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

NCT07033897 | Recruiting

• 2 other identifiers: 202506116MOHHU0088-24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Falls

  Reduction in fall rates

  12 months

Study Arms (2)

Adapted HARP Intervention

EXPERIMENTAL

Participants in this group receive the adapted HARP intervention.

Behavioral: Adapted HARP

Waitlist Control

NO INTERVENTION

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 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.

Adapted HARP Intervention

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• individuals who are institutionalized

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Study Officials

• Susan L Stark, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan L Stark, PhD

CONTACT

(314)935-2551; sstark@wustl.edu

Rebecca M Bollinger, OTD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): March 14, 2028
• Study Completion (Estimated): March 14, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after the curation period for a minimum of 10 years
• Access Criteria: De-identified data will be made available to the public

Locations

US (1)