Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032461
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2002-03-20
Brief Title:
Compare the Medical Conditions of Gulf War Veterans to Non-Deployed Veterans
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
National Health Survey of Gulf War Era Veterans and Their Families - Phase III Physical Examinations
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Hypothesis Gulf War veterans will have an equal prevalence or mean level of the following medical and psychological conditions frequently reported in the literature compared to a control group of nondeployed veterans 1 chronic fatigue syndrome 2 fibromyalgia 3 post-traumatic stress disorder 4 neurologic abnormalities including peripheral neuropathy and cognitive dysfunction and 5 general health status
Detailed Description:
1000 Gulf War veterans spouses children and 1000 non-deployed Gulf War era veterans spouses children
Primary Hypothesis Gulf War veterans will have an equal prevalence or mean level of the following medical and psychological conditions frequently reported in the literature compared to a control group of nondeployed veterans 1 chronic fatigue syndrome 2 fibromyalgia 3 post-traumatic stress disorder 4 neurologic abnormalities including peripheral neuropathy and cognitive dysfunction and 5 general health status
Secondary Hypotheses 1 Medical conditions that were reported as more frequent among Gulf War veterans compared to nondeployed veterans in the self-reported data in Phase I will be of equal prevalence in the two groups upon objective clinical examination These include arthritis dermatitis hypertension bronchitis and asthma 2 The prevalence of the above medical conditions in the primary hypotheses and secondary hypothesis 1 will be equal between the spouses of Gulf War veterans and those of nondeployed veterans 3 The prevalence of major birth defects found on a pediatric physical examination of veterans biologic children conceived after the war to Gulf War veterans and nondeployed veterans will be equal the prevalence of medical conditions in children living in the veterans household whether conceived before or after the war for Gulf War veterans and nondeployed veteran will be equal
Intervention This is an observational study
Primary outcomes variables chronic fatigue syndrome post-traumatic stress disorder fibromyalgia peripheral neuropathy cognitive dysfunction and general health status physical component and mental component
Study Abstract In response to a legislative mandate the VA initiated a survey entitled A National Health Survey of Persian Gulf Veterans and Their Families The survey was designed as a retrospective cohort study in which the health of a population-based sample of 15000 troops deployed into the Persian Gulf area was compared to those of 15000 troops not deployed in the Persian Gulf area The survey was to be conducted in three phases In Phase I of the study a structured health questionnaire was mailed to each of the 30000 Persian Gulf War-era veterans who were sampled for the survey Up to four follow-up mailings were sent to non-respondents to increase the response rate in a six-month period In Phase II telephone interviews of a sample of 8000 non-respondents and a review of selected medical records for a sample of 4000 veteran respondents were conducted Through additional telephone interviews with non-respondents the potential for non-participant bias was evaluated The medical records review helped in assessing validity of selected self-reported health data clinic visit hospitalization pregnancy outcomes birth defects among children infant deaths etc
The present protocol represents Phase III of the study--clinical examinations of a sample of 1000 Gulf War GW veterans and their spouses and children and 1000 Gulf War era nondeployed veterans and their spouses and children Results from Phase I indicated that the prevalence of several self-reported health conditions are elevated in the GW veterans compared to the control group The overall purpose of the Phase III study is to corroborate these findings through more objective clinical examination
A sample from a pool of Phase I and Phase II Persian Gulf War veterans and Persian Gulf era nondeployed veterans were generated Dr Kangs office provided the 16 participating medical centers with names and phone numbers of veterans to be contacted Each medical center examined an average of 125 veterans 95 spouses and 123 children over a period of 30 months The VA medical centers were strategically selected so that there was a VA medical center within driving distance of the majority of the families sampled Veterans were contacted first by letter and then by telephone through the site closest to their home and invited to participate in the study Exams were scheduled for the veteran and spousechildren if they were participating Data from these exams were sent to the Hines CSPCC for cleaning and analysis Travel arrangements and expenses were provided for the participants and they were reimbursed for their time
