Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT01692067
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2011-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deployment Health in Regular Military Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082002', 'term': 'Sexual Trauma'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 871}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-18', 'studyFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Organizational, situational, and individual risk factors for physical and sexual assault in women who have or currently serving in active duty Regular Military in OIF/OEF by deployment status.', 'timeFrame': 'Months 28-42 of grant'}], 'secondaryOutcomes': [{'measure': 'Traumatic brain injury', 'timeFrame': 'Months 28-42 of grant'}, {'measure': 'Current internal (e.g. PTSD) and external barriers (e.g. access to care factors)to health services', 'timeFrame': 'Months 28-42 of grant'}, {'measure': 'Identification and description of differences between Regular Military and Reserve/National Guard service women for each of these aims (building on currently funded grant).', 'timeFrame': 'Months 28-42 of grant'}, {'measure': 'PTSD', 'timeFrame': 'Months 28-42 of Grant'}, {'measure': 'Current medical health, including reproductive health', 'timeFrame': 'Months 28-42 of grant'}, {'measure': 'Deployment factors associated with risk of violence/health', 'timeFrame': 'Months 28-42 of grant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rape', 'Women', 'Military', 'Veterans', 'Post-traumatic Stress Disorder', 'Traumatic Brain Injury'], 'conditions': ['Military Physical and Sexual Trauma', 'Combat Trauma', 'PTSD', 'TBI']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine potential risk factors for physical and sexual assault in regular military women (as opposed to Reserve and National Guard). In addition, this study seeks to determine associations between service women's violence exposures and: current physical and mental health status (e.g. PTSD), and access to and use of DoD, DVA and civilian healthcare.", 'detailedDescription': "Background: The proposed study of Regular Military service women builds on and extends a funded VA HSR\\&D grant currently investigating similar objectives in Reserves and National Guard (R/NG) service women. This proposed study addresses the radically changing DoD and DVA health care delivery needs of two priority populations: women exposed to combat, and women sexually assaulted during military. There is a limited understanding of the complex relationship between these traumatic exposures and women's health outcomes, such as post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) and with their subsequent health service use or barriers to care.\n\nObjectives: The objectives are: 1) To identify and describe organizational, situational, and individual risk factors for physical and sexual assault (i.e., victimization) in women who have served or are currently serving in the Regular Military in Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) by deployment status (those who are deployed to combat related regions once, those deployed more than once, those serving in non-combat related areas outside of the continental United States (US), or those serving within the continental US. 2) To determine associations between PTSD, TBI, and physical and sexual assault during OEF/OIF with current physical and mental health status and health risk behaviors by deployment status. 3) To identify current internal and external barriers to DoD, DVA, and civilian health services in relationship to women's deployment and victimization status and the association between PTSD and TBI; 4) To identify and describe differences between Regular Military and R/NG populations for each of these objectives.\n\nMethods: We propose a cross sectional study design with two sequential phases. Phase 1 would include focus groups to refine the current study interview specific to Regular Military populations. Phase 2 would involve the identification and successful interviewing of 669 Regular Military service women, using random sampling with stratification by deployment status, state of service accession, and service branch. Building on our current study, women will be selected from five states: Iowa, Illinois, Kansas, Missouri, and Nebraska. Potential study participants will be mailed an information summary and asked to take part in a study assessing the deployment health of military women. 1058 women will be contacted to obtain the target of 669 completed interviews. Consenting participants (167 per deployment group) will complete a telephone interview that assesses socio-demographic variables, trauma exposures, health history, current health status, military environmental factors (organizational and situational factors), military and DVA health care and barriers to this care, and self reported service use. Descriptive analysis and multiple logistic regression analysis will be used.\n\nImplications: It is unclear if the needs of military women are met by current combat-associated PTSD treatments originally based on male populations. It is anticipated that our findings will improve understanding of the health risks and outcomes of deployed Regular Military service women in contrast to women serving in the R/NG (with PTSD and TBI as key outcome variables). Our results consequently will have implications for DoD and DVA evidence based interventions for both primary prevention and care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women and Men who have or are currently serving in the USA regular military.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Focus Group:\n\n * Men or women who have or are currently active duty regular military (RM) of OIF/OEF service eras (10/7/01- present)\n* Interview phase:\n\n * Women, who have or are currently serving active duty RM during OIF/OEF service eras\n\nExclusion Criteria:\n\n* Focus Group:\n\n * Disabilities that render incapable of hearing\n * Comprehending\n * Communicating in a group or inhibit travel to focus group\n* Interview phase:\n\n * Disabilities that render incapable of hearing\n * Comprehending\n * Communicating independently with interviewers by telephone\n * Not having telephone and unable to access a nearby VA or other possible resource to contact toll free number.'}, 'identificationModule': {'nctId': 'NCT01692067', 'acronym': 'DHRMS', 'briefTitle': 'Deployment Health in Regular Military Women', 'organization': {'class': 'FED', 'fullName': 'Iowa City Veterans Affairs Medical Center'}, 'officialTitle': 'Combat, Sexual Assault and Post-Traumatic Stress in OIF/OEF Military Women', 'orgStudyIdInfo': {'id': 'PT075819'}, 'secondaryIdInfos': [{'id': 'GRANT00341283 (USAMRMC)'}, {'id': 'DHI08-136 (DVA)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'D0', 'description': 'Not deployed'}, {'label': 'D1', 'description': 'Deployed to combat-related regions once'}, {'label': 'D2', 'description': 'Deployed to combat related regions more than once'}, {'label': 'D3', 'description': 'Deployed outside of the continental US but not to combat related regions'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52246', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Anne G. Sadler, Ph.D.; VAMC', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '52246', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa City VAMC', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Anne G Sadler, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'US Department of Veterans Affairs'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iowa City Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CADRE Core Investigator', 'investigatorFullName': 'Anne G SAdler', 'investigatorAffiliation': 'Iowa City Veterans Affairs Medical Center'}}}}