Protocols Randomized controlled trial of a multipronged intervention to improve blood pressure control among stroke survivors in Nigeria Mayowa O. Owolabi1, Rufus O. Akinyemi2, Mulugeta Gebregziabher3, Olanrewaju Olaniyan4, Babatunde L. Salako1, Oyedunni Arulogun5, and Bruce Ovbiagele6 Rationale Stroke is the second-leading cause of death in lowand middle-income countries, but use of evidence-based therapies for stroke prevention in such countries, especially those in Africa, is extremely poor. This study is designed to enhance the implementation and sustainability of secondary strokepreventive services following hospital discharge. Aim/Hypothesis The primary study aim is to test whether a Chronic Care Model-based initiative entitled the Tailored Hospital-based Risk reduction to Impede Vascular Events after Stroke (THRIVES) significantly improves blood pressure control after stroke. Design This prospective triple-blind randomized controlled trial will include a cohort of 400 patients with a recent stroke discharged from four medical care facilities in Nigeria. The culturally sensitive, system-appropriate intervention comprises patient report cards, phone text messaging, an educational video, and coordination of posthospitalization care. Study Outcomes The primary outcome is improvement of blood pressure control. Secondary endpoints include control of other stroke risk factors, medication adherence, functional status, and quality of life. We will also perform a cost analysis of THRIVES from the viewpoint of government policy-makers. Discussion We anticipate that a successful intervention will serve as a scalable model of effective postdischarge chronic blood pressure management for stroke in sub-Saharan Africa and possibly for other symptomatic cardiovascular disease entities in the region. Key words: Chronic Care Model, hypertension, low- and middle- income countries, patient report card, secondary prevention, stroke
Correspondence: Bruce Ovbiagele, Department of Neurosciences, Medical University of South Carolina, 96 Jonathan Lucas Street, CSB 301, MSC 606, Charleston, SC 29425, USA. Email: [email protected] 1 Department of Medicine, University of Ibadan, Ibadan, Nigeria 2 Department of Medicine, Federal Medical Centre, Abeokuta, Nigeria 3 Division of Biostatistics and Epidemiology, Medical University of South Carolina, Charleston, SC, USA 4 Department of Economics, University of Ibadan, Ibadan, Nigeria 5 Department of Health Promotion and Education, University of Ibadan, Ibadan, Nigeria 6 Department of Neurosciences, Medical University of South Carolina, Charleston, SC, USA Received: 21 December 2013; Accepted: 20 May 2014; Published online 18 July 2014 Conflict of interest: None declared. Trial registration: URL: http://www.clinicaltrials.gov; unique identifier: NCT01900756 Funding: National Institute of Neurological Disorders and Stroke – Award Number U01 NS079179. DOI: 10.1111/ijs.12331 © 2014 World Stroke Organization
Introduction Over the last four decades, the rate of stroke occurrence in lowand middle-income countries (LMICs) has approximately doubled, whereas it has decreased in high-income countries (HICs) (1). Moreover, rates of disability and mortality arising from stroke are at least 10 times greater in LMICs compared with HICs (1,2). Most of these LMICs are in Africa, where the burden of stroke is likely to continue to increase over the next few decades owing to ongoing epidemiological transition (3). The stroke quadrangle, of which prevention is a key component, has been proposed to combat this escalating burden (4). Use of evidence-based therapies for the prevention of stroke in patients receiving conventional care remains inadequate, despite the availability of data that support their use (5). Longitudinal epidemiologic studies have identified a number of modifiable stroke risk factors (6) that, if properly modified or controlled, could substantially lessen the burden of stroke. The most preeminent of these is hypertension, a condition that strongly confers elevated risk for both primary and recurrent stroke (7,8). In Nigeria, the most populous African country, up to 36·6% of adults and up to 98% of stroke patients are hypertensive (9,10). Therefore, optimization of blood pressure (BP) reduction needs to be at the center of any serious effort to lessen the burden of stroke in sub-Saharan Africa. Systematic reviews and large cohort studies have shown poor utilization rates (11,12) for a variety of medical and lifestyle modification measures aimed at controlling blood pressure in patients with stroke or other chronic diseases. Successful programs developed to promote