STROKE-CARE: Stroke Caregiver Empowerment

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT02772445

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: STROKE-CARE	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Stroke Caregiver Empowerment

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STROKE-CARE Intervention 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.	Behavioral: STROKE-CARE 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.

Arm

Intervention/Treatment

Experimental: STROKE-CARE Intervention

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.

Behavioral: STROKE-CARE

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.

Outcome Measures

Primary Outcome Measures

The proportion of caregivers that use the universal strategy in daily activities [after study completion, an average of 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15221

Sponsors and Collaborators

University of Pittsburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Juleen Rodakowski, Assistant Professor, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT02772445

Other Study ID Numbers:

PRO16020650

First Posted:

May 13, 2016

Last Update Posted:

Jul 6, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Juleen Rodakowski, Assistant Professor, University of Pittsburgh

Empowerment

Caregiver

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jul 6, 2021