Deployment Health in Regular Military Women

NCT ID: NCT01692067

Last Updated: 2019-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

871 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Military Physical and Sexual Trauma Combat Trauma PTSD TBI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

D0

Not deployed

No interventions assigned to this group

D1

Deployed to combat-related regions once

No interventions assigned to this group

D2

Deployed to combat related regions more than once

No interventions assigned to this group

D3

Deployed outside of the continental US but not to combat related regions

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

United States Department of Defense

FED

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role collaborator

Iowa City Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anne G SAdler

CADRE Core Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anne G Sadler, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

US Department of Veterans Affairs

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anne G. Sadler, Ph.D.; VAMC

Iowa City, Iowa, United States

Site Status

Iowa City VAMC

Iowa City, Iowa, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GRANT00341283 (USAMRMC)

Identifier Type: -

Identifier Source: secondary_id

DHI08-136 (DVA)

Identifier Type: -

Identifier Source: secondary_id

PT075819

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.