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Decision Aid for Pelvic Organ Prolapse

N/A

Waitlist Available

Led By Hema Brazell

Research Sponsored by Hartford Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will help determine if a DA can reduce the amount of decisional conflict women face when choosing a plan of care for their prolapse.

Who is the study for?

This trial is for women over 18 years old who are scheduled for a consultation about pelvic organ prolapse and can communicate in English. It's not suitable for patients planning other non-gynecologic procedures, current patients of the practice, or those unwilling to participate.Check my eligibility

What is being tested?

The study is testing if a decision aid helps reduce uncertainty when women with pelvic organ prolapse decide on their treatment. Half will receive standard counseling plus the decision aid, while the other half will get only standard counseling.See study design

What are the potential side effects?

Since this trial involves a decision-making tool rather than medication or surgery, there aren't direct physical side effects. However, participants may experience emotional or psychological impacts from discussing their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in decisional conflict

Secondary outcome measures

Number of patients who choose surgery over conservative management

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard counseling, pelvic organ prolapse decision aidExperimental Treatment1 Intervention

In addition to standard counseling at the time of the initial new patient visit, the patients randomized to the experimental arm will recieve a pelvic organ prolapse decision aid prior to their initial visit.

Group II: Standard counselingActive Control1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor

133 Previous Clinical Trials

18,804 Total Patients Enrolled

Hema BrazellPrincipal InvestigatorHartford Hospital

Media Library

Pelvic organ prolapse decision aid Clinical Trial Eligibility Overview. Trial Name: NCT01798082 — N/A

Decisional Conflict Research Study Groups: Standard counseling, Standard counseling, pelvic organ prolapse decision aid

Decisional Conflict Clinical Trial 2023: Pelvic organ prolapse decision aid Highlights & Side Effects. Trial Name: NCT01798082 — N/A

Pelvic organ prolapse decision aid 2023 Treatment Timeline for Medical Study. Trial Name: NCT01798082 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the availability of participation in this clinical experiment?

"According to clinicaltrials.gov, the most recent update stemming from this trial was posted on August 27th 2013; thus it is not currently seeking applicants. Nevertheless, there are presently 1 other trials accepting candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of a Decision Aid on Decision Making for the Treatment of Pelvic Organ Prolapse

Hema Brazell 2012. "Effect of a Decision Aid on Decision Making for the Treatment of Pelvic Organ Prolapse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01798082.