NCT02392013

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

August 30, 2024

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

March 5, 2015

Results QC Date

August 10, 2023

Last Update Submit

August 25, 2025

Conditions

Accidental Falls

Keywords

older adult fallshome hazardshome barriers

Outcome Measures

Primary Outcomes (1)

  • Number of Falls

    Prospective daily reporting of falls using a calendar

    12 months

Secondary Outcomes (3)

  • Daily Activity Performance.

    12 months

  • Fear of Falling

    12 months

  • Health-related Quality of Life.

    12 months

Study Arms (2)

Home Modification Group

EXPERIMENTAL

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.

Other: Home Modification

Usual Care Group

NO INTERVENTION

Usual care by an Area Agency on Aging

Interventions

Home ModificationOTHER

Removal of home barriers or hazards.

Home Modification Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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."

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Occupational Therapy Program at Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • 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.

    PMID: 34463746DERIVED

  • 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.

    PMID: 28427336DERIVED

Results Point of Contact

Title
Dr. Susy Stark
Organization
Washington University in St. Louis
sstark@wustl.edu
3142734114

Study Officials

  • Susan L Stark, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor of Neurology and Occupational Therapy

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 18, 2015

Study Start

February 24, 2015

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

August 27, 2025

Results First Posted

August 30, 2024

Record last verified: 2025-08

Locations

US(1)