Trial Outcomes & Findings for Emergency Egress and Information System for Persons With Vision Loss (NCT NCT00262509)
NCT ID: NCT00262509
Last Updated: 2014-02-11
Results Overview
Subjects are walked into a building to a specific location and then asked to find their way out of the building. Time to Exit Building is measured. This is protocol is performed twice, and the times averaged to obtain the outcome measure.
TERMINATED
NA
17 participants
30 minutes total, 15 minutes for each of two timed trials
2014-02-11
Participant Flow
Subjects were recruited from July through September, 2009. They were recruited from the VA Medical Center Eye Clinic and the Atlanta Center for Visual Impairment.
17 participants recruited after 23 potential participants contacted by phone from our VA subject registry. Of the 23 contacted, 3 screened out as not meeting inclusion criteria, and 3 chose not to participate.
Participant milestones
| Measure |
Baseline First, Then Intervention
Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes.
Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes.
|
Intervention First, Then Baseline
Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes.
Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Emergency Egress and Information System for Persons With Vision Loss
Baseline characteristics by cohort
| Measure |
First Baseline, Then Intervention
n=8 Participants
Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes.
Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes.
|
First Intervention, Then Baseline
n=9 Participants
Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes.
Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
47.78 years
STANDARD_DEVIATION 10.72 • n=99 Participants
|
52.75 years
STANDARD_DEVIATION 7.07 • n=107 Participants
|
50.12 years
STANDARD_DEVIATION 9.27 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
17 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 minutes total, 15 minutes for each of two timed trialsPopulation: Total number of participants completing study
Subjects are walked into a building to a specific location and then asked to find their way out of the building. Time to Exit Building is measured. This is protocol is performed twice, and the times averaged to obtain the outcome measure.
Outcome measures
| Measure |
Intervention
n=17 Egress Time
All Blind Participants are trained for 15 minutes in the use of the egress device, then for two separate trials are walked into a building to a specific location, and are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is obtained by averaging the two trial times
|
Baseline
n=17 Egress Time
All Blind Participants, in two separate trials, are walked into a building to a specific location, and then are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is calculated as the average of the trial times.
|
|---|---|---|
|
Time to Exit Building
|
198 seconds
Standard Deviation 47
|
165 seconds
Standard Deviation 63
|
Adverse Events
Egress Badge Intervention
Baseline Egress
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David A. Ross
Atlanta VA Rehabilitation R&D Center of Excellence
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place