StrokeCoach: Healthy Lifestyles After Stroke - Stroke Coach

Sponsor
University of British Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT02207023
Collaborator
Canadian Institutes of Health Research (CIHR) (Other), Heart and Stroke Foundation of Canada (Other)
126
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66
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Study Details

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Telehealth Intervention to Promote Chronic Disease Management After Stroke: A Pilot Randomized Controlled Study
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Columbian Hospital New Westminster British Columbia Canada V3L 3W7
2 University Hospital of Northern BC Prince George British Columbia Canada V2M 1S2
3 Surrey Memorial Hospital Surrey British Columbia Canada V3V 1Z2
4 Holy Family Hospital Vancouver British Columbia Canada V5P 3L6
5 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
6 GF Strong Rehabilitation Centre Vancouver British Columbia Canada V5Z 2G9
7 St. Paul's Hospital Vancouver British Columbia Canada V6Z 1Y6

Sponsors and Collaborators

  • University of British Columbia
  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Canada

Investigators

  • Principal Investigator: Janice Eng, PhD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janice Eng, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier:
NCT02207023
Other Study ID Numbers:
  • H13-03353
First Posted:
Aug 1, 2014
Last Update Posted:
May 8, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Janice Eng, Principal Investigator, University of British Columbia
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 8, 2020