A randomized controlled trial of an innovative in-home rehabilitation program for persons with TBI and their families: Home-based Occupational-therapy and Management of the Environment (HOME for Us)

Information

  • Research Project
  • 10052524
  • ApplicationId
    10052524
  • Core Project Number
    R01NR018655
  • Full Project Number
    1R01NR018655-01A1
  • Serial Number
    018655
  • FOA Number
    PA-18-383
  • Sub Project Id
  • Project Start Date
    9/15/2020 - 4 years ago
  • Project End Date
    6/30/2025 - 4 months from now
  • Program Officer Name
    HUSS, KAREN
  • Budget Start Date
    9/15/2020 - 4 years ago
  • Budget End Date
    6/30/2021 - 3 years ago
  • Fiscal Year
    2020
  • Support Year
    01
  • Suffix
    A1
  • Award Notice Date
    9/15/2020 - 4 years ago
Organizations

A randomized controlled trial of an innovative in-home rehabilitation program for persons with TBI and their families: Home-based Occupational-therapy and Management of the Environment (HOME for Us)

Recognized as a major public health problem for civilian and military populations, traumatic brain injury (TBI) produces a broad range of cognitive, emotional, behavioral, and physical symptoms. These symptoms impede community reintegration (participation in family, work, school, meaningful activities) and decrease quality of life (QoL). TBI also has a profound impact on family caregivers, who often struggle with depression, high levels of burden from caregiving demands, and many unmet needs. Standard approaches to TBI care typically provide post-acute rehabilitation for recent injuries (within 1 year post injury). Yet, years after injury, many persons still experience chronic TBI symptoms and are often left to manage these on their own. Furthermore, standard rehabilitation focuses primarily on medical restoration to reduce deficits rather than on symptom management, is clinic based, and rarely engages families, despite their critical role in rehabilitation. The proposed randomized controlled trial (RCT) will evaluate an innovative rehabilitation approach for persons with chronic TBI-related symptoms (> 1 year post injury) and their families. Based on the person- environment fit framework, HOME (Home-based Occupational-therapy and Management of the Environment) for Us is a 4-month, 8-session intervention delivered by occupational therapists in the home, designed to improve community reintegration, ability to manage self-identified TBI-related problems, and quality of life in persons with TBI. HOME targets the home environment (physical and social) to realign environmental demands to individual strengths and deficits. HOME engages persons with TBI and family caregivers in strategies to manage chronic TBI symptoms. It educates family members to reinforce and maintain intervention strategies, and also addresses family needs. Our earlier research with veterans with TBI demonstrated the efficacy of this approach in improving community reintegration and ability to manage self-identified TBI-related problems. Family members experienced lower depressive symptoms and caregiver burden, compared to controls, and the program was highly acceptable to both. These findings warrant moving forward to extend the project by: including civilians with TBI as well as veterans; using an attention-control condition; testing maintenance effects at 6 months after treatment completion and exploring generalization to new problems or situations. A 2-group randomized controlled trial will be conducted with 220 community-dwelling civilians and veterans with chronic TBI-related symptoms (> 1 year post injury) and their family caregivers. Outcomes for persons with TBI will be community reintegration, quality of life, and ability to manage patient-identified TBI-related problems. Family caregiver outcomes will be burden, depressive symptoms, and met family needs. Treatment effects will be compared to controls at 4 months, and maintenance and generalization effects will be evaluated at 10 months. The study addresses a critical gap in services and research for persons with chronic TBI symptoms and their families.

IC Name
NATIONAL INSTITUTE OF NURSING RESEARCH
  • Activity
    R01
  • Administering IC
    NR
  • Application Type
    1
  • Direct Cost Amount
    491593
  • Indirect Cost Amount
    217743
  • Total Cost
    709336
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    361
  • Ed Inst. Type
    SCHOOLS OF NURSING
  • Funding ICs
    NINR:709336\
  • Funding Mechanism
    Non-SBIR/STTR RPGs
  • Study Section
    CMPC
  • Study Section Name
    Clinical Management of Patients in Community-based Settings Study Section
  • Organization Name
    VILLANOVA UNIVERSITY
  • Organization Department
    NONE
  • Organization DUNS
    071618789
  • Organization City
    VILLANOVA
  • Organization State
    PA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    190851603
  • Organization District
    UNITED STATES