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Stroke Caregiver Empowerment (STROKE-CARE)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STROKE-CARE
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Empowerment, Caregiver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years or older
  • Primary caregiver for an individual post-stroke
  • Live with the care-recipient
  • Provide 1 hour of caregiving per day
  • Subjective caregiver burden

Exclusion Criteria:

  • non-English speaking
  • Active treatment (chemotherapy, radiation therapy) for cancer
  • Imminent placement of care-recipient into a nursing home or with another caregiver (within 6 months)
  • Involvement in another clinical trial for caregivers

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STROKE-CARE Intervention

Arm Description

In STROKE-CARE, caregivers will learn a problem-solving strategy. Participants will receive approximately 10 sessions by an occupational therapist in the home over a 5 week process.

Outcomes

Primary Outcome Measures

The proportion of caregivers that use the universal strategy in daily activities

Secondary Outcome Measures

Full Information

First Posted
March 31, 2016
Last Updated
July 1, 2021
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02772445
Brief Title
Stroke Caregiver Empowerment
Acronym
STROKE-CARE
Official Title
Stroke Caregiver Empowerment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to refine STROKE-CARE for caregivers and explore changes in caregiver and care-recipient outcomes
Detailed Description
Individuals with disabilities rely heavily on unpaid family caregivers to help perform necessary occupations. The emotional and physical demands of caregiving often contribute to caregivers experiencing burden. Caregivers with burden are at-risk for poor health and a heightened risk of mortality. This is likely, in turn, to negatively impact care-recipient quality of life. The proposed study refines a behavioral intervention that teaches caregivers to facilitate problem solving over the course of daily activities. The long-term goal for this project is to establish an effective rehabilitation intervention that promotes caregiver health and well-being, which ultimately influences care-recipient health. This study will use an open-case series and a single-arm clinical trial to refine the intervention and examine caregiver and care-recipient response to the intervention. This research applies to the priorities and objectives of this research initiative through examination of a caregiver-centered, standardized intervention that is based on occupational theories and principles, investigating outcomes experienced by caregivers of individuals with cognitive deficits after stroke. Data from this pilot project will be used to design and obtain federal funding for a randomized controlled trial to examine the efficacy of the refined intervention on caregiver and care-recipient health outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Empowerment, Caregiver

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STROKE-CARE Intervention
Arm Type
Experimental
Arm Description
In STROKE-CARE, caregivers will learn a problem-solving strategy. Participants will receive approximately 10 sessions by an occupational therapist in the home over a 5 week process.
Intervention Type
Behavioral
Intervention Name(s)
STROKE-CARE
Intervention Description
In STROKE-CARE, caregivers will learn a problem-solving strategy. They will (1) identify barriers to performance, (2) generate strategies to address barriers, and (3) apply these strategies to support care-recipients in occupations.
Primary Outcome Measure Information:
Title
The proportion of caregivers that use the universal strategy in daily activities
Time Frame
after study completion, an average of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older Primary caregiver for an individual post-stroke Live with the care-recipient Provide 1 hour of caregiving per day Subjective caregiver burden Exclusion Criteria: non-English speaking Active treatment (chemotherapy, radiation therapy) for cancer Imminent placement of care-recipient into a nursing home or with another caregiver (within 6 months) Involvement in another clinical trial for caregivers
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Stroke Caregiver Empowerment

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