The Effectiveness of a Fall Prevention Program

NCT01833182 | Completed DMC

• 1 other identifier: MOLHH0196-09
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 of the study: Falls are the leading cause of preventable injury, long term disability, premature institutionalization and mortality in the older adult population. Promising preliminary research suggests that modifications to the home can potentially reduce the incidence of falls in the elderly. The purpose of this study is to gather data necessary to design a definitive trial of a home modification intervention for older adults at risk for fall. The specific aims are to 1) estimate the efficacy of an intensive tailored environmental intervention to reduce functional decline among community-dwelling older adults; 2) gather the data necessary to design a definitive clinical trial of an intensive tailored environmental intervention to reduce the cumulative incidence of falls among community-dwelling older adults; 3) examine the direct cost of intensive tailored home modification. A pilot randomized controlled trial will be conducted with 40 older adults who have experienced a fall resulting in an emergency room visit. Phase 2 of the study: Our long-term objective is to prevent falls for these older adults at high risk by removing hazards in their homes. Development of an effective intervention for fall reduction could have an immediate impact for this population and high public health significance. Intensive home hazard removal has been established as an effective environmental intervention for the prevention of falls; however, none of the published studies have been conducted in the US, and no study has adequately controlled for biases. The investigators propose a double-blinded, randomized sham-controlled clinical trial to determine the efficacy of an intensive tailored home hazard removal intervention to reduce the cumulative incidence of falls among 110 community-dwelling older adults who visit the emergency department (ED) because of a fall. This three year study will be the first to utilize a sham control group and a double-blind, randomized study design. The investigators will intervene with a high-risk group of community-dwelling older adults who visit an ED after a fall. The primary hypothesis will be tested by comparing the 12-month cumulative incidence of falls in an intensive tailored home intervention group with falls in a sham control group. Falls will be operationalized as unintentional movements to the floor, ground or object below knee level. The secondary hypothesis will be tested by comparing total number of falls, number of injurious falls, fear of falling and performance in daily activities between the intervention and sham control group. The primary aim of the proposed study is to:

1. 1.Compare the efficacy of an intensive tailored home hazard reduction intervention to sham treatment on the cumulative incidence of falls over 12 months for older adults who visit the ED after a fall.
2. 2.Determine if intensive tailored home hazard reduction intervention is superior to sham treatment on secondary outcomes including: total number of falls, number of injurious falls, fear of falling and activities of daily living (ADL) performance.
3. 3.Characterize intensive tailored home hazard reduction interventions including the frequency of environmental modification by type and location in the home and its direct costs. The investigators will also conduct subgroup analysis of type, location and cost of home modifications by race and gender.

Conditions

Accidental Falls

Keywords

falls in community dwelling older adults; falls and ADL performance; tailored home intervention

Outcome Measures

Primary Outcomes (1)

• Number of falls

  Looking at falls in intervention group and sham group to determine if the intervention group has significantly lower rate of falls.

  The 12-month follow-up phase

Study Arms (2)

Sham intervention

PLACEBO COMPARATOR

Those randomized to the sham or placebo treatment group will receive an "ADL kit" treatment designed only to address fine motor upper extremity function.A series of six 90-minute sessions will be provided to each participant in the sham condition using a standardized protocol.

Other: Sham intervention

Tailored home intervention

EXPERIMENTAL

Those randomized to the study treatment group will receive a tailored home modification intervention delivered in a series of six 90-minute sessions via a standardized protocol. The tailored treatment may include medical equipment and modifications to the home.

Other: Tailored home intervention

Interventions

Tailored home intervention OTHER

The occupational therapist (OT) interventionist will develop a set of environmental modification choices to improve performance in problematic activities identified during the clinical evaluation. A plan for resolving the barriers identified during clinical assessment will be developed. The participant will review the barrier removal options and will make an informed choice resulting in a final treatment plan. Modification installation which will be provided, at no cost to the participant, by a contractor trained by the study PI. The tailored intervention includes training in the use of the new equipment or architectural changes. Photographs of identified barriers, study measures, and intervention plans will be reviewed by the principal investigator during team meetings to ensure treatment fidelity.

Also known as: home modifications and adaptive equipment

Tailored home intervention

Sham intervention OTHER

We have developed a kit containing 12 standard adaptive equipment (AD) items (e.g., jar opener). The AD kit has been specifically designed to address fine motor function and will not influence fall outcomes. Two pieces of AD will be provided during each session, and the individual will be instructed to use each AD by the OT interventionist

Also known as: placebo intervention

Sham intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• include older adults age 65 years or older who have fallen
• include older adults who have limitations in their ADL performance.

You may not qualify if:

• exclude individuals who report falling due to syncope
• exclude individuals who live greater than 30 miles from the hospital
• exclude individuals with substance abuse and dementia.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Occupational Therapy Program at Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Study Officials

• Susan Stark, PhD, OTR/L

  Assistant Professor in Occupational Therapy & Neurology at Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor of Neurology and Occupational Therapy

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 16, 2013
• Study Start: May 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (1)