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Coaching Intervention for Caregivers of Persons With Stroke

Coaching Intervention for Caregivers of Persons With Stroke

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04535284
Enrollment
80
Registered
2020-09-01
Start date
2020-08-24
Completion date
2022-07-31
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Burnout, Caregiver Stress Syndrome, Stroke, Acute

Keywords

Caregiver, Stroke, Coaching, Stress, Self-efficacy, Re-admission, Burden

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.

Interventions

BEHAVIORALCoaching

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.

Sponsors

American Occupational Therapy Foundation
CollaboratorOTHER
Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessor will be blinded to treatment group allocation

Intervention model description

Single-blind randomized controlled trial design with two parallel groups

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Canadian Occupational Performance MeasureWeek 1Measure 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

MeasureTime frameDescription
Revised Caregiver Self-efficacy scaleWeek 1Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy
Zarit Burden InterviewWeek 1Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.
Re-admission30 day re-admissionNumber of subjects readmitted. Lower is better.
Single-item life satisfaction scaleWeek 1Life 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 ScaleWeek 1The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better.
WHO-BREF Quality of Life scaleWeek 1World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each

Countries

United States

Contacts

Primary ContactNamrata Grampurohit, PhD
namrata.grampurohit@jefferson.edu2063536054
Backup ContactErica Witoslawski, BS
exw086@jefferson.edu2155030527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026