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 : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Organ Prolapse||Other: Video Decision Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|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 :||December 31, 2018|
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.
- Change from baseline decisional conflict score at 6 months. [ Time Frame: 6 months ]Decisional Conflict Scale will be used
- 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
- Change from baseline satisfaction with selected treatment at 6 months. [ Time Frame: 6 months ]Satisfaction with Decision Scale-(PFD) will be used
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
|Principal Investigator:||Teodoro I Montoya, M.D.||Texas Tech University Health Sciences Center|