Prospective Study of Veteran Health in Previously Deployed Soldiers

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00285246
• Collaborator: (none)
• Enrollment: 838
• Locations: 2
• Duration (Months): 62
• Patients Per Site: 419
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief Summary

Background: Previous deployments like that to the Persian Gulf in 1991 produced veterans with post-deployment symptom-based health problems with no medical explanation. This was termed Gulf War illness or medically unexplained illness (MUI). If previous wars are any indication, some soldiers currently deployed to hostile areas also will return home with unexplained symptom-based illnesses. However, when this study began there was virtually no pre-war, prospective data on risk and resilience factors associated with MUI. This study is attempting to fill that gap.

Objectives: Our goals are to: (a) determine pre- and immediate post-deployment factors predicting later MUI and poor functional status, (b) improve previous methodological problems (e.g., selection bias, recall bias and lack of baseline controls) in studies of MUI, and (c) relate pre-deployment risk factors (e.g., personality, stressor reactivity) and resilience factors (e.g., coping style, social support) to post-deployment functional status.

Condition or Disease	Intervention/Treatment	Phase
Combat Disorders

Detailed Description

Background: Previous deployments like that to the Persian Gulf in 1991 produced veterans with post-deployment symptom-based health problems with no medical explanation. This was termed Gulf War illness or medically unexplained illness (MUI). If previous wars are any indication, some soldiers currently deployed to hostile areas also will return home with unexplained symptom-based illnesses. However, was virtually no pre-war, prospective data on risk and resilience factors associated with MUI before 2001. This study will attempt to fill that gap. Objectives: Our goals are to: (a) determine pre- and immediate post-deployment factors predicting later MUI and poor functional status, (b) improve previous methodological problems (e.g., selection bias, recall bias and lack of baseline controls) in studies of MUI, and (c) relate pre-deployment risk factors (e.g., personality, stressor reactivity) and resilience factors (e.g., coping style, social support) to post-deployment functional status. Methods: This study uses a prospective, longitudinal observational design to assess risk and resilience factors for post-war MUI in Reserve and National Guard enlisted personnel. A stratified random sample of more than 700 subjects will be drawn from those undergoing pre- and post-mobilization readiness processing at Fort Dix, NJ and Camp Shelby, MS. Personnel will be tested pre-mobilization (Phase 1), immediately after mobilization (Phase 2) and at 3 months and 1 year post-deployment (Phases 3 & 4). Predictor variables include personality, social support, coping style, non-specific symptoms, sympathetic cardiac stress reactivity, and cortisol stress reactivity. Control variables include prior traumatic events, current distress, PTSD symptoms, socially desirable responding, body mass index, deployment experiences, environmental exposures and demographics (e.g., age, gender). Outcome variables include functional status, healthcare utilization, and MUI status (using CDC criteria for chronic multisymptom illness developed after the first Gulf War). Status: Publications and presentations are being prepared. Impact: The larger, prospective study with soldiers will help us to identify pre- and early post-deployment risk and resilience factors important in MUI, functional status, and healthcare utilization. There is an urgent need for both pre- and post-deployment predictors of later MUI uncontaminated by recall bias, and the selection bias of studying only treatment-seekers. If we are to understand how to best treat veterans presenting with unexplained symptoms, then we need to know which pre-war factors are most useful in predicting who is most likely to be resilient and who is most likely to be at risk for later unexplained illness.

Study Design

• Study Type: Observational
• Actual Enrollment: 838 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Study of Functional Status in Veterans at Risk for Unexplained Illnesses
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS

Outcome Measures

Primary Outcome Measures

1. Non-Specific Physical Symptoms [pre-deployment (Phase 1), immediately post-deployment (Phase 2), 3 months post-return from deployment (Phase 3), 1 year post-return from deployment (Phase 4)]

   Severity of non-specific physical symptoms from the 15 item Patient Health Questionnaire-15 (Kroenke, Spitzer & Williams, 2002). Scale score range is 0-30. Higher scores indicate greater non-specific physical symptom severity. This scale does not contain subscales.

2. Physical Functional Status [pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)]

   Physical Component Summary Score (PCS) from the Veterans RAND (VR) 36 measure (Kazis, 2000). Composite scores are normed to a mean of 50 and a SD of 10. Scores can range from 0-100. Higher scores indicate better physical function.

3. Mental Functional Status [pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return]

   Mental Component Summary Score (MCS) from the Veterans-RAND (VR) 36 (Kazis, 2000). MCS is a composite score with a mean of 50 and a standard deviation of 10. Scale scores range from 0-100 with higher scores reflecting better mental function.

