Trial Outcomes & Findings for Home Evaluation of Exit Barriers in Wandering (NCT NCT00997425)

Last Updated: 2014-11-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

eight weeks

Results posted on

2014-11-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Arm 1 Door Cover; Floor Cover The interventions were provided in the order door cover, then floor cover and then floor cover followed by door cover. After a baseline of 14 days the first Intervention (14 days) was provided, followed by baseline two for another 14 days followed by a second Intervention (14 days).
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home Evaluation of Exit Barriers in Wandering

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 Door Cover; Floor Cover n=19 Participants 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
Age, Continuous	79.9 years STANDARD_DEVIATION 7.89 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: eight weeks

Population: per protocol

Outcome measures

Outcome measures
Measure	Door Cover n=19 Participants \- 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	Floor Cover n=19 Participants 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.-
Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping) Approach (Baseline)	125.2 behavior counts Standard Error 33.63	264.0 behavior counts Standard Error 105.8
Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping) Approach (First Intervention)	245.8 behavior counts Standard Error 148.5	227.8 behavior counts Standard Error 52.9048
Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping) Pass Through (Baseline)	73.07 behavior counts Standard Error 24.41	124.7 behavior counts Standard Error 57.3
Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping) Pass Through (Second Intervention)	105.3 behavior counts Standard Error 68.28	131.1 behavior counts Standard Error 34.8

Adverse Events

Arm 1 Door Cover; Floor Cover

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dorothy H. Moore, PhD

James A. Haley VA Hospital, Tampa, FL

Phone: 813 558-3931

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place