secondary stroke prevention strategies tend to incorporate elements of the Chronic Care Model (CCM) into their design and algorithms (13–16). CCM comprises 6 major components: self-management support, clinical information systems, delivery system redesign, decision support, healthcare organization, and community resources (13–16). An example of such a program is PROTECT (Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment), whose important components included the use of a ‘report card’ tailored to individual patients’ risk factors and aimed at improving patient self-management (14–16). PROTECT was associated with high rates of postdischarge compliance with treatment, lifestyle modification, and target biomarker goals, as well as a substantially lower early vascular event rate in the first three-months after index stroke (14–16). The primary study aim is to test whether a CCM-based initiative entitled the Tailored Hospital-Based Risk reduction to Impede Vascular Events after Stroke (THRIVES) significantly Vol 9, December 2014, 1109–1116
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improves blood pressure control after stroke. We will also test whether the multipronged intervention improves control of other stroke risk factors, functional status, and quality of life. We will perform a cost analysis of THRIVES from the viewpoint of government policymakers.
Methods Design This prospective randomized controlled trial will include a cohort of 400 patients with a recent stroke discharged from four medical care facilities in Nigeria. Nigeria provides an ideal setting for this initiative to develop and test the efficacy of a tool to reduce BP levels among stroke survivors in an LMIC. The designation of its economy as a middle-income economy by the World Bank could mean results of studies performed here might be more readily generalizable to other LMICs. The study will be conducted at four hospitals of different types, chosen to capture key aspects of the diverse population of southwestern Nigeria. The University College Hospital Ibadan, the first teaching hospital in Nigeria, receives referrals from all over Nigeria and sub-Saharan Africa; Blossom Centre for NeuroRehabilitation, Ibadan, a rehabilitation referral center, provides physical therapy, occupational therapy, and speech/cognitive therapy facilities for neurologically impaired patients; Federal Medical Centre, Abeokuta, a 250–bed regional tertiary center, receives patients from neighbouring counties and states; and Sacred Heart Hospital, Abeokuta, a Catholic missionary hospital,
provides secondary medical care to an impoverished community in southwest Nigeria. Ethical approval Ethical approval has been obtained from the institutional review boards of the Medical University of South Carolina; the University of California at San Diego; the University of Ibadan/ University College Hospital (also covering WFNR-Blossom Specialist Medical Centre), Ibadan; the Federal Medical Centre, Abeokuta; and Sacred Heart Hospital, Abeokuta. Informed consent will be obtained from all participants. The informed consent form will be translated into the local language and administered to the patients. Patient population Patients aged ≥ 18 years with stroke onset within one-year before the study and with access to a mobile phone will be included. We will exclude those with severe aphasia or difficulty with communication and those with any medical condition that would limit participation in follow-up assessments, such as severe cognitive impairment/dementia (modified Community Screening Instrument for Dementia score ≤ 20) or severe global disability (modified Rankin Score ≥3). Consecutive eligible consenting stroke patients will be recruited from the inpatient and outpatient services of the four medical facilities. Randomization Once eligibility and consent are confirmed (Fig. 1), participants will be randomly assigned to THRIVES intervention vs. standard postdischarge management in a 1:1 allocation ratio, stratified by Recruit 400 eligible cases
Baseline assessments
Randomization
THRIVES Intervention (n = 200)
Usual care (n = 200)
Stroke clinic visit (report card/video) 1 month after randomization
Postclinic phone risk factor summary text
Assessments at 1 month Stroke clinic visit (report card/video) 3 months after randomization
Assessments at 3 months Stroke clinic visit (report card/video) 6 months after randomization
Assessments at 6 months Stroke clinic visit (report card/video) 9 months after randomization
Assessments at 12 months
Fig. 1 Flowchart displaying expected recruitment numbers, course of interventions, and assessment times.
