NCT07033897 Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities
| NCT ID | NCT07033897 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Disabilities Physical |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-08-20 |
| Primary Completion | 2028-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-08-20 with a primary completion date of 2028-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * age 45-64 years * self-report of difficulty with ≥2 daily activities * have had a physical disability for ≥5 years (e.g., spinal cord injury, cerebral palsy, post-polio syndrome, stroke, amputation) * live in the City of St. Louis * had a fall in the past year, or are worried about falling, or feel unsteady when standing or walking Exclusion Criteria: • individuals who are institutionalized
Contact & Investigator
Susan L Stark, PhD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT07033897 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 64 Years, studying Disabilities Physical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07033897 currently recruiting?
Yes, NCT07033897 is actively recruiting participants. Contact the research team at sstark@wustl.edu for enrollment information.
Where is the NCT07033897 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT07033897 clinical trial?
NCT07033897 is sponsored by Washington University School of Medicine. The principal investigator is Susan L Stark, PhD at Washington University School of Medicine. The trial plans to enroll 80 participants.