Coaching Intervention for Caregivers of Persons With Stroke

Stroke, Acute Clinical Trial

Official title:

Coaching Intervention for Caregivers of Persons With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04535284
• Other study ID #: 20D.718
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2021
• Source: Thomas Jefferson University
• Contact: Namrata Grampurohit, PhD
• Phone: 2063536054
• Email: namrata.grampurohit[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Caregiver Stress Syndrome
• Stroke
• Stroke, Acute

Intervention

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.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	American Occupational Therapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Re-admission	Number of subjects readmitted. Lower is better.	30 day re-admission
Secondary	Re-admission	Number of subjects readmitted. Lower is better.	60 day re-admission
Secondary	Re-admission	Number of subjects readmitted. Lower is better.	90 day re-admission
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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