Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MOHHU0088-24 | Other Grant/Funding Number | Department of Housing and Urban Development |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.](streamdown:incomplete-link)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted HARP Intervention | Experimental | Participants in this group receive the adapted HARP intervention. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Falls | Reduction in fall rates | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
• individuals who are institutionalized
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan L Stark, PhD | Contact | (314)935-2551 | sstark@wustl.edu | |
| Rebecca M Bollinger, OTD | Contact | (314)935-2503 | rebecca.m.bollinger@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Susan L Stark, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | Recruiting | St Louis | Missouri | 63110 | United States |
Final de-identified data will be preserved and shared with the public via WashU Research Data, an institutional repository managed by the Washington University in St. Louis Libraries. Datasets submitted to the data repository undergo curation prior to publication to ensure that the data are functioning, in the appropriate format, and well documented to facilitate long-term FAIRness (findable, accessible, interoperable and reusable). Submissions receive digital object identifiers minted with DataCite, and the library will retain the deposits for a minimum of 10 years.
Not provided
Data will be available after the curation period for a minimum of 10 years
De-identified data will be made available to the public
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|