4. Health Care Utilization [pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)]

   This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, New Jersey (NJ) and Camp Shelby, Mississippi (MS)

Exclusion Criteria:

• There are some drug exclusions for anything that substantially affects cardiovascular function.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS	Jackson	Mississippi	United States	39216
2	East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ	East Orange	New Jersey	United States	07018

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Karen S. Quigley, PhD, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00285246
• Other Study ID Numbers: IIR 02-296
• First Posted: Feb 1, 2006
• Last Update Posted: May 12, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by US Department of Veterans Affairs: combat disorders; stress, psychological; somatoform disorders; life change events; utilization
• Additional relevant MeSH terms: Combat Disorders

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Period Title: Overall Study
STARTED	838
COMPLETED	790
NOT COMPLETED	48

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Overall Participants	838
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.9 (8.3)
Sex: Female, Male (Count of Participants)
Female	96 11.5%
Male	742 88.5%
Race/Ethnicity, Customized (participants) [Number]
White/Causasian	564 67.3%
Hispanic/Latino	33 3.9%
Black/African American/Non-Hispanic	72 8.6%
Black/African American/Hispanic	1 0.1%
Asian	12 1.4%
Native Hawaiian or other Pacific Islander	10 1.2%
American Indian or Alaskan Native	46 5.5%
Unknown/Not Provided	100 11.9%
Region of Enrollment (participants) [Number]
United States	838 100%

Outcome Measures

1. Primary Outcome

Title	Non-Specific Physical Symptoms
Description	Severity of non-specific physical symptoms from the 15 item Patient Health Questionnaire-15 (Kroenke, Spitzer & Williams, 2002). Scale score range is 0-30. Higher scores indicate greater non-specific physical symptom severity. This scale does not contain subscales.
Time Frame	pre-deployment (Phase 1), immediately post-deployment (Phase 2), 3 months post-return from deployment (Phase 3), 1 year post-return from deployment (Phase 4)

Outcome Measure Data

Analysis Population Description

Not all of the 790 completers has complete data on the non-specific physical symptoms measure.

Arm/Group Title	All Participants
Arm/Group Description	Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Measure Participants	767
Phase 1	5.2 (3.9)
Phase 2	7.9 (4.9)
Phase 3	7.7 (5.1)
Phase 4	7.7 (5.4)

2. Primary Outcome

Title	Physical Functional Status
Description	Physical Component Summary Score (PCS) from the Veterans RAND (VR) 36 measure (Kazis, 2000). Composite scores are normed to a mean of 50 and a SD of 10. Scores can range from 0-100. Higher scores indicate better physical function.
Time Frame	pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)

Outcome Measure Data

Analysis Population Description

Not all of the 790 completers has complete data on this physical functional status measure.

Arm/Group Title	All Participants
Arm/Group Description	Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Measure Participants	762
Phase 1	55.5 (5.2)
Phase 2	53.7 (6.9)
Phase 3	52.8 (7.6)
Phase 4	51.5 (8.8)

3. Primary Outcome

Title	Mental Functional Status
Description	Mental Component Summary Score (MCS) from the Veterans-RAND (VR) 36 (Kazis, 2000). MCS is a composite score with a mean of 50 and a standard deviation of 10. Scale scores range from 0-100 with higher scores reflecting better mental function.
Time Frame	pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return

Outcome Measure Data

Analysis Population Description

Not all of the 790 completers has complete data on the mental functional status measure.

Arm/Group Title	All Participants
Arm/Group Description	Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Measure Participants	762
Phase 1	48.0 (9.1)
Phase 2	45.7 (10.7)
Phase 3	45.0 (11.5)
Phase 4	44.9 (12.4)

4. Primary Outcome

Title	Health Care Utilization
Description	This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.
Time Frame	pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)

Outcome Measure Data

Analysis Population Description

Not all of the 790 completers has complete data on the healthcare utilization measure.

Arm/Group Title	All Participants
Arm/Group Description	Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Measure Participants	752
Phase 1	0.78 (0.87)
Phase 2	0.68 (0.81)
Phase 3	0.69 (0.74)
Phase 4	1.11 (0.97)

Adverse Events

Time Frame	Data were collected at all 4 time points (pre-deployment=Phase 1, immediate post-deployment=Phase 2, 3 months post-deployment=Phase 3, one year post-deployment=Phase 4). The entire duration was about 2 years given an average deployment of about one year.
Arm/Group Title	All Participants
Arm/Group Description	Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/838 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/838 (0%)

Limitations/Caveats

The sample was comprised of only Army National Guard and Reserve military personnel, and therefore results may not generalize to the broader population of military personnel from other Service branches or components.

More Information

Certain Agreements

All Principal Investigators ARE 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.