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M. O. Owolabi et al. study site, stroke type (ischemic vs. hemorrhagic), and time from qualifying stroke occurrence (less than two-weeks vs. more than two-weeks). The randomization scheme will be developed and maintained by the study biostatistician centrally at the Medical University of South Carolina. Interventions Experimental group The intervention proposed in this study will comprise the CCM components of delivery system redesign (increased follow-up visits, preappointment phone texts), self-management support (patient report card, postclinic follow-up phone texts, waiting room educational video), and clinical information systems (patient report card as part of medical chart, hospital registry). The intervention will last one-year after stroke onset and will consist of five parts. First, patients will receive a preappointment phone text asking them to arrive an hour early for their appointment. Second, while in the waiting room, the patients will be asked to watch a stroke awareness educational video containing dramatized stroke scenarios, educational messages, and questions on the material taught, with delayed responses. Content will be structured to be consistent with the content and sequence of material in checklist form on the patient report card. The video will run for 30–45 mins and be shown to the intervention patients at every clinic visit. Third, when the patient meets with the physician, the content of the video will be briefly discussed. The physician will then show the patient the customized report card and go over the patient’s current vs. optimal control of key stroke risk factors. Following the discussion, the patient or caregiver will sign the report card, and a copy will be given to the patient and another placed in the medical chart. If this is a return visit, progress since the last visit will be queried, and specific difficulties in optimizing risk factor control will be discussed with a plan of action. Patients will be asked to bring the updated cards back to subsequent THRIVES sessions. Fourth, at the end of THRIVES clinic, the physician who saw the patient will send a brief structured postclinic phone text to the patient’s mobile (cellular) phone emphasizing the areas requiring better risk factor control. Fifth, each patient will be tracked in an electronic outpatient stroke registry. The registry will contain data written on the report cards. It will also contain contact information so the patient can be sent care-coordination phone texts. We expect these interventions, as components of the CCM, to have a synergistic effect (17–21). Control group The control group will receive a standardized version of the usual and customary care delivered at each hospital. This usually consists of risk factor identification and control without the additional interventions to be introduced in this trial. We expect some variation in these practices between hospitals and have addressed this in the study design by stratifying randomization by recruiting hospital. At the outpatient clinics of all study sites, stroke patients are seen by doctors who measure their blood pressure and review © 2014 World Stroke Organization
Protocols their laboratory results (e.g., blood sugar and lipids). The respective medications are subsequently adjusted accordingly. At WFNR-Blossom Centre, in addition to the above, patients’ recovery is assessed and their rehabilitation plan (e.g., physiotherapy) is evaluated and adjusted if need be. The control subjects will also be provided with the name and contact information of a phone contact. To maximize retention, the phone contact will contact the participant by phone every two-months simply to remind them of study participation. The message will only remind the patient about study participation without reference to their risk factors, medication use, or lifestyle modification. Outcome measures Study outcome measures are listed in Tables 1 and 2.The primary outcome will be a significant reduction in systolic blood pressure (SBP) at one-year. SBP was specifically chosen given its relatively stronger relationship with vascular risk (vs. diastolic BP) and more reliable measurements (22,23). We will also evaluate whether the THRIVES intervention has other impacts, as listed in the aims. Baseline assessment Baseline sociodemographic and clinical data will be obtained from all patients using a standardized questionnaire. This will capture patients’ age, sex, marital status, household size, household income, proportion of expenditure on food, occupation, and level of education. We will obtain history of hypertension, diabetes mellitus, hyperlipidemia, heart disease, smoking, alcohol consumption, diet (food frequency questionnaire), physical activity (at work, leisure, time on foot, sedentary time), and