Completed

ADLThe Effectiveness of a Fall Prevention Program

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What is being tested

Sham intervention

+ Tailored home intervention

Other
Who is being recruted

Over 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: May 2010
See protocol details

Summary

Principal SponsorWashington University School of Medicine
Last updated: August 26, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2010

Actual date on which the first participant was enrolled.

One intervention that has proved successful in improving ADL performance is providing environmental supports such as home modifications. By using environmental support to compensate for the intrinsic limitations this population experiences, ADL and instrumental ADL (IADL) performance can be maximized. In studies of fall causes, environmental features are often identified as an important contributing factor. It is possible that home modifications could be an effective intervention strategy to reduce functional decline, fear of falling, and the incidence falls among older adults with ADL/IADL dysfunction. The consequences of falls in the elderly are a serious public health concern. Older adults who visit an ED as a result of a fall and are discharged home represent an underserved group at great risk for a future fall. The model of screening for older adults at risk for recurrent falls in the ED and initiating interventions is a potentially cost-effective strategy with broad public health implications. Intensive home modifications are an appealing intervention, with high adherence rates and efficacy in improving ADL performance and reducing the rate of falls. There is a need for studies of home modifications. We will conduct a blinded, randomized, sham-controlled pilot trial to estimate the efficacy of an intensive tailored environmental intervention to reduce functional decline among community-dwelling older adults who visit the ED because of a fall. We will also gather the data necessary to design a definitive double-blinded, randomized, sham-controlled clinical trial to determine the efficacy of an intensive tailored environmental intervention to reduce the cumulative incidence of falls in this population. Older adults who visit the ED or contact emergency medical services (EMS)as a result of a fall at home will be randomly assigned to a sham-control or intervention group. The intervention will be delivered via a standardized tailored protocol. Blinded assessments will be conducted of participants' performance before intervention, 6 months after intervention, and 12 months after intervention. Participants will be blinded to treatment group assignment. Upon intervention completion, we will monitor ADL status and falls monthly for 12 months to determine the effect of this intervention over time. Study participants and raters will be blinded to their randomization assignment. The outcome of the study will be masked as improvement in ADL status. This study will be conducted in two phases. Consent and enrollment, evaluation, intervention, and follow-up procedures are the same for both phases of the study. The same measures will be used for both phases of the study.

Principal SponsorWashington University School of Medicine
Last updated: August 26, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

129 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: include older adults age 65 years or older who have fallen include older adults who have limitations in their ADL performance. Exclusion Criteria: 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. (During the initial phase will enroll 40 participants;during the second phase of the study we will enroll 110 participants. The same inclusion and exclusion criteria will be used.) -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
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.

Group II

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Occupational Therapy Program at Washington University School of Medicine

St Louis, United StatesOpen Occupational Therapy Program at Washington University School of Medicine in Google Maps
CompletedOne Study Center