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Emergency Egress and Information System for Persons With Vision Loss

This study has been terminated.
(Intervention worsened performance for first 17 of 24 planned participants.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00262509
First received: December 2, 2005
Last updated: January 14, 2014
Last verified: January 2014
Results First Received: September 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Blindness
Intervention: Device: Egress Badge

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Baseline First, Then Intervention     Intervention First, Then Baseline  
STARTED     8     9  
COMPLETED     8     9  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes groups randomized to do either baseline tests first or Intervention tests first

Reporting Groups
  Description
First Baseline, 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 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

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 Total of all reporting groups

Baseline Measures
    First Baseline, Then Intervention     First Intervention, Then Baseline     Total  
Number of Participants  
[units: participants]
  8     9     17  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     8     16  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  47.78  ± 10.72     52.75  ± 7.07     50.12  ± 9.27  
Gender  
[units: participants]
     
Female     4     4     8  
Male     4     5     9  
Region of Enrollment  
[units: participants]
     
United States     8     9     17  



  Outcome Measures

1.  Primary:   Time to Exit Building   [ Time Frame: 30 minutes total, 15 minutes for each of two timed trials ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Trials were terminated early with just 17 Participants of the planned 24, as the intervention was NOT providing measurable benefit.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David A. Ross
Organization: Atlanta VA Rehabilitation R&D Center of Excellence
phone: 404-321-6111 ext 6817
e-mail: ross0128@bellsouth.net


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00262509     History of Changes
Other Study ID Numbers: C3905-R
Study First Received: December 2, 2005
Results First Received: September 17, 2013
Last Updated: January 14, 2014
Health Authority: United States: Federal Government