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Healthy Lifestyles After Stroke (Stroke Coach)

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ClinicalTrials.gov Identifier: NCT02207023
Recruitment Status : Recruiting
First Posted : August 1, 2014
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Janice Eng, 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.

Condition or disease Intervention/treatment Phase
Stroke Apoplexy Cerebral Stroke Cerebrovascular Accident Cerebrovascular Accident, Acute Cerebrovascular Apoplexy Cerebrovascular Stroke CVA Stroke, Acute Vascular Accident, Brain Behavioral: Healthy Lifestyle Training Program Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 124 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 : October 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

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.




Primary Outcome Measures :
  1. Changes from baseline in global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) at 6 months and 12 months. [ Time Frame: At baseline (0 months), end of program (6 months), and 6 months after the program ends (12 months from baseline) for a total of 3 assessments per subject. ]

Secondary Outcome Measures :
  1. Daily walking physical activity [ Time Frame: At baseline (0 months), end of program (6 months), and 6 months after the program ends (12 months from baseline) for a total of 3 assessments per subject. ]
    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) [ Time Frame: At baseline (0 months), end of program (6 months), and 6 months after the program ends (12 months from baseline) for a total of 3 assessments per subject. ]
    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 [ Time Frame: At baseline (0 months), end of program (6 months), and 6 months after the program ends (12 months from baseline) for a total of 3 assessments per subject. ]
  4. Depressive symptoms (20-item Centre for Epidemiological Studies-Depression [CES-D] Scale) [ Time Frame: At baseline (0 months), end of program (6 months), and 6 months after the program ends (12 months from baseline) for a total of 3 assessments per subject. ]
    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]) [ Time Frame: At baseline (0 months), end of program (6 months), and 6 months after the program ends (12 months from baseline) for a total of 3 assessments per subject. ]
    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). [ Time Frame: At baseline (0 months), end of program (6 months), and 6 months after the program ends (12 months from baseline) for a total of 3 assessments per subject. ]
  7. Body composition (Body Mass Index, waist circumference) [ Time Frame: At baseline (0 months), end of program (6 months), and 6 months after the program ends (12 months from baseline) for a total of 3 assessments per subject.post-stroke ]
  8. Health-related quality of life (SF-36) [ Time Frame: At baseline (0 months), end of program (6 months), and 6 months after the program ends (12 months from baseline) for a total of 3 assessments per subject. ]
  9. Health and Social Services Utilization (Health and Social Service Utilization Inventory) [ Time Frame: At baseline (0 months), end of program (6 months), and 6 months after the program ends (12 months from baseline) for a total of 3 assessments per subject. ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207023


Contacts
Contact: Chihya Hung, MSc 604-714-4117 Chihya.Hung@ubc.ca
Contact: Brodie Sakakibara, PhD 604-737-6310 brodie@alumni.ubc.ca

Locations
Canada, British Columbia
Royal Columbian Hospital Not yet recruiting
New Westminster, British Columbia, Canada, V3L 3W7
Contact: Brodie Sakakibara, PhD    604-737-6310    brodie@alumni.ubc.ca   
University Hospital of Northern BC Recruiting
Prince George, British Columbia, Canada, V2M 1S2
Contact: Brodie Sakakibara, PhD    604-737-6310    brodie@alumni.ubc.ca   
Surrey Memorial Hospital Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Brodie Sakakibara, PhD    604-737-6310    brodie@alumni.ubc.ca   
Holy Family Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5P 3L6
Contact: Brodie Sakakibara, PhD    604-737-6310    brodie@alumni.ubc.ca   
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Brodie Sakakibara, PhD    604-737-6310    brodie@alumni.ubc.ca   
GF Strong Rehabilitation Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Contact: Chihya J Hung, MScPT    604-714-4117    Chihya.Hung@ubc.ca   
Principal Investigator: Janice Eng, PhD         
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Brodie Sakakibara, PhD    604-737-6310    brodie@alumni.ubc.ca   
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

Responsible Party: Janice Eng, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02207023     History of Changes
Other Study ID Numbers: H13-03353
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Janice Eng, University of British Columbia:
Stroke
Telehealth
Rehabilitation
Stroke Coach
Randomized controlled trial
Lifestyle behaviours
Secondary prevention
Chronic disease self-management

Additional relevant MeSH terms:
Stroke
Chronic Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes