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Stroke Caregiver Empowerment (STROKE-CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02772445
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : July 6, 2021
Information provided by (Responsible Party):
Juleen Rodakowski, 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

Condition or disease Intervention/treatment Phase
Stroke Behavioral: STROKE-CARE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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.

Primary Outcome Measures :
  1. The proportion of caregivers that use the universal strategy in daily activities [ Time Frame: after study completion, an average of 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02772445

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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15221
Sponsors and Collaborators
University of Pittsburgh
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Responsible Party: Juleen Rodakowski, Assistant Professor, University of Pittsburgh Identifier: NCT02772445    
Other Study ID Numbers: PRO16020650
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Juleen Rodakowski, University of Pittsburgh:
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases