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Coaching Intervention for Caregivers of Persons With Stroke

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ClinicalTrials.gov Identifier: NCT04535284
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Collaborator:
American Occupational Therapy Foundation
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Caregiver Stress Syndrome Caregiver Burnout Stroke, Acute Behavioral: Coaching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-blind randomized controlled trial design with two parallel groups
Masking: Single (Outcomes Assessor)
Masking Description: Assessor will be blinded to treatment group allocation
Primary Purpose: Treatment
Official Title: Coaching Intervention for Caregivers of Persons With Stroke
Estimated Study Start Date : August 24, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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 Name: 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.



Primary Outcome Measures :
  1. Canadian Occupational Performance Measure [ Time Frame: Week 1 ]
    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.

  2. Canadian Occupational Performance Measure [ Time Frame: Week 12 ]
    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.

  3. Canadian Occupational Performance Measure [ Time Frame: Week 15 ]
    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 :
  1. Re-admission [ Time Frame: 30 day re-admission ]
    Number of subjects readmitted. Lower is better.

  2. Re-admission [ Time Frame: 60 day re-admission ]
    Number of subjects readmitted. Lower is better.

  3. Re-admission [ Time Frame: 90 day re-admission ]
    Number of subjects readmitted. Lower is better.

  4. Revised Caregiver Self-efficacy scale [ Time Frame: Week 1 ]
    Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy

  5. Revised Caregiver Self-efficacy scale [ Time Frame: Week 12 ]
    Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy

  6. Revised Caregiver Self-efficacy scale [ Time Frame: Week 15 ]
    Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy

  7. Zarit Burden Interview [ Time Frame: Week 1 ]
    Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.

  8. Zarit Burden Interview [ Time Frame: Week 12 ]
    Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.

  9. Zarit Burden Interview [ Time Frame: Week 15 ]
    Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.

  10. WHO-BREF Quality of Life scale [ Time Frame: Week 1 ]
    World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each

  11. WHO-BREF Quality of Life scale [ Time Frame: Week 12 ]
    World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each

  12. WHO-BREF Quality of Life scale [ Time Frame: Week 15 ]
    World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each

  13. Single-item life satisfaction scale [ Time Frame: Week 1 ]
    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

  14. Single-item life satisfaction scale [ Time Frame: Week 12 ]
    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

  15. Single-item life satisfaction scale [ Time Frame: Week 15 ]
    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

  16. Stroke Impact Scale [ Time Frame: Week 1 ]
    The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better.

  17. Stroke Impact Scale [ Time Frame: Week 12 ]
    The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better.

  18. Stroke Impact Scale [ Time Frame: Week 15 ]
    The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535284


Contacts
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Contact: Namrata Grampurohit, PhD 2063536054 namrata.grampurohit@jefferson.edu
Contact: Erica Witoslawski, BS 2155030527 exw086@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Namrata Grampurohit, PhD    206-353-6054    namrata.grampurohit@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
American Occupational Therapy Foundation
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04535284    
Other Study ID Numbers: 20D.718
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared within the research team. De-identified data will be made publicly available on a repository.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Jefferson University:
Caregiver
Stroke
Coaching
Stress
Self-efficacy
Re-admission
Burden
Additional relevant MeSH terms:
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Stroke
Burnout, Psychological
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Stress, Psychological
Behavioral Symptoms