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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.
 
ClinicalTrials.gov Identifier: NCT02772445
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Juleen Rodakowski, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date January 22, 2019
Study Start Date  ICMJE April 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
The proportion of caregivers that use the universal strategy in daily activities [ Time Frame: after study completion, an average of 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stroke Caregiver Empowerment
Official Title  ICMJE Stroke Caregiver Empowerment
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Stroke
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: STROKE-CARE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2019)
23
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2016)
25
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772445
Other Study ID Numbers  ICMJE PRO16020650
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Juleen Rodakowski, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pittsburgh
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP