Home Evaluation of Exit Barriers in Wandering (HEEBW)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00997425
First received: October 15, 2009
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Dementia, Alzheimer Type
Behavior Control
Device: door mat and door camouflage subjective exit barriers
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • decrease in pre-elopement (exit door shadowing and lingering) behavior [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 19
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • veterans over age 60 with an Alzheimer's-like dementia diagnosis, documented in medical record with ICD codes that include all 290 diagnoses and 331.0
  • MMSE 24
  • evidence of pre-elopement behaviors operationalized as scoring 1SD above mean on any one of the three items that comprise the RAWS-CV eloping subscale (#16 - He/she attempts to get outside; #27- He/she stands at the out door wanting to go out; #30- He/she attempts to find or go to familiar locations, even unrealistic ones)
  • living in a non-institutional private family home or foster home
  • independently ambulatory (with or without canes, walkers or wheelchairs to assist)
  • living within a 60-mile radius of the James A. Haley VAMC, Tampa
  • living with a CG who is willing and able to serve as a study partner and provide informant reports, and who intends to be with the PDW for three months (allowing for being away for seven days or less during the three-month study period)
  • English speaking.

Exclusion Criteria:

  • living in a nursing home, group home or assisted living facility at point of entry (foster homes allowed)
  • previous exposure to any visual exit barrier for wandering management
  • no live-in CG
  • bilaterally deaf or blind
  • currently taking anti-psychotic medications
  • current use of any visual exit barrier on any main exit doorway. CG will be allowed to use other wandering management interventions that are not specific to the exit doorways. For example, they may use a stop sign at the entrance to the kitchen, but may not use a stop sign on an experimentally monitored door.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997425

Locations
United States, Florida
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33637-1022
Sponsors and Collaborators
Investigators
Principal Investigator: Dorothy Helen Moore, PhD MA BSW James A. Haley Veterans' Hospital
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00997425     History of Changes
Obsolete Identifiers: NCT00797355
Other Study ID Numbers: E6275-R, 107401 I
Study First Received: October 15, 2009
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
wandering
subjective exit barriers

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014