Clinical trial NCT02207023: Healthy Lifestyles After Stroke - Stroke Coach
Official title: A Telehealth Intervention to Promote Chronic Disease Management After Stroke: A Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Apoplexy
Cerebral Stroke
Cerebrovascular Accident
Cerebrovascular Accident, Acute
Cerebrovascular Apoplexy
Cerebrovascular Stroke
CVA
Stroke, Acute
Vascular Accident, Brain
Keywords: Stroke
Telehealth
Rehabilitation
Stroke Coach
Randomized controlled trial
Lifestyle behaviours
Secondary prevention
Chronic disease self-management
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Heart and Stroke Foundation of Canada
First posted: 2014-08-01
Enrollment: 126
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)
timeFrame: End of program (6 months)
Secondary outcomes:
measure: Daily walking physical activity
timeFrame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
measure: Dietary behavior (26 items SmartDiet Questionnaire)
timeFrame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
measure: Medication adherence (8-item Morisky Medication Adherence Scale)
timeFrame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
measure: Depressive symptoms (20-item Centre for Epidemiological Studies-Depression [CES-D] Scale)
timeFrame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
measure: Cognition (Montreal Cognitive Assessment [MoCA])
timeFrame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
measure: Cardiovascular risk factors (resting blood pressure, lipid, and glucose profiles, C-Reactive Protein, Homocysteine).
timeFrame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
measure: Body composition (Body Mass Index, waist circumference)
timeFrame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
measure: Health-related quality of life (SF-36)
timeFrame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
measure: Health and Social Services Utilization (Health and Social Service Utilization Inventory)
timeFrame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
measure: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)
timeFrame: 6 months after the program ends (12 months from baseline)
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Prince George
country: Canada
facility: University Hospital of Northern BC
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Holy Family Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Janice Eng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sakakibara 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.