Stroke Caregiver Empowerment (STROKE-CARE)

University of Pittsburgh

Status: Completed

Conditions: Stroke

Treatments: Behavioral: STROKE-CARE

Study type: Interventional

Funder types: Other

Identifiers

NCT02772445

PRO16020650

Details and patient eligibility

About

The purpose of this study is to refine STROKE-CARE for caregivers and explore changes in caregiver and care-recipient outcomes

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

STROKE-CARE Intervention

Experimental group

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.

Treatment:

Behavioral: STROKE-CARE