Problem Behavior Clinical Trial
Official title:
Home Evaluation of Visual Exit Barriers in Dementia-related Wandering
Main hypothesis. Floor and door visual exit barriers will decrease exit-seeking wandering (exit door approaches) proximal to exit doorways by persons with dementia who wander.
Introduction: Wandering behavior is manifested in ways that include lingering near exit
doors and/or mimicking or "shadowing" the exiting behavior of others who depart through this
door. Referenced as "exit-seeking," such behavior is a common mobility pattern that places
persons with dementia who wander (PDW) at high risk of wandering away or eloping. PDW who
wander away from a care setting unattended are at risk of death from exposure or accidents
if lost and not quickly found, and those that do not wander away but persist in such
behaviors are at risk for falls, fractures and other injuries, weight loss, fatigue and
sleep disturbances. Traditional methods to manage PDW exit-seeking and wandering away
include physical restraints and pharmacology, but these can be harmful. Subjective or
"visual exit barriers" to deter exit-seeking offer an attractive alternative because these
interventions are non-invasive, low-cost and simple to use. Nursing home tests of visual
exit barriers such as plain cloth door covers and stripped floor covers have demonstrated
positive results in reducing or completely exit-seeking 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,
cross-over assignment with randomized allocation 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 exit-seeking wandering patters,
controlling for cognitive impairment? H1. Compared to baseline, installation of a visual
exit barrier will lower the frequency and duration of exit-seeking behaviors. Q2. Of the two
visual barriers (door and floor), which will result in the greater reduction of wandering
(frequency and duration of lingering and shadowing)? H2. Door covers will reduce exit
seeking more than floor covers.
Five secondary questions are proposed for descriptive purposes and to generate hypotheses
for future studies on wandering management interventions. These include: Q3. What are the
baseline characteristics of exit-seeking (predominant loci, durations and variability of
durations during waking hours)? Q4. Will the introduction of a visual barrier on one exit
doorway alter exit-seeking 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 (caregiver) 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 crossover assignment with randomized order of allocation design was used. One
main exit doorway was sequentially protected with the two types (door, floor) of visual
barriers. Data related to exit-seeking of subjects was collected via ultrawide radio
frequency identification devices on a continuous basis for four 14-day periods: Entry into a
monitored zone 6-feet in front of exit doorways will be considered exit-seeking 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. Prior to conducting formal hypothesis testing, an order of
allocation analysis will be completed to determine if carry-over effects occurred in the
study. Analysis (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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Completed |
NCT02855008 -
Steps to Effective Problem Solving in Group Homes
|
N/A | |
Terminated |
NCT02896426 -
Collaborative Problem Solving vs. Positive Solutions for Families in Preschool Parent Groups
|
N/A | |
Completed |
NCT01583127 -
Examining Variation in the Impact of School-Wide Positive Behavioral Interventions and Supports (PBIS)
|
N/A | |
Completed |
NCT06421441 -
The Effect of Self-Management Skills Training Given to Nursing Students According to Peer Education Module on Problematic Internet Use and Academic Procrastination Behavior
|
N/A | |
Terminated |
NCT05445596 -
Improving Treatment for Children With Intellectual and Developmental Disabilities and Problem Behavior in Schools
|
N/A | |
Active, not recruiting |
NCT03683056 -
Mental Health Prevention Among Preschool Children Effectiveness Study
|
N/A | |
Completed |
NCT04097431 -
Identifying Precursors to Severe Problem Behavior
|
N/A | |
Active, not recruiting |
NCT04121650 -
Executive Function and Symptom Reduction in Youth Receiving Home-based Treatment With Collaborative Problem Solving
|
||
Recruiting |
NCT03420339 -
Stimulant Effects on Disruptive Behavior
|
Phase 4 | |
Completed |
NCT03597789 -
Tantrum Tamers 2.0: The Role of Emotion
|
N/A | |
Completed |
NCT05452954 -
Psychosocial ADHD Interventions - Brief Parent Training
|
N/A | |
Completed |
NCT01178554 -
The Clinic Treatment Project
|
N/A | |
Recruiting |
NCT05925101 -
Basic and Applied Research on Extinction Bursts
|
N/A | |
Recruiting |
NCT02945072 -
Clinical Study of Behavior Problems in Children After Different Anesthesia Methods
|
Phase 4 | |
Completed |
NCT02671487 -
Mind-Body Skills Groups for Behavioral and Emotional Problems in War-Traumatized Male Adolescents in Gaza
|
N/A | |
Completed |
NCT04752605 -
Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children
|
N/A | |
Completed |
NCT03736395 -
Scaling up Schoolwide Positive Behavioral Interventions and Supports (SWPBIS) in Rural Idaho Schools
|
N/A | |
Completed |
NCT04888780 -
Effects of Web-Based Training on HbA1c, Quality of Life and Depression Levels in Adolescents With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05260398 -
Examining the Impacts on In-School Behaviors of In-Home Videogame Play
|
N/A |