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Adapting, Implementing and Evaluating the Effectiveness of the Home Hazard Removal Program for People With Disabilities
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.
The Home Hazard Removal Program (HARP) is an effective fall prevention intervention program which targets home hazard identification/removal, previously demonstrating a 38% reduction in falls among older adults with high fall risk. In this study investigators will examine the effectiveness and implementation potential of HARP, adapted for people with disabilities (PwD). The investigators will use a hybrid approach including a pilot RCT and a mixed methods study (semi-structured interviews and focus group) to adapt and examine the implementation and preliminary efficacy of HARP. The investigators will conduct a Phase IIb pilot RCT study to test the feasibility and preliminary efficacy of an adapted version of HARP in community-dwelling PwD. The single-blinded RCT will randomize 40 participants to adapted HARP and 40 to waitlist control. 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, which guides planning and outcome evaluation of programming, will guide intervention adaptation, trial design, and future implementation. The Practical Robust Implementation and Sustainability Model (PRISM) has guided study development by identifying multi-level contextual factors hypothesized to affect the RE-AIM outcomes. Mixed methods using both quantitative and qualitive data (i.e., semi-structured interviews with 10 participants and a focus group with stakeholders \[e.g., St. Louis Area Agency on Aging case managers, referral and evaluation specialists) will incorporate metrics from PRISM and RE-AIM, such as enrollment metrics, fidelity of implementation, number and specific location of fall hazards in the home, number, type and cost of home modifications, long-term adherence to home modifications and reduction in home hazards, qualitative perspectives on strengths and barriers, and willingness to adopt similar programming. Data will be used to identify the specific location of fall hazards, places where falls tend to occur in the home, and strategies to remediate these hazards.
Age
45 - 64 years
Sex
ALL
Healthy Volunteers
No
Washington University in St. Louis
St Louis, Missouri, United States
Start Date
August 20, 2025
Primary Completion Date
March 14, 2028
Completion Date
March 14, 2028
Last Updated
November 14, 2025
80
ESTIMATED participants
Adapted HARP
BEHAVIORAL
Lead Sponsor
Washington University School of Medicine
NCT07112573
NCT05846685
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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