Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-01 @ 2:44 PM
Study NCT ID:
NCT02850835
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2016-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Decision Aid in Latina Women With Pelvic Organ Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2016-07-07', 'studyFirstSubmitQcDate': '2016-07-29', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline decisional conflict score at 6 months.', 'timeFrame': '6 months', 'description': 'Decisional Conflict Scale will be used'}], 'secondaryOutcomes': [{'measure': 'Change from baseline knowledge of condition score at 6 months.', 'timeFrame': '6 months', 'description': '12-item questionnaire of female pelvic anatomy and pelvic organ prolapse concepts will be used'}, {'measure': 'Change from baseline satisfaction with selected treatment at 6 months.', 'timeFrame': '6 months', 'description': 'Satisfaction with Decision Scale-(PFD) will be used'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Decision Aid', 'Pelvic Organ Prolapse (POP)'], 'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '19935030', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17138771', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12066091', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '16647928', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7240708', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23597598', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10487995', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '31008776', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hispanic Women\n* Referred for evaluation of pelvic organ prolapse for the first time\n\nExclusion Criteria:\n\n* Women previously referred or treated for pelvic organ prolapse\n* Women who do not live in El Paso, Texas'}, 'identificationModule': {'nctId': 'NCT02850835', 'briefTitle': 'Video Decision Aid in Latina Women With Pelvic Organ Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University Health Sciences Center, El Paso'}, 'officialTitle': 'Role of Video Decision Aid in Pelvic Organ Prolapse Treatment Selection in Latina Women', 'orgStudyIdInfo': {'id': 'E16059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video Decision Aid', 'description': 'This group will be shown a video decision aid along with their standard of care.', 'interventionNames': ['Other: Video Decision Aid']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'This group will not see the video decision aid and will only receive standard of care.'}], 'interventions': [{'name': 'Video Decision Aid', 'type': 'OTHER', 'otherNames': ['VDA'], 'description': 'A video decision aid was developed inform patients about pelvic organ prolapse, to include female anatomy, and treatment options.', 'armGroupLabels': ['Video Decision Aid']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Teodoro I Montoya, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University Health Sciences Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University Health Sciences Center, El Paso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Teodoro Ignacio Montoya', 'investigatorAffiliation': 'Texas Tech University Health Sciences Center, El Paso'}}}}