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Video Decision Aid in Latina Women With Pelvic Organ Prolapse

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video Decision Aid
Sponsored by
Texas Tech University Health Sciences Center, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pelvic Organ Prolapse focused on measuring Decision Aid, Pelvic Organ Prolapse (POP)

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Video Decision Aid

    Standard Care

    Arm Description

    This group will be shown a video decision aid along with their standard of care.

    This group will not see the video decision aid and will only receive standard of care.

    Outcomes

    Primary Outcome Measures

    Change from baseline decisional conflict score at 6 months.
    Decisional Conflict Scale will be used

    Secondary Outcome Measures

    Change from baseline knowledge of condition score at 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.
    Satisfaction with Decision Scale-(PFD) will be used

    Full Information

    First Posted
    July 7, 2016
    Last Updated
    April 24, 2019
    Sponsor
    Texas Tech University Health Sciences Center, El Paso
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02850835
    Brief Title
    Video Decision Aid in Latina Women With Pelvic Organ Prolapse
    Official Title
    Role of Video Decision Aid in Pelvic Organ Prolapse Treatment Selection in Latina Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    August 17, 2017 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Texas Tech University Health Sciences Center, El Paso

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Organ Prolapse
    Keywords
    Decision Aid, Pelvic Organ Prolapse (POP)

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Video Decision Aid
    Arm Type
    Experimental
    Arm Description
    This group will be shown a video decision aid along with their standard of care.
    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    This group will not see the video decision aid and will only receive standard of care.
    Intervention Type
    Other
    Intervention Name(s)
    Video Decision Aid
    Other Intervention Name(s)
    VDA
    Intervention Description
    A video decision aid was developed inform patients about pelvic organ prolapse, to include female anatomy, and treatment options.
    Primary Outcome Measure Information:
    Title
    Change from baseline decisional conflict score at 6 months.
    Description
    Decisional Conflict Scale will be used
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change from baseline knowledge of condition score at 6 months.
    Description
    12-item questionnaire of female pelvic anatomy and pelvic organ prolapse concepts will be used
    Time Frame
    6 months
    Title
    Change from baseline satisfaction with selected treatment at 6 months.
    Description
    Satisfaction with Decision Scale-(PFD) will be used
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Teodoro I Montoya, M.D.
    Organizational Affiliation
    Texas Tech University Health Sciences Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19935030
    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.
    Results Reference
    background
    PubMed Identifier
    17138771
    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.
    Results Reference
    background
    PubMed Identifier
    12066091
    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.
    Results Reference
    background
    PubMed Identifier
    16647928
    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.
    Results Reference
    background
    PubMed Identifier
    7240708
    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.
    Results Reference
    background
    PubMed Identifier
    23597598
    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.
    Results Reference
    background
    PubMed Identifier
    10487995
    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.
    Results Reference
    background
    PubMed Identifier
    31008776
    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.
    Results Reference
    derived

    Learn more about this trial

    Video Decision Aid in Latina Women With Pelvic Organ Prolapse

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