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

ConditionsDisabilities Physical Falls Fall Prevention Adults

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45-64

SponsorWashington University School of Medicine

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Adapted HARP InterventionExperimental treatment 1 intervention

Group B: Waitlist ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Falls

Reduction in fall rates

Time frame

12 months

Sponsors and contacts

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Washington University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

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