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Dementia, Alzheimer TypeHEEBWNCT00997425

Home Evaluation of Exit Barriers in Wandering

A study testing Door cover/Floor cover in people with Dementia, Alzheimer Type and Problem Behavior, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Dementia, Alzheimer Type, Problem Behavior
What is being tested?
Door cover/Floor cover
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
Oct 2009to Dec 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • veterans age 60 and over with an Alzheimer's-like dementia diagnosis, documented in medical record with International Codes for Diagnosis (ICD-9) codes that include all 290 diagnoses and 331.0
  • Mini Mental State Examination (MMSE) 24 or less
  • evidence of pre-elopement behaviors operationalized as scoring 1 standard deviation (SD) above mean on any one of the three items that comprise the Revised Algase Wandering Scale-Community Version (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 Veterans Administration Medical Center (VAMC), Tampa, Florida
  • living with a caregiver (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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • James A Haley Veterans' Hospital

    Tampa, Florida, 33637-1022

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Door cover/Floor cover
Keywords
wandering, subjective exit barriers
Medical subject headings
Alzheimer Disease, Problem Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Door cover/Floor coverDevice

    Also called subjective exit barriers

    Door cover - a neutral-colored canvas cloth covering the entire interior surface of the monitored door and attached to the door using a combination of Velcro and double-faced tape.

    Floor cover - a 4'X 4' black, rubberized mat with an overlay of very thin strips of 2" white duct tape placed at 2" intervals, nonskid and fastened securely to the floor immediately in front of the interior face of a main exit door.

Study groups in NCT00997425
Study groupRoleWhat they receive
Door Cover/Floor CoverExperimentalBaseline One (14 days), First Intervention (14 days), Baseline Two (14 days), Second Intervention (14 days)
Receives: Device: Door cover/Floor cover

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)

    Door and floor cover interventions were compared for efficacy in reducing wandering behavior defined as patient approaching or passing through the equipped exit door. Counts of each behavior were collected on each patient for each intervention period. Mean values of counts were compared.

    Measured: eight weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionOct 2010
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00997425
Sponsor's protocol ID
E6275-R
Other IDs
107401 I
Acronym
HEEBW
Status last verified
Nov 2014
First submitted
15 Oct 2009
Last updated
21 Nov 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Door cover/Floor cover in people with Dementia, Alzheimer Type and Problem Behavior, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping) (time frame: eight weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.

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