Healthy Lifestyles After Stroke - Stroke Coach

Study Overview
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Brief Summary
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The purpose of this study is to examine the efficacy of a lifestyle modification telehealth program on health-related behaviours in community-dwelling individuals living with stroke.

Detailed Description
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Participants recruited in this study will be randomly assigned to either the Healthy Lifestyle Training Program, or Attention Control Memory Training Program. Individuals in the Healthy Lifestyle Training Program will each receive 7 lifestyle coaching telephone-sessions (30-60 minutes) with a trained lifestyle coach over a 6 month period. Individuals in the Memory Training Program will each receive 7 memory coaching telephone sessions (30-60 minutes) with a trained memory training coach over a 6 month period. 100 evaluable subjects will be recruited (124 to accommodate for 20% dropout).

Official Title
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A Telehealth Intervention to Promote Chronic Disease Management After Stroke: A Pilot Randomized Controlled Study

Conditions
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Stroke, Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy, Cerebrovascular Stroke, CVA, Stroke, Acute, Vascular Accident, Brain

Intervention / Treatment
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* Behavioral: Healthy Lifestyle Training Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has experienced a stroke in the last 12 months 50 years of age or older Living in the community with phone access Mild to moderate stroke severity (i.e., modified Rankin Scale score ranging from 1 to 4) Able to communicate in English Exclusion Criteria: Stroke of non-vascular origin Actively engaged in formal stroke rehabilitation services Uncontrolled arrhythmias Significant musculoskeletal or other neurological condition Severe aphasia or dysarthria Not medically stable Pain or co-morbidities which would preclude activity Living in long-term residential care Cognitive impairment, dependent in activities of daily living, and no caregiver participation

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Memory Training Program<br>Participants will participate in 7 memory training coaching sessions (two in the first month) over a 6 month period. The coaching sessions will be administered by phone. | |
| Experimental: Healthy Lifestyle Training Program<br>Participants will participate in 7 lifestyle coaching sessions (two in the first month) over a 6 month period. The coaching sessions will be administered by phone. | Behavioral: Healthy Lifestyle Training Program<br>* Study participants in the Healthy Lifestyle Training Program will each receive 7 lifestyle coaching telephone-sessions (30-60 minutes) with a trained lifestyle coach over a 6 month period. The lifestyle coaches will work on a 1:1 basis with each participant to encourage healthy lifestyles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) | The 52-item Health Promoting Lifestyle Profile II provides a composite score of lifestyle, in the areas of: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. | End of program (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily walking physical activity | Study participants will wear the activity monitor over the 7 days following each assessment period (baseline, 6 months, 12 months) | End of program (6 months), and 6 months after the program ends (12 months from baseline) | 
| Dietary behavior (26 items SmartDiet Questionnaire) | The SmartDiet Canadian Version Questionnaire was developed to assess fiber and fat intake. This questionnaire has 26 questions about diet and lifestyle. Most questions list foods in 3 or 4 categories according to fat or fiber content. | End of program (6 months), and 6 months after the program ends (12 months from baseline) | 
| Medication adherence (8-item Morisky Medication Adherence Scale) | The Morisky Medication Adherence Scale assesses habits in taking medication and barriers that may hinder medication adherence. | End of program (6 months), and 6 months after the program ends (12 months from baseline) | 
| Depressive symptoms (20-item Centre for Epidemiological Studies-Depression [CES-D] Scale) | This scale assess the frequency with which participants experience depression symptoms, such as restless sleep, poor appetite, and feeling lonely, during the past week. | End of program (6 months), and 6 months after the program ends (12 months from baseline) | 
| Cognition (Montreal Cognitive Assessment [MoCA]) | The MoCA is a screening instrument to assess for cognitive impairment. | End of program (6 months), and 6 months after the program ends (12 months from baseline) | 
| Cardiovascular risk factors (resting blood pressure, lipid, and glucose profiles, C-Reactive Protein, Homocysteine). | These risk factors will be assessed using hospital lab services. | End of program (6 months), and 6 months after the program ends (12 months from baseline) | 
| Body composition (Body Mass Index, waist circumference) | The Body Mass Index is a measure of body fat based on weight and height. Waist circumference will be measured using a tape measure around the waist at the height of the umbilicus. | End of program (6 months), and 6 months after the program ends (12 months from baseline) | 
| Health-related quality of life (SF-36) | The SF-36 is a generic health status measure that was designed to be applied to all health conditions and assess health concepts, which represent basic human values and are relevant to a person's functional status and well-being. | End of program (6 months), and 6 months after the program ends (12 months from baseline) | 
| Health and Social Services Utilization (Health and Social Service Utilization Inventory) | The Health and Social Services Utilization inventory collects data regarding health services used, medications, and out of pocket health costs. | End of program (6 months), and 6 months after the program ends (12 months from baseline) | 
| Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) | The 52-item Health Promoting Lifestyle Profile II provides a composite score of lifestyle, in the areas of: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. | 6 months after the program ends (12 months from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Telehealth, Rehabilitation, Stroke Coach, Randomized controlled trial, Lifestyle behaviours, Secondary prevention, Chronic disease self-management