Coaching Intervention for Caregivers of Persons With Stroke

Sponsor

Thomas Jefferson University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04535284

Collaborator

American Occupational Therapy Foundation (Other)

Enrollment

Location

Arms

23.2

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Caregiver Stress Syndrome Caregiver Burnout Stroke, Acute	Behavioral: Coaching	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single-blind randomized controlled trial design with two parallel groupsSingle-blind randomized controlled trial design with two parallel groups

Masking:

Single (Outcomes Assessor)

Masking Description:

Assessor will be blinded to treatment group allocation

Primary Purpose:

Treatment

Official Title:

Coaching Intervention for Caregivers of Persons With Stroke

Actual Study Start Date :

Aug 24, 2020

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coaching Health Coaching-in-Context" includes coaching by trained coaches up to 10 sessions over teleconference.	Behavioral: Coaching "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. Other Names: Health Coaching in Context
No Intervention: Usual Care 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.

Arm

Intervention/Treatment

Experimental: Coaching

Health Coaching-in-Context" includes coaching by trained coaches up to 10 sessions over teleconference.

Behavioral: Coaching

"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.

Other Names:

Health Coaching in Context

No Intervention: Usual Care

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.

Outcome Measures

Primary Outcome Measures

Canadian Occupational Performance Measure [Week 1]
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.
Canadian Occupational Performance Measure [Week 12]
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.
Canadian Occupational Performance Measure [Week 15]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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