Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07033897
Status
Recruiting
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Conditions

  • Adults
  • Disabilities Physical
  • Fall Prevention
  • Falls

Eligibility Criteria

Sex
ALL
Age
45 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Adapted HARP — BEHAVIORAL
    The adapted HARP intervention includes two to three in-home visits conducted by an OT practitioner over approximately 5 weeks in the homes of PwD. At the end of the first home visit, solutions to remove the identified fall hazards will be determined collaboratively with the participant, using motivational interviewing to establish hazards and shared-decision making and tailoring to help the participant brainstorm solutions to remove the hazards. Participants will then receive one to two additional visits from the OT, and a contractor if needed, to implement solutions using a self-management approach, identifying any additional hazards and subsequent modifications if necessary. All adaptive equipment and modifications will be provided at no cost to the participant. Booster visit(s) will be completed 3-6 months after the initial treatment sessions to ensure the home modifications are still appropriate, troubleshoot any equipment issues and review the self-management process.

Study Details

The Home Hazard Removal Program (HARP) is an effective fall prevention intervention program which targets home hazard identification/removal. In this study the investigators will examine the effectiveness and implementation potential of HARP, adapted for PwD. Investigators will conduct a pilot randomized control trial (RCT) to test the implementation, cost, and preliminary efficacy of an adapted version of HARP for community-dwelling PwD. The single-blinded feasibility RCT will randomize 40 participants to treatment (adapted HARP) and 40 to a waitlist control group. Data on specific types of fall hazards and resulting home modifications as well as falls and fall-related injuries (collected monthly over 12 months) and fear of falling (collected at baseline and 12 months) will inform the preliminary efficacy of adapted HARP among PwD. To ensure usefulness, relevance, and broad dissemination of findings, the investigators will adopt a "designing for implementation and dissemination" approach. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework will guide intervention adaptation, trial design, and future implementation. The Practical Robust Implementation and Sustainability Model (PRISM) guides study development by identifying multi-level contextual factors hypothesized to affect the RE-AIM outcomes.

Key Dates

Start date
Aug 20, 2025
Status verified
Nov 2025
Primary completion
Mar 14, 2028
Completion
Mar 14, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adapted HARP Intervention
    Participants in this group receive the adapted HARP intervention.
  • No Intervention: Waitlist Control
    Participants in this group receive virtual social visits. They will be offered the adapted HARP intervention after the 12-month follow-up visit is completed.

Primary Outcome Measure

Falls [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in St. LouisSt LouisMissouri63110
Susan Stark, PhD
[email protected]
314-935-2551

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By research site
Washington University in St. Louis· St Louis, MO

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