medication use. Family history of diabetes, hypertension, cardiovascular disease, stroke, and coronary artery disease will be documented. Baseline clinical assessment will include stroke severity (National Institutes of Health Stroke Scale and Stroke Levity Scale), anthropometric measurements (weight, height, waist circumference, hip circumference), pulse rate, and blood pressure. Records on stroke type (by imaging) and relevant risk factors for stroke (including fasting blood sugar, lipid profile, electrocardiogram, carotid Doppler, and echocardiographic findings) will be noted. Outcome assessment Trained research coordinators (blinded assessors) who are blinded to the randomization arm (and with no contact with the THRIVES clinical team) will collect study outcomes in all enrollees. Assessments will be conducted in person at baseline, onemonth, three-months, six-months, and 12 months. At each in-person assessment, two BP measurements will be obtained and averaged from each subject with an Omron HEM-907XL26 blood pressure monitor (Omron, Kyoto, Japan) according to a standardized protocol provided by the manufacturer specifying the proper cuff size, cuff application, body position, and time intervals when taking a measurement. A large set of potential mediators of risk factor control will also be collected. Patients and families will be contacted annually to determine the occurrence and time of any vascular events. Medical records will be obtained where available for review and, if not confirmed by laboratory data, will be sent to a blinded adjudicator. The THRIVES task force will review the initiation and progress of the trial at regular intervals and Vol 9, December 2014, 1109–1116
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Table 1 Outcome measures Endpoint level
Endpoint name
Endpoint description
Primary Secondary
Systolic blood pressure (mmHg) Smoking status Body mass index (kg/m2) Waist circumference Diet
Mean change at 12 months No smoking activity beyond one-month of index stroke Mean change at 12 months Mean change at 12 months At least five servings of fruits and/or vegetables per day, at least two servings of fish per week, and at least one fiber-rich meal per day; less than one-third of daily intake attributable to fat; activity must have been performed for at least four-of-seven-days of the week, for at least eight-of-12 months beyond index event Walking, running, or swimming for 30 mins at least four-days per week or physical or occupational therapy of a similar duration and frequency; activity must have been performed for at least eight-of-12 months beyond index event Mean change in HRQOLISP-40 and modified Rankin scale Incident event Incident event Incident event Mean change in validated scales for various cognitive domains Mean change in validated scales for anxiety and depression Direct and associated costs of intervention minus associated costs of usual care at 12 months
Physical activity
Tertiary
Quaternary
Quality of life/functional status Stroke Myocardial infarction Vascular death Cognitive impairment Anxiety, depression Costs
HRQOLISP, Health-Related Quality of Life in Stroke Patients.
Table 2 Timing of assessments and outcome instruments
Clinical instruments/measurements
Approximate duration of patient assessment
Baseline
1 month
3 months
6 months
12 months
Systolic blood pressure Body mass index Proportion not smoking* Proportion adherent to diet† Proportion adherent to exercise‡ HRQOLISP-40 Disability (modified Rankin Scale) Vascular event occurrence Assessment of cognitive function, anxiety and depression§¶
Correspondence: Bruce Ovbiagele, Department of Neurosciences, Medical University of South Carolina, 96 Jonathan Lucas Street, CSB 301, MSC 606, Charleston, SC 29425, USA. Email: [email protected] 1 Department of Medicine, University of Ibadan, Ibadan, Nigeria 2 Department of Medicine, Federal Medical Centre, Abeokuta, Nigeria 3 Division of Biostatistics and Epidemiology, Medical University of South Carolina, Charleston, SC, USA 4 Department of Economics, University of Ibadan, Ibadan, Nigeria 5 Department of Health Promotion and Education, University of Ibadan, Ibadan, Nigeria 6 Department of Neurosciences, Medical University of South Carolina, Charleston, SC, USA Received: 21 December 2013; Accepted: 20 May 2014; Published online 18 July 2014 Conflict of interest: None declared. Trial registration: URL: http://www.clinicaltrials.gov; unique identifier: NCT01900756 Funding: National Institute of Neurological Disorders and Stroke – Award Number U01 NS079179. DOI: 10.1111/ijs.12331 © 2014 World Stroke Organization
