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.
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
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.
- Conditions
- Dementia, Alzheimer Type, Problem Behavior
- 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 group | Role | What they receive |
|---|---|---|
| Door Cover/Floor Cover | Experimental | Baseline 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.
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.
- First posted19 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dementia, Alzheimer TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dorothy H Moore, PhD MA BSW, Principal investigator, James A. Haley Veterans' Hospital
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Evaluation of Visual Exit Barriers in Dementia-related Wandering
- ClinicalTrials.gov ID
- NCT00997425
- Acronym / sponsor ID
- HEEBW / E6275-R
- Conditions
- Dementia, Alzheimer Type, Problem Behavior
- Keywords
- wandering, subjective exit barriers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Posted 21 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Door Cover/Floor Cover | Experimental | Device: Door cover/Floor coverBaseline One (14 days), First Intervention (14 days), Baseline Two (14 days), Second Intervention (14 days) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Door cover/Floor coverAlso: subjective exit barriersDoor 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. | Device | Door Cover/Floor Cover |
Primary outcome
Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)
Time frame: eight weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorothy H Moore, PhD MA BSW principal investigator
James A. Haley Veterans' Hospital
1 site in 1 country: see every site and its status.
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.