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NCT Number: NCT07033897

Adapting, Implementing and Evaluating the Effectiveness of HARP 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.

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Key information

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Susan Stark, PhD

CONTACT

[email protected]

314-935-2551

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Falls

    Time frame: 12 months

    Reduction in fall rates

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca M Bollinger, OTD

CONTACT

[email protected]

(314)935-2503

Susan L Stark, PhD

CONTACT

[email protected]

(314)935-2551

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Adapting, Implementing and Evaluating the Effectiveness of the Home Hazard Removal Program for People With Disabilities

Acronym: HARP3

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2025
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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