Healthy Lifestyles After Stroke - Stroke Coach (StrokeCoach)

May 5, 2020 updated by: Janice Eng, University of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W7
        • Royal Columbian Hospital
      • Prince George, British Columbia, Canada, V2M 1S2
        • University Hospital of Northern BC
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Surrey Memorial Hospital
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V5Z 2G9
        • GF Strong Rehabilitation Centre
      • Vancouver, British Columbia, Canada, V5P 3L6
        • Holy Family Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Memory Training Program
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)
Time Frame: 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.
End of program (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily walking physical activity
Time Frame: 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)
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Dietary behavior (26 items SmartDiet Questionnaire)
Time Frame: 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.
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Medication adherence (8-item Morisky Medication Adherence Scale)
Time Frame: 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.
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)
Time Frame: 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.
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Cognition (Montreal Cognitive Assessment [MoCA])
Time Frame: 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.
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).
Time Frame: 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.
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Body composition (Body Mass Index, waist circumference)
Time Frame: 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.
End of program (6 months), and 6 months after the program ends (12 months from baseline)
Health-related quality of life (SF-36)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
6 months after the program ends (12 months from baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-03353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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