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Telehealth Intervention for Surgical Preparedness (TIPPS-Latina Trial)

N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients scheduled to undergo a surgery for a urogynecologic condition in the operating room (surgery to correct pelvic organ prolapse, urinary/fecal incontinence, fistula, urethral masses)
Patients who self-report as female
Must not have
Patients who are less than 18 years of age
Patients who self-report as male
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative visit, before surgery and postoperative visit 6-8 weeks after surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to involve community patient partners to guide the research, identify factors related to surgical preparedness, develop an intervention to improve preparedness, and test the intervention to see if it is feasible and

Who is the study for?
This trial is for Latinas dealing with uterovaginal prolapse or bladder control issues. It aims to help them prepare for surgery using a telehealth intervention. Participants will be involved in guiding the research and providing feedback on the intervention's development.
What is being tested?
The study tests a new telehealth program designed to get patients ready for surgery related to prolapse conditions. The program's effectiveness will be evaluated through surveys, design methods, and pilot testing with community input.
What are the potential side effects?
Since this trial involves a non-invasive telehealth intervention rather than medication or surgical procedures, traditional physical side effects are not expected. However, participants may experience stress or discomfort from discussing medical conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery to address a pelvic condition.
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I identify as female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 years old.
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I identify as male.
Select...
I am scheduled for a surgery that is not related to urogynecology and not in the operating room.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery, before surgery, in the preoperative holding
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery, before surgery, in the preoperative holding for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability
Appropriateness
Feasibility
Secondary study objectives
Decisional Conflict
Health Literacy
Postoperative Anxiety/Depression
+4 more
Other study objectives
Adverse Events
Demographics
General Health
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Telehealth interventionExperimental Treatment1 Intervention
Patient scheduled to undergo urogynecologic surgery will receive routine preoperative counseling in addition to the modified telehealth intervention.
Group II: Routine Preoperative CounselingActive Control1 Intervention
Participants scheduled to undergo urogynecologic surgery will receive routine preoperative counseling.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,027 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,056 Previous Clinical Trials
2,737,787 Total Patients Enrolled
~238 spots leftby Nov 2027
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