Stroke Caregiver Empowerment

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: STROKE-CARE

• Registration Number: NCT02772445
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2016-03-31
• Study Start: 2016-04
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-13
• Primary Completion: 2018-03
• Study Completion: 2018-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-01
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STROKE-CARE Intervention	STROKE-CARE	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States