Home Evaluation of Exit Barriers in Wandering (HEEBW)
Main hypothesis. Floor and door visual exit barriers will decrease the frequency and duration of pre-elopement behaviors (lingering and shadowing) proximal to exit doorways, thus supporting the ability of caregivers to provide safe care at home and preventing or delaying home-to-institutional transfer of veterans with dementia who wander.
Dementia, Alzheimer Type
Device: door mat and door camouflage subjective exit barriers
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Home Evaluation of Visual Exit Barriers in Dementia-related Wandering|
- decrease in pre-elopement (exit door shadowing and lingering) behavior [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
- reduction in caregiver (CG) burden [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
- increase in pre-elopement behaviors occurring in proximity to other potential exit doors and windows within the same area [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
- increase in persons with dementia agitation [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Device: door mat and door camouflage subjective exit barriers
Door mat - a 4'X 4' black, rubberized mat with an overlay of very thin strips of 2" white duct tape placed at 2" intervals. To avoid introducing a tripping hazard, the mat will be nonskid and will be fastened securely to the floor. Door covers - a neutral-colored canvas cloth that cover the entire interior surface of the door and is attached to the door using a combination of Velcro and double-faced tape
Introduction: Pre-elopement behavior, or lingering near exit doors and mimicking or "shadowing" the exiting behavior of others who depart through this door, is a common and high risk mobility pattern of persons with dementia who wander (PDW). PDW who successfully leave a care setting unattended (elope) are at risk of death from exposure or accidents if lost and not quickly found, and those that do not successfully elope but persist in pre-elopement behaviors are at risk for falls, fractures and other injuries, weight loss, fatigue and sleep disturbances. Traditional methods to manage PDW pre-elopement and elopement behavior include physical restraints and pharmacology, but these can be harmful. Subjective visual exit barriers to prevent pre-elopement and elopement behaviors offer an attractive alternative because they are non-invasive, low-cost, simple to use. Nursing home tests of visual exit barriers such as door covers and floor mats bearing stripe patterns have demonstrated positive results in reducing or completely eliminating pre-elopement and elopement behaviors. Confirmation of these results in a well designed, home-based trial is warranted.
Research Questions/Hypotheses: The research questions and hypotheses of this 2-year, one group cross-over repeated measures design with two intervention and two no-intervention periods (at baseline and after the first intervention) are: Q1. Will installation of visual barrier interventions change pre-elopement behaviors, controlling for cognitive impairment? H1. Compared to baseline, installation of a visual exit barrier will lower the frequency and duration of pre-elopement behaviors. Q2. Of the two visual barriers (door and floor), which will result in the greater reduction of pre-elopement behaviors (frequency and duration of lingering and shadowing)? H2. Door covers will reduce pre-elopement behaviors more than floor mats.
Five secondary questions are proposed for descriptive purposes and to generate hypotheses for future studies that evaluate the effectiveness of wandering management interventions. These include: Q3. What are the baseline characteristics of pre-elopement behaviors (predominant loci, durations and variability of durations during waking hours)? Q4. Will the introduction of a visual barrier on one exit doorway alter pre-elopement behaviors occurring in proximity to other potential exit doors and windows within the same area? Q5. Will the introduction of visual exit barriers reduce CG burden? Q6. Will the introduction of visual exit barriers increase PDW agitation? and Q7. How do CG rate visual barrier effectiveness and acceptability for in-home use?
Methods: A one group cross-over repeated measures design with two intervention and two no-intervention periods (at baseline and after the first intervention) will be used. One main exit doorway will be sequentially protected with the two types of visual barriers. Data related to pre-elopement behavior of subjects will be collected via radio frequency identification on a continuous basis for four 15-day periods. Entry into a monitored zone 6-feet in front of exit doorways will be considered pre-elopement behavior; PDW locomotion in tandem with CG locomotion will be considered shadowing. Caregiver-reported PDW agitation and CG burden will be collected at baseline and immediate post-interventions. Prior to all statistical analysis, all variables will be reviewed for valid data points and normalcy for continuous data. Should erroneous data points exist, data will be verified to ensure accuracy. Should data not be normally distributed, processes such as transformations or truncations will be completed. Although we expect that randomization process of interventions to work, prior to conducting formal hypothesis testing, analysis will be completed to determine if period effects as well as carry-over effects occurred in the study. Analysis as outlined by Pocock will be completed, which in essence examines the mean of differences by use of t-statistics. In addition, intent to treat analysis will be completed. Given we have incorporated a second baseline phase into the study, frequency and duration will be compared between the two baseline phases to ensure consistency. Descriptive statistics (frequency distributions for categorical variables, means and standard deviations for continuous variables) will be calculated for all baseline variables including the covariates. Main hypothesis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997425
|United States, Florida|
|James A. Haley Veterans' Hospital|
|Tampa, Florida, United States, 33637-1022|
|Principal Investigator:||Dorothy Helen Moore, PhD MA BSW||James A. Haley Veterans' Hospital|