ADLThe Effectiveness of a Fall Prevention Program
Sham intervention
+ Tailored home intervention
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.129 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalStudy 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