IncontinenceTIPPS-UrogynNCT06679621
A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas
A study testing Telehealth intervention in people with Incontinence and Prolapse, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incontinence, Prolapse
- What is being tested?
- Telehealth intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama Birmginham
Birmingham, Alabama, 35294
Gabriela Principal Investigator, 205-934-5498, gehalder@uabmc.edu
About this study
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.
Read the detailed description
The purpose of this project is to understand surgical preparedness in Latinas undergoing urogynecologic surgery and to develop TIPPS-Latina a refined version of our telehealth intervention for Latinas undergoing urogynecologic surgery using HCD and D\&I methods. The goal of the first aim is to develop a participatory design approach and understand surgical preparedness in Latinas undergoing urogynecologic surgery. This cross-sectional study will run in parallel to the other aims. The participatory action framework will guide Aims 1-3. The goals of Aim 2 and Aim 3 are develop and test TIPPS-Latina using the Discover, Design/Build, and Test (DDBT) framework, which is a HCD method to generate evidence-based interventions and their implementations9. During the Discover phase investigators will identify preferences for refinement of TIPPS-Latina and its contextual deployment using mixed methods. During the Design/Build phase investigators will use an iterative process to generate, modify, and adapt our intervention. During the Test phase investigators will conduct pilot testing of TIPPS-Latina using a mixed methods approach that determines feasibility and implementation outcomes. Throughout our study, surgical preparedness will be measured using the Surgical Preparedness Assessment (SPA), a validated survey for measuring preparedness in women undergoing urogynecologic surgery that was developed by our group
- Conditions
- Incontinence, Prolapse
- Being tested
- Telehealth intervention
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth interventionBehavioural
This telehealth intervention will be made using human centered design methods
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telehealth intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day of Surgery, before surgery, in the preoperative holding
Acceptability of the Intervention
As measured by the Acceptability of the Intervention Measure
Measured: Day of Surgery, before surgery, in the preoperative holding
Appropriateness of the Intervention
As measured by the Intervention Appropriateness Measure
Measured: Day of Surgery, before surgery, in the preoperative holding
Secondary outcomes (7)
Surgical Preparedness
As measured by the Surgical Preparedness Assessment survey
Measured: Day of Surgery, before surgery, in the preoperative holding
Health Literacy
As measured by the Brief Health Literacy Screen
Measured: Preoperative Visit, before surgery
Self-Efficacy
As measured by the General Self-Efficacy Scale
Measured: Preoperative Visit, before surgery
Trust in Provider
As measured by the Trust in Provider Scale
Measured: Preoperative Visit, before surgery
Decisional Conflict
As measured by the Decisional Conflict Scale
Measured: Day of Surgery, before surgery, in the preoperative holding
Postoperative Anxiety/Depression
As measured by the Hospital Anxiety/Depression Scale
Measured: Preoperative Visit, before surgery
Satisfaction with Healthcare Services
As measured by the CAHPS Clinician \& Group Visit Adult Survey
Measured: Postoperative Visit 6-8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Nov 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IncontinenceStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized design is for Aim 3 of our study.
- Masking
- None (open label)
- Enrolment
- 357 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Gabriela Halder, University of Alabama at Birmingham
- Investigators
- Gabriela Halder, MD, MPH, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679621
- Sponsor's protocol ID
- 300012104
- Other IDs
- 1K23HD115269
- Acronym
- TIPPS-Urogyn
- Status last verified
- Aug 2026
- First submitted
- 5 Nov 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas
- ClinicalTrials.gov ID
- NCT06679621
- Acronym / sponsor ID
- TIPPS-Urogyn / 300012104
- Conditions
- Incontinence, Prolapse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 357 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this project is to understand surgical preparedness in Latinas undergoing urogynecologic surgery and to develop TIPPS-Latina a refined version of our telehealth intervention for Latinas undergoing urogynecologic surgery using HCD and D\&I methods. The goal of the first aim is to develop a participatory design approach and understand surgical preparedness in Latinas undergoing urogynecologic surgery. This cross-sectional study will run in parallel to the other aims. The participatory action framework will guide Aims 1-3. The goals of Aim 2 and Aim 3 are develop and test TIPPS-Latina using the Discover, Design/Build, and Test (DDBT) framework, which is a HCD method to generate evidence-based interventions and their implementations9. During the Discover phase investigators will identify preferences for refinement of TIPPS-Latina and its contextual deployment using mixed methods. During the Design/Build phase investigators will use an iterative process to generate, modify, and adapt our intervention. During the Test phase investigators will conduct pilot testing of TIPPS-Latina using a mixed methods approach that determines feasibility and implementation outcomes. Throughout our study, surgical preparedness will be measured using the Surgical Preparedness Assessment (SPA), a validated survey for measuring preparedness in women undergoing urogynecologic surgery that was developed by our group
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomized design is for Aim 3 of our study.
| Arm | Type | Receives |
|---|---|---|
| Routine Preoperative Counseling | No intervention | –Participants scheduled to undergo urogynecologic surgery will receive routine preoperative counseling. |
| Telehealth intervention | Experimental | Behavioral: Telehealth interventionPatient scheduled to undergo urogynecologic surgery will receive routine preoperative counseling in addition to the modified telehealth intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth interventionThis telehealth intervention will be made using human centered design methods | Behavioural | Telehealth intervention |
Primary outcome
Feasibility of the Intervention
Time frame: Day of Surgery, before surgery, in the preoperative holding
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
Acceptability of the Intervention
Time frame: Day of Surgery, before surgery, in the preoperative holding
As measured by the Acceptability of the Intervention Measure
Appropriateness of the Intervention
Time frame: Day of Surgery, before surgery, in the preoperative holding
As measured by the Intervention Appropriateness Measure
7 secondary outcomes
Surgical Preparedness
Time frame: Day of Surgery, before surgery, in the preoperative holding
Health Literacy
Time frame: Preoperative Visit, before surgery
Self-Efficacy
Time frame: Preoperative Visit, before surgery
Trust in Provider
Time frame: Preoperative Visit, before surgery
Decisional Conflict
Time frame: Day of Surgery, before surgery, in the preoperative holding
Postoperative Anxiety/Depression
Time frame: Preoperative Visit, before surgery
Satisfaction with Healthcare Services
Time frame: Postoperative Visit 6-8 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriela Halder, MD, MPH principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth intervention in people with Incontinence and Prolapse, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Halder, MD, MPH (205-934-5498, gehalder@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention (time frame: Day of Surgery, before surgery, in the preoperative holding). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.