Recruiting

HARP

Sponsor:

Washington University School of Medicine

Code:

NCT07033897

Conditions

Disabilities Physical

Falls

Fall Prevention

Adults

Eligibility Criteria

Sex: All

Age: 45 - 64

Healthy Volunteers: Not accepted

Interventions

Adapted HARP

Study Details

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.

Conditions

Disabilities Physical

Falls

Fall Prevention

Adults

Study ID

NCT07033897

Start date

Aug 20, 2025

Status verified date

Nov, 2025

Completion date

Mar 14, 2028

Anticipated

Primary completion date

Mar 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Adapted HARP

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.

Primary outcome measure

  • Falls [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Susan L Stark, PhD

(314)935-2551sstark@wustl.edu

Rebecca M Bollinger, OTD

(314)935-2503rebecca.m.bollinger@wustl.edu

Locations

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Susan Stark, PhD

314-935-2551sstark@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

  • Fall prevention
  • Falls
  • People with disabilities
  • Adults
  • Home Hazard Removal Program
  • Occupational Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-11-14.