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OpenTrials
Completed

NCT Number: NCT02850835

Video Decision Aid in Latina Women With Pelvic Organ Prolapse

Pelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality of life, daily activities and sexual function. Latina women are disproportionally affected, with significantly higher rates of POP compared to women of other ethnicities. Decision aids have been used to increase patient knowledge prior to physician intervention and to facilitate informed patient participation on treatment selection. The investigators hypothesize that the use of a video decision aid prior to initial Urogynecology specialist evaluation of Latina women with POP in a border region university-affiliated medical clinic, will increase patient knowledge regarding the condition, decrease decisional conflict regarding selection among different treatment options and increase patient satisfaction with selected treatment.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Pelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality of life, daily activities and sexual function. Latina women are disproportionally affected, with significantly higher rates of POP compared to women of other ethnicities. Counseling Latina women suffering from POP is often complex due to a variety of factors, including language barriers, limited patient understanding of anatomy and disease etiology and confusion regarding surgical versus nonsurgical treatment options. Decision aids have been used to increase patient knowledge prior to physician intervention and to facilitate informed patient participation on treatment selection. The investigators hypothesize that the use of a video decision aid prior to initial Urogynecology specialist evaluation of Latina women with POP will increase patient knowledge regarding the condition, decrease decisional conflict regarding selection among different treatment options and increase patient satisfaction with selected treatment, empowering these women as active participants in their healthcare instead of relying on provider input alone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hispanic Women
  • Referred for evaluation of pelvic organ prolapse for the first time

Exclusion criteria

  • Women previously referred or treated for pelvic organ prolapse
  • Women who do not live in El Paso, Texas

Treatment and study plan

Video Decision Aid

Other

A video decision aid was developed inform patients about pelvic organ prolapse, to include female anatomy, and treatment options.

Other names: VDA

Primary outcomes

  1. Change from baseline decisional conflict score at 6 months.

    Time frame: 6 months

    Decisional Conflict Scale will be used

Secondary outcomes

  1. Change from baseline knowledge of condition score at 6 months.

    Time frame: 6 months

    12-item questionnaire of female pelvic anatomy and pelvic organ prolapse concepts will be used

  2. Change from baseline satisfaction with selected treatment at 6 months.

    Time frame: 6 months

    Satisfaction with Decision Scale-(PFD) will be used

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Other

Registry information

Official study title

Role of Video Decision Aid in Pelvic Organ Prolapse Treatment Selection in Latina Women

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 1, 2016
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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