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Home Evaluation of Exit Barriers in Wandering

Home Evaluation of Visual Exit Barriers in Dementia-related Wandering

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00997425
Acronym
HEEBW
Enrollment
19
Registered
2009-10-19
Start date
2009-10-31
Completion date
2012-12-31
Last updated
2014-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Alzheimer Type, Problem Behavior

Keywords

wandering, subjective exit barriers

Brief 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.

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.

Interventions

DEVICEDoor cover/Floor cover

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.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)eight weeksDoor 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.

Countries

United States

Participant flow

Recruitment details

Recruitment of veteran with dementia/caregiver subject dyads included face-to-face recruitment at 2 medical clinics within the same VA hospital and opt out letters mailed to the homes veterans and caregiver participants in a VA-sponsored Alzheimer's Association Safe return program.

Participants by arm

ArmCount
Arm 1 Door Cover; Floor Cover
Floor cover - a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door. Door cover - a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape
19
Total19

Baseline characteristics

CharacteristicArm 1 Door Cover; Floor Cover
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
19 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous79.9 years
STANDARD_DEVIATION 7.89
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
15 Participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
17 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 19
serious
Total, serious adverse events
0 / 19

Outcome results

Primary

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.

Time frame: eight weeks

Population: per protocol

ArmMeasureGroupValue (MEAN)Dispersion
Door CoverNumber and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)Approach (Baseline)125.2 behavior countsStandard Error 33.63
Door CoverNumber and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)Approach (First Intervention)245.8 behavior countsStandard Error 148.5
Door CoverNumber and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)Pass Through (Baseline)73.07 behavior countsStandard Error 24.41
Door CoverNumber and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)Pass Through (Second Intervention)105.3 behavior countsStandard Error 68.28
Floor CoverNumber and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)Pass Through (Second Intervention)131.1 behavior countsStandard Error 34.8
Floor CoverNumber and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)Approach (Baseline)264.0 behavior countsStandard Error 105.8
Floor CoverNumber and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)Pass Through (Baseline)124.7 behavior countsStandard Error 57.3
Floor CoverNumber and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)Approach (First Intervention)227.8 behavior countsStandard Error 52.9048
p-value: 0.098paired t-test
p-value: 0.045paired t-test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026