Introduction Over the last four decades, the rate of stroke occurrence in lowand middle-income countries (LMICs) has approximately doubled, whereas it has decreased in high-income countries (HICs) (1). Moreover, rates of disability and mortality arising from stroke are at least 10 times greater in LMICs compared with HICs (1,2). Most of these LMICs are in Africa, where the burden of stroke is likely to continue to increase over the next few decades owing to ongoing epidemiological transition (3). The stroke quadrangle, of which prevention is a key component, has been proposed to combat this escalating burden (4). Use of evidence-based therapies for the prevention of stroke in patients receiving conventional care remains inadequate, despite the availability of data that support their use (5). Longitudinal epidemiologic studies have identified a number of modifiable stroke risk factors (6) that, if properly modified or controlled, could substantially lessen the burden of stroke. The most preeminent of these is hypertension, a condition that strongly confers elevated risk for both primary and recurrent stroke (7,8). In Nigeria, the most populous African country, up to 36·6% of adults and up to 98% of stroke patients are hypertensive (9,10). Therefore, optimization of blood pressure (BP) reduction needs to be at the center of any serious effort to lessen the burden of stroke in sub-Saharan Africa. Systematic reviews and large cohort studies have shown poor utilization rates (11,12) for a variety of medical and lifestyle modification measures aimed at controlling blood pressure in patients with stroke or other chronic diseases. Successful programs developed to promote secondary stroke prevention strategies tend to incorporate elements of the Chronic Care Model (CCM) into their design and algorithms (13–16). CCM comprises 6 major components: self-management support, clinical information systems, delivery system redesign, decision support, healthcare organization, and community resources (13–16). An example of such a program is PROTECT (Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment), whose important components included the use of a ‘report card’ tailored to individual patients’ risk factors and aimed at improving patient self-management (14–16). PROTECT was associated with high rates of postdischarge compliance with treatment, lifestyle modification, and target biomarker goals, as well as a substantially lower early vascular event rate in the first three-months after index stroke (14–16). The primary study aim is to test whether a CCM-based initiative entitled the Tailored Hospital-Based Risk reduction to Impede Vascular Events after Stroke (THRIVES) significantly Vol 9, December 2014, 1109–1116
1109
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improves blood pressure control after stroke. We will also test whether the multipronged intervention improves control of other stroke risk factors, functional status, and quality of life. We will perform a cost analysis of THRIVES from the viewpoint of government policymakers.
Methods Design This prospective randomized controlled trial will include a cohort of 400 patients with a recent stroke discharged from four medical care facilities in Nigeria. Nigeria provides an ideal setting for this initiative to develop and test the efficacy of a tool to reduce BP levels among stroke survivors in an LMIC. The designation of its economy as a middle-income economy by the World Bank could mean results of studies performed here might be more readily generalizable to other LMICs. The study will be conducted at four hospitals of different types, chosen to capture key aspects of the diverse population of southwestern Nigeria. The University College Hospital Ibadan, the first teaching hospital in Nigeria, receives referrals from all over Nigeria and sub-Saharan Africa; Blossom Centre for NeuroRehabilitation, Ibadan, a rehabilitation referral center, provides physical therapy, occupational therapy, and speech/cognitive therapy facilities for neurologically impaired patients; Federal Medical Centre, Abeokuta, a 250–bed regional tertiary center, receives patients from neighbouring counties and states; and Sacred Heart Hospital, Abeokuta, a Catholic missionary hospital,
provides secondary medical care to an impoverished community in southwest Nigeria. Ethical approval Ethical approval has been obtained from the institutional review boards of the Medical University of South Carolina; the University of California at San Diego; the University of Ibadan/ University College Hospital (also covering WFNR-Blossom Specialist Medical Centre), Ibadan; the Federal Medical Centre, Abeokuta; and Sacred Heart Hospital, Abeokuta. Informed consent will be obtained from all participants. The informed consent form will be translated into the local language and administered to the patients. Patient population Patients aged ≥ 18 years with stroke onset within one-year before the study and with access to a mobile phone will be included. We will exclude those with severe aphasia or difficulty with communication and those with any medical condition that would limit participation in follow-up assessments, such as severe cognitive impairment/dementia (modified Community Screening Instrument for Dementia score ≤ 20) or severe global disability (modified Rankin Score ≥3). Consecutive eligible consenting stroke patients will be recruited from the inpatient and outpatient services of the four medical facilities. Randomization Once eligibility and consent are confirmed (Fig. 1), participants will be randomly assigned to THRIVES intervention vs. standard postdischarge management in a 1:1 allocation ratio, stratified by Recruit 400 eligible cases
