Coaching Intervention for Caregivers of Persons With Stroke

NCT ID: NCT04535284

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-24
• Study Completion Date: 2022-07-31

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.

Conditions

Caregiver Stress Syndrome; Caregiver Burnout; Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Coaching

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

Group Type: EXPERIMENTAL

Coaching

Intervention Type: BEHAVIORAL

"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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Health Coaching in Context

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Occupational Therapy Foundation

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Namrata Grampurohit, PhD

Role: CONTACT

namrata.grampurohit@jefferson.edu

2063536054

Erica Witoslawski, BS

Role: CONTACT

exw086@jefferson.edu

2155030527

Facility Contacts

Namrata Grampurohit, PhD

Role: primary

namrata.grampurohit@jefferson.edu

206-353-6054

Other Identifiers

20D.718

Identifier Type: -

Identifier Source: org_study_id