- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02850835
Video Decision Aid in Latina Women With Pelvic Organ Prolapse
April 24, 2019 updated by: Teodoro Ignacio Montoya, Texas Tech University Health Sciences Center, El Paso
Role of Video Decision Aid in Pelvic Organ Prolapse Treatment Selection in Latina Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
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
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
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
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video Decision Aid
This group will be shown a video decision aid along with their standard of care.
|
A video decision aid was developed inform patients about pelvic organ prolapse, to include female anatomy, and treatment options.
Other Names:
|
No Intervention: Standard Care
This group will not see the video decision aid and will only receive standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline decisional conflict score at 6 months.
Time Frame: 6 months
|
Decisional Conflict Scale will be used
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Change from baseline satisfaction with selected treatment at 6 months.
Time Frame: 6 months
|
Satisfaction with Decision Scale-(PFD) will be used
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Teodoro I Montoya, M.D., Texas Tech University Health Sciences 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
- O'Connor AM, Rostom A, Fiset V, Tetroe J, Entwistle V, Llewellyn-Thomas H, Holmes-Rovner M, Barry M, Jones J. Decision aids for patients facing health treatment or screening decisions: systematic review. BMJ. 1999 Sep 18;319(7212):731-4. doi: 10.1136/bmj.319.7212.731.
- Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6. doi: 10.1067/mob.2002.123819.
- Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
- Jelovsek JE, Barber MD. Women seeking treatment for advanced pelvic organ prolapse have decreased body image and quality of life. Am J Obstet Gynecol. 2006 May;194(5):1455-61. doi: 10.1016/j.ajog.2006.01.060.
- Andersen R, Lewis SZ, Giachello AL, Aday LA, Chiu G. Access to medical care among the Hispanic population of the southwestern United States. J Health Soc Behav. 1981 Mar;22(1):78-89. No abstract available.
- Buchsbaum GM, Duecy EE, Kerr LA, Huang LS, Perevich M, Guzick DS. Pelvic organ prolapse in nulliparous women and their parous sisters. Obstet Gynecol. 2006 Dec;108(6):1388-93. doi: 10.1097/01.AOG.0000245784.31082.ed.
- Herman JP, Blangero A, Madelain L, Khan A, Harwood MR. Saccade adaptation as a model of flexible and general motor learning. Exp Eye Res. 2013 Sep;114:6-15. doi: 10.1016/j.exer.2013.04.001. Epub 2013 Apr 15.
- Montoya TI, Rondeau NU, Maldonado PA, Mallett VT. Decision Aid Video for Treatment Selection in Latinas With Symptomatic Pelvic Organ Prolapse: A Randomized Pilot Study. Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):39-45. doi: 10.1097/SPV.0000000000000727.
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)
July 1, 2016
Primary Completion (Actual)
August 17, 2017
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
July 7, 2016
First Submitted That Met QC Criteria
July 29, 2016
First Posted (Estimate)
August 1, 2016
Study Record Updates
Last Update Posted (Actual)
April 26, 2019
Last Update Submitted That Met QC Criteria
April 24, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E16059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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