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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02392013
Other study ID # MOHHU0024-14
Secondary ID
Status Completed
Phase N/A
First received March 5, 2015
Last updated January 30, 2018
Start date December 2014
Est. completion date December 2017

Study information

Verified date January 2018
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 313
Est. completion date December 2017
Est. primary completion date November 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Home Modification
Removal of home barriers or hazards.

Locations

Country Name City State
United States Occupational Therapy Program at Washington University School of Medicine Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine US Department of Housing and Urban Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of falls Prospective daily reporting of falls using a calendar 12 months
Secondary Daily activity performance. Participant daily activity performance will be measured by the Older Americans Resources and Services (OARS) ADL Scale 12 months
Secondary Fall self-efficacy. Participant self-efficacy in performing daily activities without falling will be measured by the Falls Efficacy Scale-International (FES-I). 12 months
Secondary Health-related quality of life. Participant self-reported health will be measured using the SF-36. 12 months
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