Clinical trial NCT04535284: Coaching Intervention for Caregivers of Persons With Stroke
Official title: Coaching Intervention for Caregivers of Persons With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caregiver Stress Syndrome
Caregiver Burnout
Stroke, Acute
Keywords: Caregiver
Stroke
Coaching
Stress
Self-efficacy
Re-admission
Burden
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
First posted: 2020-09-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized controlled trial design with two parallel groups
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: Week 1
measure: Canadian Occupational Performance Measure
timeFrame: Week 12
measure: Canadian Occupational Performance Measure
timeFrame: Week 15
Secondary outcomes:
measure: Re-admission
timeFrame: 30 day re-admission
measure: Re-admission
timeFrame: 60 day re-admission
measure: Re-admission
timeFrame: 90 day re-admission
measure: Revised Caregiver Self-efficacy scale
timeFrame: Week 1
measure: Revised Caregiver Self-efficacy scale
timeFrame: Week 12
measure: Revised Caregiver Self-efficacy scale
timeFrame: Week 15
measure: Zarit Burden Interview
timeFrame: Week 1
measure: Zarit Burden Interview
timeFrame: Week 12
measure: Zarit Burden Interview
timeFrame: Week 15
measure: WHO-BREF Quality of Life scale
timeFrame: Week 1
measure: WHO-BREF Quality of Life scale
timeFrame: Week 12
measure: WHO-BREF Quality of Life scale
timeFrame: Week 15
measure: Single-item life satisfaction scale
timeFrame: Week 1
measure: Single-item life satisfaction scale
timeFrame: Week 12
measure: Single-item life satisfaction scale
timeFrame: Week 15
measure: Stroke Impact Scale
timeFrame: Week 1
measure: Stroke Impact Scale
timeFrame: Week 12
measure: Stroke Impact Scale
timeFrame: Week 15
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References: