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OpenTrials
Completed

NCT Number: NCT02772445

Stroke Caregiver Empowerment

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15221, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STROKE-CARE

Behavioral

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 outcomes

  1. The proportion of caregivers that use the universal strategy in daily activities

    Time frame: after study completion, an average of 6 weeks

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Acronym: STROKE-CARE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 13, 2016
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.