Deployment Health in Regular Military Women (DHRMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Iowa City Veterans Affairs Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Anne G SAdler, Iowa City Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01692067
First received: July 28, 2011
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition
Military Physical and Sexual Trauma
Combat Trauma
PTSD
TBI

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Combat, Sexual Assault and Post-Traumatic Stress in OIF/OEF Military Women

Resource links provided by NLM:


Further study details as provided by Iowa City Veterans Affairs Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: Months 28-42 of grant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Traumatic brain injury [ Time Frame: Months 28-42 of grant ] [ Designated as safety issue: Yes ]
  • Current internal (e.g. PTSD) and external barriers (e.g. access to care factors)to health services [ Time Frame: Months 28-42 of grant ] [ Designated as safety issue: Yes ]
  • Identification and description of differences between Regular Military and Reserve/National Guard service women for each of these aims (building on currently funded grant). [ Time Frame: Months 28-42 of grant ] [ Designated as safety issue: Yes ]
  • PTSD [ Time Frame: Months 28-42 of Grant ] [ Designated as safety issue: No ]
  • Current medical health, including reproductive health [ Time Frame: Months 28-42 of grant ] [ Designated as safety issue: No ]
  • Deployment factors associated with risk of violence/health [ Time Frame: Months 28-42 of grant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 754
Study Start Date: April 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
D0
Not deployed
D1
Deployed to combat-related regions once
D2
Deployed to combat related regions more than once
D3
Deployed outside of the continental US but not to combat related regions

Detailed Description:

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.

Objectives: 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.

Methods: 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.

Implications: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women and Men who have or are currently serving in the USA regular military.

Criteria

Inclusion Criteria:

  • Focus Group:

    • Men or women who have or are currently active duty regular military (RM) of OIF/OEF service eras (10/7/01- present)
  • Interview phase:

    • Women, who have or are currently serving active duty RM during OIF/OEF service eras

Exclusion Criteria:

  • Focus Group:

    • Disabilities that render incapable of hearing
    • Comprehending
    • Communicating in a group or inhibit travel to focus group
  • Interview phase:

    • Disabilities that render incapable of hearing
    • Comprehending
    • Communicating independently with interviewers by telephone
    • Not having telephone and unable to access a nearby VA or other possible resource to contact toll free number.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692067

Locations
United States, Iowa
Anne G. Sadler, Ph.D.; VAMC
Iowa City, Iowa, United States, 52246
Iowa City VAMC
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
Iowa City Veterans Affairs Medical Center
Investigators
Principal Investigator: Anne G Sadler, Ph.D. Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Anne G SAdler, CADRE Core Investigator, Iowa City Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01692067     History of Changes
Other Study ID Numbers: PT075819, GRANT00341283 (USAMRMC), DHI08-136 (DVA)
Study First Received: July 28, 2011
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by Iowa City Veterans Affairs Medical Center:
Rape
Women
Military
Veterans
Post-traumatic Stress Disorder
Traumatic Brain Injury

ClinicalTrials.gov processed this record on October 23, 2014