Coaching Intervention for Caregivers of Persons With Stroke

Study Overview
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Brief Summary
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Caregivers of people with stroke experience strain that can reduce their quality of life. Caregivers are routinely engaged during hospital discharge for education and training related to the person with stroke. However, the critical period after stroke survivor's discharge is largely unsupported for the caregiver. This proposed study is a randomized controlled trial that will provide post-discharge support for caregivers using a health coaching program as compared to usual care and examine its effect of caregivers and people with stroke.

Detailed Description
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Caregiver strain reduces quality of life and can increase the chance of unplanned hospital readmission for the person with stroke. Caregivers are routinely engaged during hospital discharge for education and training. However, the critical period after discharge is largely unsupported. The proposed research will integrate occupational therapy and telehealth to provide a post-discharge, caregiver-focused program, the Health Coaching-in-Context that consists of up to 10 sessions, arranged once-a-week or multiple times a week based on convenience of scheduling for up to 10 weeks. The program targets improved caregiver health and reduction in readmissions for stroke survivor. The study aims to examine the effects of the coaching program for caregivers as compared to usual care and evaluate the feasibility of study design. A pilot randomized controlled trial will be conducted with two parallel groups, Health Coaching-in-Context and usual care. A sample of up to 40 pairs, including up to 40 stroke survivors and their respective 40 caregivers will be recruited from University hospitals and randomly assigned after consenting. The occupational therapist, unaware of the group assignment, will administer assessments before and after the intervention, and at 4-week follow-up. Data will be collected on general information, readmissions, performance, self-efficacy, and quality of life.

Official Title
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Coaching Intervention for Caregivers of Persons With Stroke

Conditions
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Stroke, Acute, Caregiver Stress Syndrome, Caregiver Burnout

Intervention / Treatment
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* Behavioral: Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Survivor criteria: First-time stroke, discharged from hospital within the past 30 days. Caregiver criteria: Informal caregiver primarily responsible for care (family member, friend, or partner), may or may not live in the same household. Passes cognition screen, willing to use teleconference using phone, tablet, or computer. Both: 18 to 80 years of age, understand and speak English Exclusion Criteria: Children 81 years of age or older Unable to understand and speak English Does not provide consent Caregiver does not pass cognition screen

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind randomized controlled trial design with two parallel groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coaching<br>Health Coaching-in-Context includes coaching by trained coaches up to 10 sessions over teleconference. | Behavioral: Coaching<br>* Health Coaching-in-Context that consists of up to 10 sessions, arranged once-a-week or multiple times a week based on convenience of scheduling for up to 10 weeks. The program targets improved caregiver health through occupational therapy coaching.<br>* Other names: Health Coaching in Context;|
| No Intervention: Usual Care<br>The usual care group does not get any intervention but continues with any of their usual activities that would otherwise would have been provided to them. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure | Measure of performance and satisfaction with performance of daily tasks. Each domain score is out of 10, minimum is 1, and higher scores are better. | Week 1 | 
| Canadian Occupational Performance Measure | Measure of performance and satisfaction with performance of daily tasks.Each domain score is out of 10, minimum is 1, and higher scores are better. | Week 12 | 
| Canadian Occupational Performance Measure | Measure of performance and satisfaction with performance of daily tasks. Each domain score is out of 10, minimum is 1, and higher scores are better. | Week 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-admission | Number of subjects readmitted. Lower is better. | 30 day re-admission | 
| Re-admission | Number of subjects readmitted. Lower is better. | 60 day re-admission | 
| Re-admission | Number of subjects readmitted. Lower is better. | 90 day re-admission | 
| Revised Caregiver Self-efficacy scale | Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy | Week 1 | 
| Revised Caregiver Self-efficacy scale | Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy | Week 12 | 
| Revised Caregiver Self-efficacy scale | Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy | Week 15 | 
| Zarit Burden Interview | Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88. | Week 1 | 
| Zarit Burden Interview | Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88. | Week 12 | 
| Zarit Burden Interview | Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88. | Week 15 | 
| WHO-BREF Quality of Life scale | World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each | Week 1 | 
| WHO-BREF Quality of Life scale | World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each | Week 12 | 
| WHO-BREF Quality of Life scale | World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each | Week 15 | 
| Single-item life satisfaction scale | Life Satisfaction Evaluation. Lower scores are better, range from 1 to 4 Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Satisfaction with life - one question | Week 1 | 
| Single-item life satisfaction scale | Life Satisfaction Evaluation. Lower scores are better, range from 1 to 4 Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Satisfaction with life - one question | Week 12 | 
| Single-item life satisfaction scale | Life Satisfaction Evaluation. Lower scores are better, range from 1 to 4 Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Satisfaction with life - one question | Week 15 | 
| Stroke Impact Scale | The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better. | Week 1 | 
| Stroke Impact Scale | The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better. | Week 12 | 
| Stroke Impact Scale | The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better. | Week 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver, Stroke, Coaching, Stress, Self-efficacy, Re-admission, Burden