Coaching Intervention for Caregivers of Persons With Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute; Caregiver Stress Syndrome; Caregiver Burnout
• Intervention / Treatment: Behavioral: Coaching

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Namrata Grampurohit, PhD; Phone Number: 2063536054; Email: namrata.grampurohit@jefferson.edu
• Study Contact Backup: Name: Erica Witoslawski, BS; Phone Number: 2155030527; Email: exw086@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
      • Contact: Namrata Grampurohit, PhD; Phone Number: 206-353-6054; Email: namrata.grampurohit@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: American Occupational Therapy Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2020
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; Stress; Caregiver; Burden; Self-efficacy; Coaching; Re-admission
• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stress, Psychological; Stroke; Caregiver Burden
• Other Study ID Numbers: 20D.718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared within the research team. De-identified data will be made publicly available on a repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No