Healthy Lifestyles After Stroke - Stroke Coach

Not Applicable

Completed

• Conditions: Stroke, Acute; Cerebrovascular Accident; Cerebrovascular Accident, Acute; Cerebrovascular Stroke; CVA; Stroke; Cerebrovascular Apoplexy; Cerebral Stroke; Apoplexy; Vascular Accident, Brain
• Interventions: Behavioral: Healthy Lifestyle Training Program

• Registration Number: NCT02207023
• Lead Sponsor: University of British Columbia

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-01
• Study Start: 2014-10
• Status Verified: 2020-03
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Lifestyle Training Program	Healthy Lifestyle Training Program	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.

Primary Outcome Measures

Name	Time	Method
Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)	End of program (6 months)	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.

Secondary Outcome Measures

Name	Time	Method
Body composition (Body Mass Index, waist circumference)	End of program (6 months), and 6 months after the program ends (12 months from baseline)	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.
Dietary behavior (26 items SmartDiet Questionnaire)	End of program (6 months), and 6 months after the program ends (12 months from baseline)	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.
Depressive symptoms (20-item Centre for Epidemiological Studies-Depression [CES-D] Scale)	End of program (6 months), and 6 months after the program ends (12 months from baseline)	This scale assess the frequency with which participants experience depression symptoms, such as restless sleep, poor appetite, and feeling lonely, during the past week.
Daily walking physical activity	End of program (6 months), and 6 months after the program ends (12 months from baseline)	Study participants will wear the activity monitor over the 7 days following each assessment period (baseline, 6 months, 12 months)
Medication adherence (8-item Morisky Medication Adherence Scale)	End of program (6 months), and 6 months after the program ends (12 months from baseline)	The Morisky Medication Adherence Scale assesses habits in taking medication and barriers that may hinder medication adherence.
Health-related quality of life (SF-36)	End of program (6 months), and 6 months after the program ends (12 months from baseline)	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.
Cognition (Montreal Cognitive Assessment [MoCA])	End of program (6 months), and 6 months after the program ends (12 months from baseline)	The MoCA is a screening instrument to assess for cognitive impairment.
Cardiovascular risk factors (resting blood pressure, lipid, and glucose profiles, C-Reactive Protein, Homocysteine).	End of program (6 months), and 6 months after the program ends (12 months from baseline)	These risk factors will be assessed using hospital lab services.
Health and Social Services Utilization (Health and Social Service Utilization Inventory)	End of program (6 months), and 6 months after the program ends (12 months from baseline)	The Health and Social Services Utilization inventory collects data regarding health services used, medications, and out of pocket health costs.
Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)	6 months after the program ends (12 months from baseline)	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.

Trial Locations

Locations (7)

Holy Family Hospital; 🇨🇦 Vancouver, British Columbia, Canada

University Hospital of Northern BC; 🇨🇦 Prince George, British Columbia, Canada

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

GF Strong Rehabilitation Centre; 🇨🇦 Vancouver, British Columbia, Canada

Surrey Memorial Hospital; 🇨🇦 Surrey, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada