Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01833182 |
| Other study ID # |
MOLHH0196-09 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2010 |
| Est. completion date |
June 2014 |
Study information
| Verified date |
July 2023 |
| Source |
Washington University School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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. 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.
Hypothesis 1: The cumulative incidence of falls over 12 months will be lower for the
intensive tailored home hazard removal group compared to the sham control group.
The secondary aims of the proposed study are to:
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.
Hypothesis 2: The investigators hypothesize that the intensive tailored home hazard
reduction intervention group will experience fewer total falls, fewer injurious falls,
less fear of falling and improved ADL performance compared to the sham control group.
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.
The proposed study is innovative because it provides intensive, individualized prescriptions
of home hazard removal and because it provides a quick response to a fall. It is also the
first double-blind trial of the effect of environmental modification on falls and, to our
knowledge, is the first collaboration between occupational therapy and emergency medicine on
fall reduction strategies in the US.
The results of the proposed study will provide new evidence about the effectiveness of
intensive tailored home hazard removal to reduce falls. This study has the potential to
provide public health guidelines for the delivery of home hazard removal, decrease the health
care costs associated with falls and to provide evidence for guiding public health policy for
older adults who have fallen.
Description:
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.
