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Clinical Trials/NCT05515198
NCT05515198
Completed
Not Applicable

Empowering Women and Providers for Improved Care of Urinary Incontinence (UI) [EMPOWER Study]

University Hospitals Cleveland Medical Center1 site in 1 country400 target enrollmentSeptember 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
University Hospitals Cleveland Medical Center
Enrollment
400
Locations
1
Primary Endpoint
Patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The overall goal is to improve diagnosis and non-operative management of urinary incontinence in women.

Detailed Description

In the study, patients will be screened in primary care offices for symptoms of urinary incontinence. Women with positive screening results will be asked if they are interested in participating in an implementation study where women will be assigned to one of the three following groups: 1. Usual Care plus Patient Educational Opportunities - The patient's urinary incontinence will be managed using standard of care treatment by the patient's primary care provider. Patients will be offered educational opportunities about urinary incontinence. 2. Nurse Navigation - Along with the treatment described for "Usual Care plus Patient Educational Opportunities," a nurse navigator will work with the patient to implement behavioral changes and provide education and physical therapy options. In addition, the navigator will be available to answer the patient's questions in a timely fashion and help the patient move through the care pathway. 3. Nurse Navigation and ChatBot - Along with the treatment described for "Usual Care plus Patient Educational Opportunities" and "Nurse Navigation," this group will include a ChatBot feature which will allow a patient to directly and privately communicate with an artificial intelligence-driven ChatBot, also known as a "conversational agent," that will provide education and help the patient navigate the care pathway. All participants will complete questionnaires throughout their enrollment and data will be collected from medical records. The study team will analyze the data at six months after the original appointment/study enrollment, assess adherence to therapy and how the therapy impacted the outcomes the team hopes to improve, such as improvement in symptoms. The study will be implemented over three subsequent time periods called Wave 1, Wave 2 and Wave 3 with primary care practices from two geographic regions being involved in each wave (6 regions total). Participants in Wave 1 will be followed for a total of 18 months, while participants in Wave 2 will be followed for a total of 12 months, and participants in Wave 3 will be followed for 6 months. Primary care providers at all participating practices will be offered educational opportunities related to urinary incontinence.

Registry
clinicaltrials.gov
Start Date
September 6, 2022
End Date
December 23, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adonis Hijaz, MD

Vice Chair of Academics and Research for the Urology Institute

University Hospitals Cleveland Medical Center

Eligibility Criteria

Inclusion Criteria

  • Female patient having a primary care provider visit at University Hospitals (UH) Cleveland Primary Care Institute (PCI)
  • ≥ 18 years old
  • Scores 1 or higher on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

Time Frame: 18 months (Wave 1)

The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.

Change in patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

Time Frame: Baseline and Months 2 and 6 (all Waves)

The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.

Secondary Outcomes

  • Impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol(18 months (Wave 1))
  • Number of practices that implement a UI point person as measured by the practice survey(1 month post completion of each Wave's enrollment period)
  • Urinary symptoms as measured by the UDI-6(18 months (Wave 1))
  • Patients' perceived self-efficacy for UI communication as measured by the PEPPI(18 months (Wave 1))
  • Change in patient empowerment as measured by a patient survey(Baseline and Months 2 and 6 (all Waves))
  • Change in overactive bladder symptom severity as measured by the OABSS(Baseline and Months 2 and 6 (all Waves))
  • Change in urinary symptoms as measured by the UDI-6(Baseline and Months 2 and 6 (all Waves))
  • Change in impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol(Baseline and Months 2 and 6 (all Waves))
  • Patients' perceived symptom improvement as measured by the PGI-I(18 months (Wave 1))
  • Change in patients' perceived self-efficacy for UI communication as measured by the PEPPI(Baseline and Months 2 and 6 (all Waves))
  • Overactive bladder symptom severity as measured by the OABSS(18 months (Wave 1))
  • Change in patients' perceived symptom improvement as measured by the PGI-I(Months 2 and 6 (all Waves))
  • Number of practices that maintain a UI management intervention as measured by the practice survey(1 month post completion of each Wave's enrollment period)

Study Sites (1)

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