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Healthy Lifestyles After Stroke - Stroke Coach (StrokeCoach)

Primary Purpose

Stroke, Apoplexy, Cerebral Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Healthy Lifestyle Training Program
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Stroke, Telehealth, Rehabilitation, Stroke Coach, Randomized controlled trial, Lifestyle behaviours, Secondary prevention, Chronic disease self-management

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Columbian Hospital
  • University Hospital of Northern BC
  • Surrey Memorial Hospital
  • Holy Family Hospital
  • Vancouver General Hospital
  • GF Strong Rehabilitation Centre
  • St. Paul's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Memory Training Program

Healthy Lifestyle Training Program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Daily walking physical activity
Study participants will wear the activity monitor over the 7 days following each assessment period (baseline, 6 months, 12 months)
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.
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.
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.
Cognition (Montreal Cognitive Assessment [MoCA])
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).
These risk factors will be assessed using hospital lab services.
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.
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.
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.
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.

Full Information

First Posted
July 28, 2014
Last Updated
May 5, 2020
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02207023
Brief Title
Healthy Lifestyles After Stroke - Stroke Coach
Acronym
StrokeCoach
Official Title
A Telehealth Intervention to Promote Chronic Disease Management After Stroke: A Pilot Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy, Cerebrovascular Stroke, CVA, Stroke, Acute, Vascular Accident, Brain
Keywords
Stroke, Telehealth, Rehabilitation, Stroke Coach, Randomized controlled trial, Lifestyle behaviours, Secondary prevention, Chronic disease self-management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memory Training Program
Arm Type
No Intervention
Arm Description
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.
Arm Title
Healthy Lifestyle Training Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Lifestyle Training Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)
Description
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.
Time Frame
End of program (6 months)
Secondary Outcome Measure Information:
Title
Daily walking physical activity
Description
Study participants will wear the activity monitor over the 7 days following each assessment period (baseline, 6 months, 12 months)
Time Frame
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Title
Dietary behavior (26 items SmartDiet Questionnaire)
Description
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.
Time Frame
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Title
Medication adherence (8-item Morisky Medication Adherence Scale)
Description
The Morisky Medication Adherence Scale assesses habits in taking medication and barriers that may hinder medication adherence.
Time Frame
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Title
Depressive symptoms (20-item Centre for Epidemiological Studies-Depression [CES-D] Scale)
Description
This scale assess the frequency with which participants experience depression symptoms, such as restless sleep, poor appetite, and feeling lonely, during the past week.
Time Frame
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Title
Cognition (Montreal Cognitive Assessment [MoCA])
Description
The MoCA is a screening instrument to assess for cognitive impairment.
Time Frame
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Title
Cardiovascular risk factors (resting blood pressure, lipid, and glucose profiles, C-Reactive Protein, Homocysteine).
Description
These risk factors will be assessed using hospital lab services.
Time Frame
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Title
Body composition (Body Mass Index, waist circumference)
Description
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.
Time Frame
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Title
Health-related quality of life (SF-36)
Description
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.
Time Frame
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Title
Health and Social Services Utilization (Health and Social Service Utilization Inventory)
Description
The Health and Social Services Utilization inventory collects data regarding health services used, medications, and out of pocket health costs.
Time Frame
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Title
Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)
Description
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.
Time Frame
6 months after the program ends (12 months from baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Eng, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
University Hospital of Northern BC
City
Prince George
State/Province
British Columbia
ZIP/Postal Code
V2M 1S2
Country
Canada
Facility Name
Surrey Memorial Hospital
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
Holy Family Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5P 3L6
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
GF Strong Rehabilitation Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33949270
Citation
Sakakibara BM, Lear SA, Barr SI, Goldsmith CH, Schneeberg A, Silverberg ND, Yao J, Eng JJ. Telehealth coaching to improve self-management for secondary prevention after stroke: A randomized controlled trial of Stroke Coach. Int J Stroke. 2022 Apr;17(4):455-464. doi: 10.1177/17474930211017699. Epub 2021 May 27.
Results Reference
derived
PubMed Identifier
28869405
Citation
Sakakibara BM, Lear SA, Barr SI, Benavente O, Goldsmith CH, Silverberg ND, Yao J, Eng JJ. A telehealth intervention to promote healthy lifestyles after stroke: The Stroke Coach protocol. Int J Stroke. 2018 Feb;13(2):217-222. doi: 10.1177/1747493017729266. Epub 2017 Sep 4.
Results Reference
derived

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Healthy Lifestyles After Stroke - Stroke Coach

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