Recruiting

Telehealth Intervention

Sponsor:

University of Alabama at Birmingham

Code:

NCT06679621

Conditions

Incontinence

Prolapse

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Telehealth intervention

Study Details

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

Study ID

NCT06679621

Start date

Nov 1, 2024

Status verified date

Aug, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Patients who

  • Self-report as female
  • 18 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

Exclusion Criteria:

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

Study Design

Enrollment

357 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Routine Preoperative Counseling

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

experimental: Telehealth intervention

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

Interventions

Telehealth intervention

This telehealth intervention will be made using human centered design methods

Primary outcome measure

  • Feasibility of the Intervention [ Time Frame: Day of Surgery, before surgery, in the preoperative holding ]
  • Acceptability of the Intervention [ Time Frame: Day of Surgery, before surgery, in the preoperative holding ]
  • Appropriateness of the Intervention [ Time Frame: Day of Surgery, before surgery, in the preoperative holding ]

Central Contacts and Locations

Central contacts

Gabriela Halder, MD, MPH

205-934-5498gehalder@uabmc.edu

Locations

University of Alabama Birmginham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Gabriela Principal Investigator

205-934-5498gehalder@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-14.