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Completed

NCT Number: NCT02207023

Healthy Lifestyles After Stroke - Stroke Coach

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.

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Key information

Conditions

Stroke Apoplexy Brain Diseases CVA Cardiovascular Diseases Central Nervous System Diseases Cerebral Stroke Cerebrovascular Accident Cerebrovascular Accident, Acute Cerebrovascular Apoplexy Cerebrovascular Disorders Cerebrovascular Stroke Nervous System Diseases Stroke, Acute Vascular Accident, Brain Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Columbian Hospital, New Westminster, British Columbia, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Lifestyle Training Program

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

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

Registry information

Official study title

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

Acronym: StrokeCoach

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2014
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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