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Trial record 3 of 184 for:    (hispanic OR latina) AND (woman OR women OR female)

Video Decision Aid in Latina Women With Pelvic Organ Prolapse

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ClinicalTrials.gov Identifier: NCT02850835
Recruitment Status : Active, not recruiting
First Posted : August 1, 2016
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Teodoro Ignacio Montoya, Texas Tech University Health Sciences Center, El Paso

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Other: Video Decision Aid Not Applicable

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  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Role of Video Decision Aid in Pelvic Organ Prolapse Treatment Selection in Latina Women
Actual Study Start Date : July 2016
Actual Primary Completion Date : August 17, 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Video Decision Aid
This group will be shown a video decision aid along with their standard of care.
Other: Video Decision Aid
A video decision aid was developed inform patients about pelvic organ prolapse, to include female anatomy, and treatment options.
Other Name: VDA

No Intervention: Standard Care
This group will not see the video decision aid and will only receive standard of care.



Primary Outcome Measures :
  1. Change from baseline decisional conflict score at 6 months. [ Time Frame: 6 months ]
    Decisional Conflict Scale will be used


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850835


Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
Principal Investigator: Teodoro I Montoya, M.D. Texas Tech University Health Sciences Center

Publications:
Responsible Party: Teodoro Ignacio Montoya, Assistant Professor, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT02850835     History of Changes
Other Study ID Numbers: E16059
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Teodoro Ignacio Montoya, Texas Tech University Health Sciences Center, El Paso:
Decision Aid
Pelvic Organ Prolapse (POP)

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical