Healthy Lifestyles After Stroke - Stroke Coach

Stroke Clinical Trial

— StrokeCoach  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207023
• Other study ID #: H13-03353
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apoplexy
• Cerebral Stroke
• Cerebrovascular Accident
• Cerebrovascular Accident, Acute
• Cerebrovascular Apoplexy
• Cerebrovascular Stroke
• CVA
• Stroke
• Stroke, Acute
• Vascular Accident, Brain

Intervention

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.

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	University Hospital of Northern BC	Prince George	British Columbia
Canada	Surrey Memorial Hospital	Surrey	British Columbia
Canada	GF Strong Rehabilitation Centre	Vancouver	British Columbia
Canada	Holy Family Hospital	Vancouver	British Columbia
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	End of program (6 months)
Secondary	Daily walking physical activity	Study participants will wear the activity monitor over the 7 days following each assessment period (baseline, 6 months, 12 months)	End of program (6 months), and 6 months after the program ends (12 months from baseline)
Secondary	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.	End of program (6 months), and 6 months after the program ends (12 months from baseline)
Secondary	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.	End of program (6 months), and 6 months after the program ends (12 months from baseline)
Secondary	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.	End of program (6 months), and 6 months after the program ends (12 months from baseline)
Secondary	Cognition (Montreal Cognitive Assessment [MoCA])	The MoCA is a screening instrument to assess for cognitive impairment.	End of program (6 months), and 6 months after the program ends (12 months from baseline)
Secondary	Cardiovascular risk factors (resting blood pressure, lipid, and glucose profiles, C-Reactive Protein, Homocysteine).	These risk factors will be assessed using hospital lab services.	End of program (6 months), and 6 months after the program ends (12 months from baseline)
Secondary	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.	End of program (6 months), and 6 months after the program ends (12 months from baseline)
Secondary	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.	End of program (6 months), and 6 months after the program ends (12 months from baseline)
Secondary	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.	End of program (6 months), and 6 months after the program ends (12 months from baseline)
Secondary	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.	6 months after the program ends (12 months from baseline)