Race, Ethnicity, Socioeconomic Status and Prolapse-rElated Decisional ConflicT
NCT ID: NCT04977141
Last Updated: 2025-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
210 participants
OBSERVATIONAL
2021-07-07
2024-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of a Decision Aid on Decision Making for the Treatment of Pelvic Organ Prolapse
NCT01798082
Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse
NCT00714155
Quality of Life After Conservative and Surgical Treatment of Pelvic Organ Prolapse
NCT04110821
Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
NCT00099372
Pelvic Floor Disorder Assessment of Knowledge and Symptoms: an Educational Model in Spanish-Speaking Women
NCT04829721
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After the new-patient consultation, patients will be contacted to see if they are interested in the study. If so, informed consent will be obtained before they complete a 1 page questionnaire that assesses their eligibility for participation.
The questionnaires are: Decisional Conflict Scale; Pelvic Floor Disorders Autonomy Preference Index; Control Preferences Scale; Pelvic Floor Distress Inventory (PFDI 20); Satisfaction with Decision Scale for Pelvic Floor Disorders; Impression questionnaire.
Patients will self-identify their zip-code on the patient impression questionnaire. This will enable a geographic analysis that will assess the relationships of neighborhood and commute on decision making.
For the purposes of this study, patients will self-identify their demographic information.
URM patients will be those who self-identify as having a non-Caucasian race and/or a Hispanic ethnicity. Providers seeing patients that are included in this study will also be consented prior to completing a 1 time demographics questionnaire. Additional clinical data will also be obtained.
Patients will be able to utilize interpreters to participate. Information regarding the use of interpreters will be collected. Questionnaires that are available in, and validated in, non-English languages will be used as appropriate.
The lead study site is Women \& Infants Hospital/ Brown University, with additional study sites planning to participate in the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Under-represented minority
Non-English speaking and/or non-White
Decisional Conflict Scale
Decisional Conflict Scale
Non-under-represented minority
English-speaking and/or White
Decisional Conflict Scale
Decisional Conflict Scale
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Decisional Conflict Scale
Decisional Conflict Scale
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Provider inclusion criteria consists of FPMRS providers at study sites seeing new patients with symptoms of pelvic organ prolapse. Patient inclusion criteria consists of new patients 18 years or older with symptoms of pelvic organ prolapse.
Exclusion Criteria:
* Provider exclusion criteria consists of providers who decline participation. Patient exclusion criteria consists of patients who decline participation, and those who cannot complete the study interventions with the assistance of an interpreter.
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fellows Pelvic Research Network (sponsor)
UNKNOWN
Northwestern University
OTHER
University of New Mexico
OTHER
University of California, Irvine
OTHER
University of South Florida
OTHER
Emory University
OTHER
University of Alabama at Birmingham
OTHER
Johns Hopkins University
OTHER
Women and Infants Hospital of Rhode Island
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Julia Shinnick
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julia K Shinnick, MD
Role: PRINCIPAL_INVESTIGATOR
Women & Infants Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Women & Infants Hospital
Providence, Rhode Island, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1674479
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.