Actively Recruiting
A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas
Led by University of Alabama at Birmingham · Updated on 2025-07-24
357
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying surgical preparedness in Latinas undergoing urogynecologic surgery to develop and test a telehealth intervention called TIPPS-Latina. The study aims to understand factors affecting preparedness, design a patient-centered intervention using Human Centered Design and Dissemination & Implementation methods, and pilot test the intervention for feasibility and implementation. This project involves a participatory action framework guiding all study phases. Participants scheduled for urogynecologic surgery will be randomly assigned to receive either routine preoperative counseling alone or routine counseling plus the TIPPS-Latina telehealth intervention. The intervention development follows a three-phase Discover, Design/Build, and Test framework, using mixed methods to refine and evaluate the telehealth support tailored for Latinas. The study includes community patient partners to guide research and intervention design. Participants will complete assessments including the Surgical Preparedness Assessment, health literacy, self-efficacy, trust in provider, decisional conflict, anxiety/depression, and satisfaction with healthcare services. These are measured at preoperative visits, on the day of surgery before the procedure, and 6-8 weeks postoperatively. The study evaluates the intervention's feasibility, acceptability, and appropriateness during preoperative holding on surgery day, with monitoring of implementation outcomes and patient-reported measures over the course of the trial.
CONDITIONS
Brief Title
A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-report as female
- Age 18 years or older
- Self-report as Hispanic ethnicity
- Scheduled for urogynecologic surgery in an operating room (including surgery for pelvic organ prolapse, urinary/fecal incontinence, fistula, urethral masses)
- Able to read and write English and/or Spanish
- Urogynecologists who routinely perform urogynecologic surgeries
- Nurses who spend most time at a urogynecologic clinic and prepare patients for surgery
You will not qualify if you...
- Self-report as male
- Under 18 years of age
- Not of Hispanic ethnicity
- Scheduled for surgery not urogynecologic or not in an operating room
- Undergoing procedures usually done in office (bladder Botox, pelvic floor Botox, urethral bulking)
- Urogynecologists who do not routinely perform urogynecologic surgery
- Nurses who do not spend most time at a urogynecologic clinic or do not prepare patients for surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the day of surgery
Participants scheduled for urogynecologic surgery receive routine preoperative counseling, with some also receiving a telehealth intervention designed to increase surgical preparedness.
1 preoperative visit and 1 day of surgery visit (in-person)
Duration - 6 to 8 weeks after surgery
Participants have a postoperative visit to assess satisfaction with healthcare services and recovery after surgery.
1 postoperative visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Alabama Birmginham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
G
Gabriela Halder, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here