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Audiovisual Decision Aid for Urinary Incontinence (ECAPS Trial)

N/A
Waitlist Available
Led By Marian G Acevedo-Alvarez, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients electing for surgical intervention of pelvic organ prolapse, stress urinary incontinence, urgency urinary incontinence by treating physicians in the Female Pelvic Medicine & Reconstructive Surgery.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0
Awards & highlights

ECAPS Trial Summary

This trial will test whether an AVDA can help patients understand their surgical consent better than the traditional verbal method, and whether it has a bigger impact on patients with lower levels of health literacy.

Who is the study for?
This trial is for English-speaking adults choosing surgery for pelvic organ prolapse or urinary incontinence. It's not for those under 18, non-English speakers, or individuals with audiovisual impairments that prevent them from using the decision aid.Check my eligibility
What is being tested?
The study is testing an easy-to-understand audiovisual decision aid (AVDA) designed to help patients give informed consent for surgery. This AVDA will be compared to the usual verbal consent process.See study design
What are the potential side effects?
Since this trial involves an informational tool rather than a medical treatment, there are no direct physical side effects. However, participants may experience different levels of understanding or satisfaction.

ECAPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am choosing surgery for pelvic organ prolapse or urinary incontinence.

ECAPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Preparedness for surgery

ECAPS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Will view audiovisual decision aid (AVDA) and then have opportunity for questions with physician before signing consent forms
Group II: Control GroupActive Control1 Intervention
Will undergo standard verbal informed consent with physician before signing consent forms

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,776 Total Patients Enrolled
Marian G Acevedo-Alvarez, MDPrincipal InvestigatorLoyola Medical Center

Media Library

audiovisual decision aid Clinical Trial Eligibility Overview. Trial Name: NCT03988569 — N/A
Stress Incontinence Research Study Groups: Intervention Group, Control Group
Stress Incontinence Clinical Trial 2023: audiovisual decision aid Highlights & Side Effects. Trial Name: NCT03988569 — N/A
audiovisual decision aid 2023 Treatment Timeline for Medical Study. Trial Name: NCT03988569 — N/A

Frequently Asked Questions

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

How many participants are being recruited for this experiment?

"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial is accepting participants, commencing from July 1st 2019 and most recently revised on March 17th 2022. The research requires 158 people to be recruited for a single location."

Answered by AI

Is recruitment currently active for this research endeavor?

"Confirmed by clinicaltrials.gov, this study is actively recruiting participants with the first post date of July 1st 2019 and last update recorded on March 17th 2022."

Answered by AI
Recent research and studies
Journal of Health Care for the Poor and UnderservedJournal
Illiteracy Among Medicaid Recipients and Its Relationship to Health Care Costs
Weiss, Barry D., Jay S. Blanchard, Daniel L. McGee, Gregory Hart, Barbara Warren, Michael Burgoon, and Kenneth J. Smith. 1994. “Illiteracy Among Medicaid Recipients and Its Relationship to Health Care Costs”. Journal of Health Care for the Poor and Underserved. Project Muse. doi:10.1353/hpu.2010.0272.
Journal of Medical EthicsJournal
Recent Insights into Decision-making and Their Implications for Informed Consent
Vos, Irene M L, Maartje H N Schermer, and Ineke L L E Bolt. 2018. “Recent Insights into Decision-making and Their Implications for Informed Consent”. Journal of Medical Ethics. BMJ. doi:10.1136/medethics-2018-104884.
Patient Education and CounselingJournal
Development of a Brief Test to Measure Functional Health Literacy
Baker, David W, Mark V Williams, Ruth M Parker, Julie A Gazmararian, and Joanne Nurss. 1999. “Development of a Brief Test to Measure Functional Health Literacy”. Patient Education and Counseling. Elsevier BV. doi:10.1016/s0738-3991(98)00116-5.
Health LiteracyJournal
Committee on Health Literacy, Board on Neuroscience and Behavioral Health, and Institute of Medicine. <i>Health Literacy</i>. Ed. Lynn Nielsen-Bohlman, Allison M. Panzer, and David A. Kindig. National Academies Press, 2004. <i>Crossref</i>. Web. <https://doi.org/10.17226/10883>..
Committee on Health Literacy, Board on Neuroscience and Behavioral Health, and Institute of Medicine. 2004. Health Literacy. Edited by Lynn Nielsen-Bohlman, Allison M. Panzer, and David A. Kindig. []. National Academies Press. doi:10.17226/10883.
~27 spots leftby Apr 2025
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