StrokeStrokeCoachNCT02207023
Healthy Lifestyles After Stroke - Stroke Coach
A study testing Healthy Lifestyle Training Program in people with Stroke and Apoplexy, run by University of British Columbia at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Apoplexy, Cerebral Stroke
- What is being tested?
- Healthy Lifestyle Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 7 sitesCanada
- Study dates
- Oct 2014to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
University Hospital of Northern BC
Prince George, British Columbia, V2M 1S2
Surrey Memorial Hospital
Surrey, British Columbia, V3V 1Z2
Holy Family Hospital
Vancouver, British Columbia, V5P 3L6
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: 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.
Read the 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).
- Conditions
- Stroke, Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy
- Being tested
- Healthy Lifestyle Training Program
- Keywords
- Stroke, Telehealth, Rehabilitation, Stroke Coach, Randomized controlled trial, Lifestyle behaviours, Secondary prevention, Chronic disease self-management
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Lifestyle Training ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Memory Training Program | No intervention | 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. |
| Healthy Lifestyle Training Program | Experimental | 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. Receives: Behavioral: Healthy Lifestyle Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of program (6 months)
Secondary outcomes (10)
Daily walking physical activity
Study participants will wear the activity monitor over the 7 days following each assessment period (baseline, 6 months, 12 months)
Measured: End of program (6 months), and 6 months after the program ends (12 months from baseline)
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.
Measured: End of program (6 months), and 6 months after the program ends (12 months from baseline)
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.
Measured: 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)
This scale assess the frequency with which participants experience depression symptoms, such as restless sleep, poor appetite, and feeling lonely, during the past week.
Measured: End of program (6 months), and 6 months after the program ends (12 months from baseline)
Cognition (Montreal Cognitive Assessment [MoCA])
The MoCA is a screening instrument to assess for cognitive impairment.
Measured: 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).
These risk factors will be assessed using hospital lab services.
Measured: End of program (6 months), and 6 months after the program ends (12 months from baseline)
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.
Measured: End of program (6 months), and 6 months after the program ends (12 months from baseline)
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.
Measured: 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)
The Health and Social Services Utilization inventory collects data regarding health services used, medications, and out of pocket health costs.
Measured: 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)
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.
Measured: 6 months after the program ends (12 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startOct 2014
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Janice Eng, University of British Columbia
- Investigators
- Janice Eng, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207023
- Sponsor's protocol ID
- H13-03353
- Acronym
- StrokeCoach
- Status last verified
- Mar 2020
- First submitted
- 28 Jul 2014
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33949270Sakakibara 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.
PubMed 28869405
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telehealth Intervention to Promote Chronic Disease Management After Stroke: A Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02207023
- Acronym / sponsor ID
- StrokeCoach / H13-03353
- Conditions
- Stroke, Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy
- Keywords
- Stroke, Telehealth, Rehabilitation, Stroke Coach, Randomized controlled trial, Lifestyle behaviours, Secondary prevention, Chronic disease self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada
- Study start
- Oct 2014
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memory Training Program | No intervention | –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. |
| Healthy Lifestyle Training Program | Experimental | Behavioral: Healthy Lifestyle Training ProgramParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Stroke of non-vascular origin
- Actively engaged in formal stroke rehabilitation services
- Uncontrolled arrhythmias
- Significant musculoskeletal or other neurological condition
- Severe aphasia or dysarthria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Lifestyle Training ProgramStudy 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. | Behavioural | Healthy Lifestyle Training Program |
Primary outcome
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.
10 secondary outcomes
Daily walking physical activity
Time frame: 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)
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)
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)
Cognition (Montreal Cognitive Assessment [MoCA])
Time frame: 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)
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)
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)
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)
Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)
Time frame: 6 months after the program ends (12 months from baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Derived from this study: PubMed 33949270Sakakibara 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.
- Derived from this study: PubMed 28869405Sakakibara 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Eng, PhD principal investigator
University of British Columbia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyle Training Program in people with Stroke and Apoplexy, run by University of British Columbia at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) (time frame: End of program (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02207023, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.