Baseline assessments
Randomization
THRIVES Intervention (n = 200)
Usual care (n = 200)
Stroke clinic visit (report card/video) 1 month after randomization
Postclinic phone risk factor summary text
Assessments at 1 month Stroke clinic visit (report card/video) 3 months after randomization
Assessments at 3 months Stroke clinic visit (report card/video) 6 months after randomization
Assessments at 6 months Stroke clinic visit (report card/video) 9 months after randomization
Assessments at 12 months
Fig. 1 Flowchart displaying expected recruitment numbers, course of interventions, and assessment times.
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M. O. Owolabi et al. study site, stroke type (ischemic vs. hemorrhagic), and time from qualifying stroke occurrence (less than two-weeks vs. more than two-weeks). The randomization scheme will be developed and maintained by the study biostatistician centrally at the Medical University of South Carolina. Interventions Experimental group The intervention proposed in this study will comprise the CCM components of delivery system redesign (increased follow-up visits, preappointment phone texts), self-management support (patient report card, postclinic follow-up phone texts, waiting room educational video), and clinical information systems (patient report card as part of medical chart, hospital registry). The intervention will last one-year after stroke onset and will consist of five parts. First, patients will receive a preappointment phone text asking them to arrive an hour early for their appointment. Second, while in the waiting room, the patients will be asked to watch a stroke awareness educational video containing dramatized stroke scenarios, educational messages, and questions on the material taught, with delayed responses. Content will be structured to be consistent with the content and sequence of material in checklist form on the patient report card. The video will run for 30–45 mins and be shown to the intervention patients at every clinic visit. Third, when the patient meets with the physician, the content of the video will be briefly discussed. The physician will then show the patient the customized report card and go over the patient’s current vs. optimal control of key stroke risk factors. Following the discussion, the patient or caregiver will sign the report card, and a copy will be given to the patient and another placed in the medical chart. If this is a return visit, progress since the last visit will be queried, and specific difficulties in optimizing risk factor control will be discussed with a plan of action. Patients will be asked to bring the updated cards back to subsequent THRIVES sessions. Fourth, at the end of THRIVES clinic, the physician who saw the patient will send a brief structured postclinic phone text to the patient’s mobile (cellular) phone emphasizing the areas requiring better risk factor control. Fifth, each patient will be tracked in an electronic outpatient stroke registry. The registry will contain data written on the report cards. It will also contain contact information so the patient can be sent care-coordination phone texts. We expect these interventions, as components of the CCM, to have a synergistic effect (17–21). Control group The control group will receive a standardized version of the usual and customary care delivered at each hospital. This usually consists of risk factor identification and control without the additional interventions to be introduced in this trial. We expect some variation in these practices between hospitals and have addressed this in the study design by stratifying randomization by recruiting hospital. At the outpatient clinics of all study sites, stroke patients are seen by doctors who measure their blood pressure and review © 2014 World Stroke Organization
