Home Hazard Removal Program to Reduce Falls

NCT ID: NCT02392013

Last Updated: 2025-08-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-24

Study Completion Date

2017-12-31

Brief Summary

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This study evaluates the effectiveness and implementation of a home-hazard removal program to reduce falls in older adults through a community program delivered through the aging services network. The investigators will conduct a hybrid effectiveness/implementation trial of 300 older adults at risk for a fall who will be randomized to a home-hazard removal program or usual care and then followed for 12 months. Investigators will look at the number of falls at 6 months and 12 months.

Detailed Description

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The investigators will randomly select a sample of older adults from the large observational cohort of older adults assessed annually by an Area Agendy on Aging via the National Aging Program Information System (NAPIS). The eligibility criteria include age 65 years or older and self-report of one previous fall or more in the preceding 12 months or self-report as "worried about falling." We will conduct baseline assessments and randomize participants to receive an home hazard removal program or usual care. Outcomes (falls, fall self-efficacy) will be assessed by a blinded rater at baseline and 12 months after intervention. All assessments and study visits will occur in participants' homes.

Conditions

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Accidental Falls

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Home Modification Group

A tailored home-modification (home-hazard removal) intervention delivered in the home by occupational therapists over three visits and with a booster session at six months.

Group Type EXPERIMENTAL

Home Modification

Intervention Type OTHER

Removal of home barriers or hazards.

Usual Care Group

Usual care by an Area Agency on Aging

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home Modification

Removal of home barriers or hazards.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals aged 65 years or older and self-report of one previous fall or more in the preceding 12 months or self-report as "worried about falling."

Exclusion Criteria

* Individuals residing in nursing homes or individuals with severe cognitive impairment who are unable to give consent to participate (as determined by a score of greater than 10 on the SBT for memory10).
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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US Department of Housing and Urban Development

FED

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Susan Stark

Assisstant Professor of Neurology and Occupational Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan L Stark, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Occupational Therapy Program at Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Stark S, Keglovits M, Somerville E, Hu YL, Barker A, Sykora D, Yan Y. Home Hazard Removal to Reduce Falls Among Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2122044. doi: 10.1001/jamanetworkopen.2021.22044.

Reference Type DERIVED
PMID: 34463746 (View on PubMed)

Stark S, Somerville E, Keglovits M, Conte J, Li M, Hu YL, Yan Y. Protocol for the home hazards removal program (HARP) study: a pragmatic, randomized clinical trial and implementation study. BMC Geriatr. 2017 Apr 20;17(1):90. doi: 10.1186/s12877-017-0478-4.

Reference Type DERIVED
PMID: 28427336 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MOHHU0024-14

Identifier Type: -

Identifier Source: org_study_id

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