Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities (HARP3)

The Washington University

Status: Begins enrollment this month

Conditions: Adults; Disabilities Physical; Falls; Fall Prevention

Treatments: Behavioral: Adapted HARP

Study type: Interventional

Funder types: Other

Identifiers

NCT07033897

MOHHU0088-24 (Other Grant/Funding Number)

202506116

Details and patient eligibility

About

The Home Hazard Removal Program (HARP) is an effective fall prevention intervention program which targets home hazard identification/removal. In this study we will examine the effectiveness and implementation potential of HARP, adapted for PwD. We 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, we 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.

Full description

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 we will examine the effectiveness and implementation potential of HARP, adapted for people with disabilities (PwD). We 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.

We 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, we 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 45 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 45-64 years; 2) self-report of difficulty with ≥2 daily activities; 3) have had a physical disability for ≥5 years (e.g., spinal cord injury, cerebral palsy, post-polio syndrome, stroke, amputation); 4) live in the City of St. Louis; 5) had a fall in the past year, or are worried about falling, or feel unsteady when standing or walking

Exclusion criteria

1. individuals who are institutionalized

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Adapted HARP Intervention

Experimental group

Description:

Participants in this group receive the adapted HARP intervention.

Treatment:

Behavioral: Adapted HARP

Waitlist Control

No Intervention group

Description:

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.