Stroke Caregiver Empowerment

Stroke Clinical Trial

— STROKE-CARE  

Official title:

Stroke Caregiver Empowerment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772445
• Other study ID #: PRO16020650
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of caregivers that use the universal strategy in daily activities		after study completion, an average of 6 weeks