search
Back to results

Coaching Intervention for Caregivers of Persons With Stroke

Primary Purpose

Caregiver Stress Syndrome, Caregiver Burnout, Stroke, Acute

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coaching
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caregiver Stress Syndrome focused on measuring Caregiver, Stroke, Coaching, Stress, Self-efficacy, Re-admission, Burden

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Coaching

Usual Care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Re-admission
Number of subjects readmitted. Lower is better.
Re-admission
Number of subjects readmitted. Lower is better.
Re-admission
Number of subjects readmitted. Lower is better.
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
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
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
Zarit Burden Interview
Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.
Zarit Burden Interview
Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.
Zarit Burden Interview
Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.
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
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
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
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
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
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
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.
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.
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.

Full Information

First Posted
August 6, 2020
Last Updated
October 4, 2021
Sponsor
Thomas Jefferson University
Collaborators
American Occupational Therapy Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT04535284
Brief Title
Coaching Intervention for Caregivers of Persons With Stroke
Official Title
Coaching Intervention for Caregivers of Persons With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
American Occupational Therapy Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Stress Syndrome, Caregiver Burnout, Stroke, Acute
Keywords
Caregiver, Stroke, Coaching, Stress, Self-efficacy, Re-admission, Burden

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind randomized controlled trial design with two parallel groups
Masking
Outcomes Assessor
Masking Description
Assessor will be blinded to treatment group allocation
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coaching
Arm Type
Experimental
Arm Description
Health Coaching-in-Context" includes coaching by trained coaches up to 10 sessions over teleconference.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coaching
Other Intervention Name(s)
Health Coaching in Context
Intervention Description
"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.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Description
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.
Time Frame
Week 1
Title
Canadian Occupational Performance Measure
Description
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.
Time Frame
Week 12
Title
Canadian Occupational Performance Measure
Description
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.
Time Frame
Week 15
Secondary Outcome Measure Information:
Title
Re-admission
Description
Number of subjects readmitted. Lower is better.
Time Frame
30 day re-admission
Title
Re-admission
Description
Number of subjects readmitted. Lower is better.
Time Frame
60 day re-admission
Title
Re-admission
Description
Number of subjects readmitted. Lower is better.
Time Frame
90 day re-admission
Title
Revised Caregiver Self-efficacy scale
Description
Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy
Time Frame
Week 1
Title
Revised Caregiver Self-efficacy scale
Description
Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy
Time Frame
Week 12
Title
Revised Caregiver Self-efficacy scale
Description
Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy
Time Frame
Week 15
Title
Zarit Burden Interview
Description
Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.
Time Frame
Week 1
Title
Zarit Burden Interview
Description
Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.
Time Frame
Week 12
Title
Zarit Burden Interview
Description
Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.
Time Frame
Week 15
Title
WHO-BREF Quality of Life scale
Description
World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each
Time Frame
Week 1
Title
WHO-BREF Quality of Life scale
Description
World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each
Time Frame
Week 12
Title
WHO-BREF Quality of Life scale
Description
World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each
Time Frame
Week 15
Title
Single-item life satisfaction scale
Description
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
Time Frame
Week 1
Title
Single-item life satisfaction scale
Description
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
Time Frame
Week 12
Title
Single-item life satisfaction scale
Description
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
Time Frame
Week 15
Title
Stroke Impact Scale
Description
The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better.
Time Frame
Week 1
Title
Stroke Impact Scale
Description
The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better.
Time Frame
Week 12
Title
Stroke Impact Scale
Description
The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better.
Time Frame
Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Namrata Grampurohit, PhD
Phone
2063536054
Email
namrata.grampurohit@jefferson.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Witoslawski, BS
Phone
2155030527
Email
exw086@jefferson.edu
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Namrata Grampurohit, PhD
Phone
206-353-6054
Email
namrata.grampurohit@jefferson.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared within the research team. De-identified data will be made publicly available on a repository.

Learn more about this trial

Coaching Intervention for Caregivers of Persons With Stroke

We'll reach out to this number within 24 hrs