Home Evaluation of Exit Barriers in Wandering

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.