A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas

NCT06679621 | Recruiting DMC

• 2 other identifiers: 3000121041K23HD115269
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

Brief Summary

There are 3 aims of this study. In Aim 1 community patient partners will be enrolled to help guide the research being performed in all of the aims. Investigators will also administer a survey that will help determine factors associated with surgical preparedness. In Aim 2 investigators will develop an intervention to increase surgical preparedness using Human Centered Design Methods. Aim 3 will pilot test the intervention using mixed methods to determine feasibility and implementation outcomes.

Conditions

Incontinence; Prolapse

Outcome Measures

Primary Outcomes (3)

• Feasibility of the Intervention

  A feasible study will be defined a 1) \>4 on 1-5 Likert-type scales of acceptability, appropriateness, and feasibility; 2) \>70% for adherence; and 3)\> 90% for dose delivery, and percent completed intervention. Acceptability will be measured by the Acceptability of the Intervention Measure Appropriateness will be measured by the Intervention Appropriateness Measure Feasibility will be measured by the Feasibility of Intervention Measure

  Day of Surgery, before surgery, in the preoperative holding

• Acceptability of the Intervention

  As measured by the Acceptability of the Intervention Measure

  Day of Surgery, before surgery, in the preoperative holding

• Appropriateness of the Intervention

  As measured by the Intervention Appropriateness Measure

  Day of Surgery, before surgery, in the preoperative holding

Secondary Outcomes (7)

• Surgical Preparedness

  Day of Surgery, before surgery, in the preoperative holding

• Health Literacy

  Preoperative Visit, before surgery

• Self-Efficacy

  Preoperative Visit, before surgery

• Trust in Provider

  Preoperative Visit, before surgery

• Decisional Conflict

  Day of Surgery, before surgery, in the preoperative holding

Other Outcomes (7)

• Demographics

  Preoperative Visit 6-8 weeks after surgery

• Surgical Data

  Day of Surgery, before surgery, in the preoperative holding

• Adverse Events

  Postoperative Visit 6-8 weeks after surgery

Study Arms (2)

Routine Preoperative Counseling

NO INTERVENTION

Participants scheduled to undergo urogynecologic surgery will receive routine preoperative counseling.

Telehealth intervention

EXPERIMENTAL

Patient scheduled to undergo urogynecologic surgery will receive routine preoperative counseling in addition to the modified telehealth intervention.

Behavioral: Telehealth intervention

Interventions

Telehealth intervention BEHAVIORAL

This telehealth intervention will be made using human centered design methods

Telehealth intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who
• Self-report as female
• years and older
• Self-report as Hispanic ethnicity
• 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)
• Able to read and write English and/or Spanish
• Urogynecologists who -Routinely perform urogynecologist surgeries to correct pelvic organ prolapse, urinary/fecal incontinence, fistula, urethral masses
• Nurses who
• Spend most of their time at a urogynecologic clinic
• Engage in the process of preparing patients for urogynecologic surgery

You may not qualify if:

• Patients who
• Self-report as male
• Are less than 18 years of age
• Self-report as not of Hispanic ethnicity
• Scheduled to undergo a surgery for a condition that is not urogynecologic or is not in the operating room
• Patients undergoing procedures that are traditionally performed in the office (bladder Botox, pelvic floor Botox, urethral bulking)
• Urogynecologists who
• Do not routinely perform urogynecologic surgery
• Nurses who
• Do not spend most of their time at a urogynecology clinic
• Do not engage in the process of preparing patients for urogynecologic surgery

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Alabama Birmginham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriela Halder, MD, MPH

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela Halder, MD, MPH

CONTACT

205-934-5498; gehalder@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The randomized design is for Aim 3 of our study.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)