The Experience of Living With Polycystic Ovary Syndrome in the Military (PCOS)

February 19, 2021 updated by: David Grant U.S. Air Force Medical Center
The purpose of this study is to understand the experience of living with polycystic ovary syndrome (PCOS) as an active duty Service Woman. As part of a budding research program, this proposed study will lay the groundwork for future intervention studies targeting the management of PCOS in a military population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Using a qualitative descriptive approach with focus groups (FG) and individual interviews (II), the investigators will seek to describe the experience of living with PCOS as an active duty service woman (ADSW). This method will allow the investigators to obtain a comprehensive summary of living with PCOS in the every day terms of ADSW. The discussion in the (FG) meetings will be an effective way to supply information about what people think, or how they feel, or on the way they act. Advantages of this method include: (a) it can cover a large number of people in one session, (b) it is an efficient way of gaining a large amount of information in a short time, (c) it is comparatively easier to drive or conduct, and (d) it generates an opportunity to collect data from the group interaction, which concentrates on the topic of the researcher's interest [64, 65].

This proposed study will focus on six primary areas of inquiry: (a) experience of receiving PCOS diagnosis (b) symptoms experienced and methods of coping with them, (c) military-specific experience of managing and living with PCOS, (d) access to/availability of information related to PCOS and how they have applied it, (e) experience of support, and (f) present and future concerns about having PCOS.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Travis Air Force Base, California, United States, 94535
        • David Grant Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Active duty military women diagnosed with PCOS

Description

Inclusion Criteria:

  • Women, active duty or prior (within 5 years) in the Army, Navy, Air Force or Marine Corps
  • Diagnosed with PCOS
  • 18 years of age or over

Exclusion Criteria:

  • Reservist, Coast Guard, women who have separated or retired > 5 years ago

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Focus Group

Active Duty Air Force, Army and Navy women diagnosed with PCOS.

Up to three focus groups per service branch will be conducted. Considering attrition for those who may volunteer and not show up for the FG session, the investigators will recruit up to 20 participants per site, with the goal of including a maximum of six participants per FG to maximize individual participation.
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the PCOS experience of active duty service members
Time Frame: through study completion, up to 18 months
Information from focused groups (FG) discussions and individual interviews (II) will be transcribed, categorized and then organized into themes that describe the experiences of active duty service members
through study completion, up to 18 months
Describe the PCOS experience by branch of service
Time Frame: through study completion, up to 18 months
Information from focused groups (FG) discussions and individual interviews (II) will be transcribed, categorized and then organized into themes that describe the experiences by branch of service
through study completion, up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Grant U.S. Air Force Medical Center

Collaborators

United States Naval Medical Center, San Diego
Malcolm Grow Medical Clinics and Surgery Center
Madigan Army Medical Center

Investigators

  • Principal Investigator: Dawnkimberly Hopkins, PhD, David Grant Medical Center
  • Principal Investigator: Leilani Siaki, PhD, Madigan Army Medical Center
  • Principal Investigator: Abigail Yablonsky, PhD, United States Naval Medical Center, San Diego
  • Principal Investigator: Angela Phillips, PhD, Malcolm Grow Medical Clinics and Surgery Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2019

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH#20200123H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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