courses in DAISY. Lastly, we targeted more severely affected patients (mild to moderately severe) because it has been demonstrated that decline in quality of life at mild stages of the disease is due to cognitive function [23] on which educational interventions has not demonstrated any positive impact [2]. In our small pilot study, we tried to implement the same approach but we targeted more severely affected patients, and proposed a program of shorter duration. The encouraging results of this pilot study led us to design the RCT THERAD that started on January 1, 2013 and is currently in its inclusion period. This study will enroll a sample of 170 AD patient/caregiver dyads, of whom 110 have already been recruited. There is a need for a clinical trial in this field to evaluate the impact of such an approach, especially since programs do already exist, for example in France and elsewhere in Europe [47, 48]. We found no significant difference in the patient’s autonomy nor the caregiver’s burden. A previous study

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has examined the patient’s autonomy, without any positive impact [3]. This is in accordance with our results. The negative results of our study consolidate, in a way, the positive ones, while highlighting that we have indeed targeted well the patients themselves. As a matter of fact, we did not provide support, in the true sense of the word, to the caregiver but basically coaching, in order to enable them to modify their behaviors with the patient. Our study has several limitations. It is a nonexperimental, non-controlled, before and after study. We chose this methodology in view of several factors. First, this work was the first step in the development of a randomized controlled trial and needed to be feasible in clinical routine. Then, our objective was to implement an intervention, to monitor its satisfactory progress, and to assess its potential impact in order to enhance the future intervention of the RCT. The before-and-after design was, in our opinion, realistic for a pilot study evaluating the immediate impact of a short-duration program. However, we were aware of the potential confounding factors (e.g., hospitalization, pharmacological treatments) and therefore decided to collect them in the RCT. Lastly, we chose a before and after study because the evolution of quality of life in AD is slow, so it has a minimal effect for a period of 2 months [49]. The main limitation is the small sample size. Indeed, it was difficult to enroll dyads in usual care, due to the caregivers’ availability. But we chose to start with a small feasibility study in ‘real real-life conditions’, in order to prepare for the enrollment in the THERAD study. Another limitation is that the use of a heteroevaluation scale could be criticized. Indeed, the evaluator is the patient’s caregiver and therefore presents a subjective view while their representations might influence the assessment. It has been proven that there could be differences on QOL ratings between patients, caregivers, and theoretical models [50, 51]. Caregivers consistently rate the patient’s QOL lower [52]. However, we chose proxy rating of the QOL-AD scale for several reasons. First, in our routine practice we found that it was difficult to estimate the patient’s QOL with self-rating. The patient’s ability to identify changes or to make choices among options in a scale is affected by lack of insight, due to anosognosia [50, 53]. Then, with increasing severity of the disease patients must receive an important help from the rater to complete the scale, which can introduce a real bias, the experimenter’s bias (including social desirability). We tried to limit this bias by using a method of collection of data that do not require presence involvement of an

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interviewer. Indeed, the participants were explained how to answer the questions by a well-trained interviewer, but let alone to complete the scales. Moreover, the intervention in itself was designed to improve caregivers’ knowledge and to modify their attitude or behavior, but not to specifically decrease their burden or improve their mood, factors that have been shown to influence the rating of the QOL by caregivers [54–58]. Furthermore, psychosocial interventions have shown mild to modest efficacy in mitigating caregiver burden in high-quality meta-analyses. Many studies showed improvements in caregiver burden-associated symptoms (e.g., mood, coping, self-efficacy) even when caregiver burden itself was minimally improved [59]. We thus hypothesized that the potential effect of our intervention would not be linked to a lesser caregiver’s burden which might modify his/her assessment of the patient’s QOL, but to an improvement in the patient’s QOL itself. Acknowledging the problem of potential bias of proxy reports, we decided to add self-rating methods as a secondary outcome in the RCT, because it has been demonstrated that self-rating and caregiver’s ratings are complementary and should be treated separately [60, 61].

[2]

[3]

[4]

[5]

[6]

[7]

CONCLUSION [8]

This study, despite its small size, has demonstrated a positive impact of a therapeutic educational program designed for patient/caregiver dyads on AD patients’ quality of life. Our results encouraged us to develop a monocentric, randomized, single-blind, controlled intervention trial. This trial, the THERAD study, is in its inclusion period and has already enrolled 110 dyads. The results will be available in 2015. If the efficacy of such an approach is proven, then it will be important to implement therapeutic educational programs in the care plan of every AD-affected patient.

[9]

[10]

[11]

[12]

ACKNOWLEDGMENTS

[13]

Thanks to Marie-Pierre Bautrait, Corine Jolimay, and Antoine Piau. Authors’ disclosures available online (http://www.jalz.com/disclosures/view.php?id=2362).

[14]

[15]

REFERENCES [1]

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