Characteristics of Participants Mean age for deployed veterans who were examined was 389 yrs compared with 407 yrs for non-deployed veterans who were examined p0001 Mean income was 46800 for deployed and 52000 for non-deployed participants p003 Non-deployed participants were more likely to be white 810 vs 764 p03 to be married 723 vs 674 p02 and to continue education past high school 42 vs 325 p0001 Results for Veterans Both the physical and mental component scores derived from the SF-36 were significantly lower among deployed veterans who were examined For the physical component score the mean for the deployed group was 482 sd 98 compared with 508 sd 83 for the non-deployed group p0001 The mental component score averaged 496 sd 102 for the deployed group and 537 sd 79 for the non-deployed group p0001 There was a weak trend for a higher prevalence of fibromyalgia in the deployed group 31 than in the non-deployed group 19 odds ratio 164 95 confidence interval 94 287 p09 There was a higher prevalence of chronic fatigue syndrome among deployed 16 than non-deployed 04 odds ratio 458 95 confidence interval 153 1364 p003 Among the seven cognitive dysfunction factors there was a trend towards a higher prevalence of impaired attentionworking memory among deployed 66 than non-deployed 42 odds ratio 160 95 confidence interval 110 235 p02 PTSD after the Gulf War was more prevalent among deployed 101 than non-deployed participants 32 odds ratio 341 95 confidence interval 230 505 p0001 No differences were found for peripheral neuropathy and 6 of the 7 factors defined to assess cognitive dysfunction Among secondary outcome measures several categories of skin conditions were found to be more prevalent among deployed veterans Results for Spouses The mean score for the mental component scale was lower in the spouses of deployed participants 503 sd 99 than in the spouses of non-deployed participants 526 sd 86 p0001 No other outcome measures for spouses were found to be related to deployment status of the veteran Birth Defects No statistically significant relationship between deployment status and prevalence of birth defects among first live born offspring born after the Gulf War was found Summary Although participation rates were lower than anticipated we found little evidence of participation bias Veterans deployed to the Gulf War have higher rates of chronic fatigue syndrome and post-Gulf War onset PTSD and poorer health-related quality of life Attentionworking memory deficits and fibromyalgia may also be related to deployment to the Gulf War Additional Comments Additional analytic work remains a the results have not been adjusted for covariates such as age b certain subgroups were oversampled and the results are not adjusted for the studys original sampling methodology c analysis of subgroups that are purported to be at increased risk of health impacts due to their type of service in the Gulf War has not been done
Primary Hypothesis Gulf War veterans will have an equal prevalence or mean level of the following medical and psychological conditions frequently reported in the literature compared to a control group of nondeployed veterans 1 chronic fatigue syndrome 2 fibromyalgia 3 post-traumatic stress disorder 4 neurologic abnormalities including peripheral neuropathy and cognitive dysfunction and 5 general health status
Secondary Hypotheses 1 Medical conditions that were reported as more frequent among Gulf War veterans compared to nondeployed veterans in the self-reported data in Phase I will be of equal prevalence in the two groups upon objective clinical examination These include arthritis dermatitis hypertension bronchitis and asthma 2 The prevalence of the above medical conditions in the primary hypotheses and secondary hypothesis 1 will be equal between the spouses of Gulf War veterans and those of nondeployed veterans 3 The prevalence of major birth defects found on a pediatric physical examination of veterans biologic children conceived after the war to Gulf War veterans and nondeployed veterans will be equal the prevalence of medical conditions in children living in the veterans household whether conceived before or after the war for Gulf War veterans and nondeployed veteran will be equal
Intervention This is an observational study
Primary outcomes variables chronic fatigue syndrome post-traumatic stress disorder fibromyalgia peripheral neuropathy cognitive dysfunction and general health status physical component and mental component
