Home Evaluation of Exit Barriers in Wandering

NCT00997425 | Completed Results

• 2 other identifiers: E6275-R107401 I
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia, Alzheimer Type; Problem Behavior

Keywords

wandering; subjective exit barriers

Outcome Measures

Primary Outcomes (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.

  eight weeks

Study Arms (1)

Door Cover/Floor Cover

EXPERIMENTAL

Baseline One (14 days), First Intervention (14 days), Baseline Two (14 days), Second Intervention (14 days)

Device: Door cover/Floor cover

Interventions

Door cover/Floor cover DEVICE

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.

Also known as: subjective exit barriers

Door Cover/Floor Cover

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

James A Haley Veterans' Hospital

Tampa, Florida, 33637-1022, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Problem Behavior

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Limitations and Caveats

Radio Frequency Identification Device measurement method cumbersome and obtrusive; small sample size (n=19). Further investigation is necessary in order to draw conclusions about visual barriers deterring wandering defined as exit door approaching.

Results Point of Contact

• Title: Dorothy H. Moore, PhD
• Organization: James A. Haley VA Hospital, Tampa, FL

Dorothy.Moore4@va.gov

813 558-3931

Study Officials

• Dorothy H Moore, PhD MA BSW

  James A. Haley Veterans' Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 19, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2012
• Last Updated: November 21, 2014
• Results First Posted: November 21, 2014

Record last verified: 2014-11

Locations

US (1)