Protocols their laboratory results (e.g., blood sugar and lipids). The respective medications are subsequently adjusted accordingly. At WFNR-Blossom Centre, in addition to the above, patients’ recovery is assessed and their rehabilitation plan (e.g., physiotherapy) is evaluated and adjusted if need be. The control subjects will also be provided with the name and contact information of a phone contact. To maximize retention, the phone contact will contact the participant by phone every two-months simply to remind them of study participation. The message will only remind the patient about study participation without reference to their risk factors, medication use, or lifestyle modification. Outcome measures Study outcome measures are listed in Tables 1 and 2.The primary outcome will be a significant reduction in systolic blood pressure (SBP) at one-year. SBP was specifically chosen given its relatively stronger relationship with vascular risk (vs. diastolic BP) and more reliable measurements (22,23). We will also evaluate whether the THRIVES intervention has other impacts, as listed in the aims. Baseline assessment Baseline sociodemographic and clinical data will be obtained from all patients using a standardized questionnaire. This will capture patients’ age, sex, marital status, household size, household income, proportion of expenditure on food, occupation, and level of education. We will obtain history of hypertension, diabetes mellitus, hyperlipidemia, heart disease, smoking, alcohol consumption, diet (food frequency questionnaire), physical activity (at work, leisure, time on foot, sedentary time), and medication use. Family history of diabetes, hypertension, cardiovascular disease, stroke, and coronary artery disease will be documented. Baseline clinical assessment will include stroke severity (National Institutes of Health Stroke Scale and Stroke Levity Scale), anthropometric measurements (weight, height, waist circumference, hip circumference), pulse rate, and blood pressure. Records on stroke type (by imaging) and relevant risk factors for stroke (including fasting blood sugar, lipid profile, electrocardiogram, carotid Doppler, and echocardiographic findings) will be noted. Outcome assessment Trained research coordinators (blinded assessors) who are blinded to the randomization arm (and with no contact with the THRIVES clinical team) will collect study outcomes in all enrollees. Assessments will be conducted in person at baseline, onemonth, three-months, six-months, and 12 months. At each in-person assessment, two BP measurements will be obtained and averaged from each subject with an Omron HEM-907XL26 blood pressure monitor (Omron, Kyoto, Japan) according to a standardized protocol provided by the manufacturer specifying the proper cuff size, cuff application, body position, and time intervals when taking a measurement. A large set of potential mediators of risk factor control will also be collected. Patients and families will be contacted annually to determine the occurrence and time of any vascular events. Medical records will be obtained where available for review and, if not confirmed by laboratory data, will be sent to a blinded adjudicator. The THRIVES task force will review the initiation and progress of the trial at regular intervals and Vol 9, December 2014, 1109–1116
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Table 1 Outcome measures Endpoint level
Endpoint name
Endpoint description
Primary Secondary
Systolic blood pressure (mmHg) Smoking status Body mass index (kg/m2) Waist circumference Diet
Mean change at 12 months No smoking activity beyond one-month of index stroke Mean change at 12 months Mean change at 12 months At least five servings of fruits and/or vegetables per day, at least two servings of fish per week, and at least one fiber-rich meal per day; less than one-third of daily intake attributable to fat; activity must have been performed for at least four-of-seven-days of the week, for at least eight-of-12 months beyond index event Walking, running, or swimming for 30 mins at least four-days per week or physical or occupational therapy of a similar duration and frequency; activity must have been performed for at least eight-of-12 months beyond index event Mean change in HRQOLISP-40 and modified Rankin scale Incident event Incident event Incident event Mean change in validated scales for various cognitive domains Mean change in validated scales for anxiety and depression Direct and associated costs of intervention minus associated costs of usual care at 12 months
Physical activity
Tertiary
Quaternary
Quality of life/functional status Stroke Myocardial infarction Vascular death Cognitive impairment Anxiety, depression Costs
HRQOLISP, Health-Related Quality of Life in Stroke Patients.
Table 2 Timing of assessments and outcome instruments
Clinical instruments/measurements
Approximate duration of patient assessment
Baseline
1 month
3 months
6 months
12 months
Systolic blood pressure Body mass index Proportion not smoking* Proportion adherent to diet† Proportion adherent to exercise‡ HRQOLISP-40 Disability (modified Rankin Scale) Vascular event occurrence Assessment of cognitive function, anxiety and depression§¶