Study Abstract In response to a legislative mandate the VA initiated a survey entitled A National Health Survey of Persian Gulf Veterans and Their Families The survey was designed as a retrospective cohort study in which the health of a population-based sample of 15000 troops deployed into the Persian Gulf area was compared to those of 15000 troops not deployed in the Persian Gulf area The survey was to be conducted in three phases In Phase I of the study a structured health questionnaire was mailed to each of the 30000 Persian Gulf War-era veterans who were sampled for the survey Up to four follow-up mailings were sent to non-respondents to increase the response rate in a six-month period In Phase II telephone interviews of a sample of 8000 non-respondents and a review of selected medical records for a sample of 4000 veteran respondents were conducted Through additional telephone interviews with non-respondents the potential for non-participant bias was evaluated The medical records review helped in assessing validity of selected self-reported health data clinic visit hospitalization pregnancy outcomes birth defects among children infant deaths etc
The present protocol represents Phase III of the study--clinical examinations of a sample of 1000 Gulf War GW veterans and their spouses and children and 1000 Gulf War era nondeployed veterans and their spouses and children Results from Phase I indicated that the prevalence of several self-reported health conditions are elevated in the GW veterans compared to the control group The overall purpose of the Phase III study is to corroborate these findings through more objective clinical examination
A sample from a pool of Phase I and Phase II Persian Gulf War veterans and Persian Gulf era nondeployed veterans were generated Dr Kangs office provided the 16 participating medical centers with names and phone numbers of veterans to be contacted Each medical center examined an average of 125 veterans 95 spouses and 123 children over a period of 30 months The VA medical centers were strategically selected so that there was a VA medical center within driving distance of the majority of the families sampled Veterans were contacted first by letter and then by telephone through the site closest to their home and invited to participate in the study Exams were scheduled for the veteran and spousechildren if they were participating Data from these exams were sent to the Hines CSPCC for cleaning and analysis Travel arrangements and expenses were provided for the participants and they were reimbursed for their time
Characteristics of Participants Mean age for deployed veterans who were examined was 389 yrs compared with 407 yrs for non-deployed veterans who were examined p0001 Mean income was 46800 for deployed and 52000 for non-deployed participants p003 Non-deployed participants were more likely to be white 810 vs 764 p03 to be married 723 vs 674 p02 and to continue education past high school 42 vs 325 p0001 Results for Veterans Both the physical and mental component scores derived from the SF-36 were significantly lower among deployed veterans who were examined For the physical component score the mean for the deployed group was 482 sd 98 compared with 508 sd 83 for the non-deployed group p0001 The mental component score averaged 496 sd 102 for the deployed group and 537 sd 79 for the non-deployed group p0001 There was a weak trend for a higher prevalence of fibromyalgia in the deployed group 31 than in the non-deployed group 19 odds ratio 164 95 confidence interval 94 287 p09 There was a higher prevalence of chronic fatigue syndrome among deployed 16 than non-deployed 04 odds ratio 458 95 confidence interval 153 1364 p003 Among the seven cognitive dysfunction factors there was a trend towards a higher prevalence of impaired attentionworking memory among deployed 66 than non-deployed 42 odds ratio 160 95 confidence interval 110 235 p02 PTSD after the Gulf War was more prevalent among deployed 101 than non-deployed participants 32 odds ratio 341 95 confidence interval 230 505 p0001 No differences were found for peripheral neuropathy and 6 of the 7 factors defined to assess cognitive dysfunction Among secondary outcome measures several categories of skin conditions were found to be more prevalent among deployed veterans Results for Spouses The mean score for the mental component scale was lower in the spouses of deployed participants 503 sd 99 than in the spouses of non-deployed participants 526 sd 86 p0001 No other outcome measures for spouses were found to be related to deployment status of the veteran Birth Defects No statistically significant relationship between deployment status and prevalence of birth defects among first live born offspring born after the Gulf War was found Summary Although participation rates were lower than anticipated we found little evidence of participation bias Veterans deployed to the Gulf War have higher rates of chronic fatigue syndrome and post-Gulf War onset PTSD and poorer health-related quality of life Attentionworking memory deficits and fibromyalgia may also be related to deployment to the Gulf War Additional Comments Additional analytic work remains a the results have not been adjusted for covariates such as age b certain subgroups were oversampled and the results are not adjusted for the studys original sampling methodology c analysis of subgroups that are purported to be at increased risk of health impacts due to their type of service in the Gulf War has not been done
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None