Home Hazard Removal Program to Reduce Falls

Not Applicable

Completed

• Conditions: Accidental Falls
• Interventions: Other: Home Modification

• Registration Number: NCT02392013
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-02-24
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-18
• Primary Completion: 2017-11
• Study Completion: 2017-12
• Results First Submitted: 2023-08-10
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Results First Posted: 2024-08-30
• Last Update Posted: 2024-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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."

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Modification Group	Home Modification	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.

Primary Outcome Measures

Name	Time	Method
Number of Falls	12 months	Prospective daily reporting of falls using a calendar

Secondary Outcome Measures

Name	Time	Method
Daily Activity Performance.	12 months	Participant daily activity performance will be measured by the Older Americans Resources and Services (OARS) ADL Scale. OARS = Older Americans Resources and Services scores range from 0-28 with higher scores indicating more independence in daily activities
Fear of Falling	12 months	Concern about falling was measured using the Short Falls Efficacy Scale-International (FES-I). Respondents rate their level of concern about falling when they perform 7 different activities. Response options range from 1 (not at all concerned) to 4 (very concerned) . Scores are summed across items, and total scores range from 7 (no concern) to 28 (severe concern).
Health-related Quality of Life.	12 months	Participant self-reported health will be measured using the SF-36. Patients rate responses that are then scored and transformed to a 0-100 scale where higher scores indicate greater quality of life.

Trial Locations

Locations (1)

Occupational Therapy Program at Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States