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Service and Health During the Iraq and Afghanistan Era (CSP #595 Pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987401
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition Iraq and Afghanistan Era Veterans
Enrollment 1242
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mailed Survey Telephone Survey In-person Survey
Hide Arm/Group Description Participants who received the survey by mail. Participants who received the survey by telephone. Participants who received survey in person.
Period Title: Overall Study
Started 591 591 60
Completed 137 121 16
Not Completed 454 470 44
Arm/Group Title Mail Phone In-Person Total
Hide Arm/Group Description Received mail survey Received phone survey Invited to in-person survey Total of all reporting groups
Overall Number of Baseline Participants 591 591 60 1242
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 591 participants 591 participants 60 participants 1242 participants
38.2  (10.9) 39.4  (11.5) 36.7  (10.6) 38.7  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 591 participants 591 participants 60 participants 1242 participants
Female
87
  14.7%
93
  15.7%
8
  13.3%
188
  15.1%
Male
504
  85.3%
498
  84.3%
52
  86.7%
1054
  84.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 591 participants 591 participants 60 participants 1242 participants
American Indian or Alaska Native
5
   0.8%
5
   0.8%
0
   0.0%
10
   0.8%
Asian
24
   4.1%
22
   3.7%
3
   5.0%
49
   3.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
89
  15.1%
97
  16.4%
3
   5.0%
189
  15.2%
White
452
  76.5%
449
  76.0%
51
  85.0%
952
  76.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
21
   3.6%
18
   3.0%
3
   5.0%
42
   3.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 591 participants 591 participants 60 participants 1242 participants
591 591 60 1242
1.Primary Outcome
Title Participation Rates
Hide Description From the national sample, the investigators will compare participation rates for the mailed survey and telephone survey. Among a sample of Veterans living in the greater Boston area, the investigators will calculate participation rate for the in-person survey.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mailed Survey Telephone Survey In-person Survey
Hide Arm/Group Description:
Participants who received the survey by mail.
Participants who received the survey by telephone.
Participants who received survey in person.
Overall Number of Participants Analyzed 591 591 60
Measure Type: Count of Participants
Unit of Measure: Participants
137
  23.2%
121
  20.5%
14
  23.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mailed Survey Telephone Survey In-person Survey
Hide Arm/Group Description Participants who received the survey by mail. Participants who received the survey by telephone. Participants who received survey in person.
All-Cause Mortality
Mailed Survey Telephone Survey In-person Survey
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/591 (0.00%)   0/591 (0.00%)   0/60 (0.00%) 
Hide Serious Adverse Events
Mailed Survey Telephone Survey In-person Survey
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/591 (0.00%)   0/591 (0.00%)   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mailed Survey Telephone Survey In-person Survey
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/591 (0.00%)   0/591 (0.00%)   0/60 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nicholas L. Smith, Director of Seattle Cooperative Studies Program
Organization: Department of Veterans Affairs, Office of Research and Development
Phone: 2067642773
EMail: nicholas.smith@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01987401    
Other Study ID Numbers: 595Pilot
First Submitted: November 12, 2013
First Posted: November 19, 2013
Results First Submitted: May 23, 2017
Results First Posted: September 12, 2018
Last Update Posted: September 12, 2018