Improving Care for Women With Urinary Incontinence (EMPOWER)
NCT ID: NCT05515198
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2022-09-06
2024-12-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Patient Education
Patient Education
Patients will be provided educational opportunities.
Arm 2
Patient Education + Nurse Navigation
Patient Education
Patients will be provided educational opportunities.
Nurse Navigation
A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
Arm 3
Patient Education + Nurse Navigation + ChatBot
Patient Education
Patients will be provided educational opportunities.
Nurse Navigation
A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
ChatBot
A ChatBot will allow participants to directly and privately communicate through a smartphone (or other device) with an artificial intelligence-driven ChatBot, also known as a "conversational agent," that will provide education and encouragement to manage their symptoms.
Interventions
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Patient Education
Patients will be provided educational opportunities.
Nurse Navigation
A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
ChatBot
A ChatBot will allow participants to directly and privately communicate through a smartphone (or other device) with an artificial intelligence-driven ChatBot, also known as a "conversational agent," that will provide education and encouragement to manage their symptoms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ≥ 18 years old
3. Scores 1 or higher on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Adonis Hijaz, MD
Vice Chair of Academics and Research for the Urology Institute
Principal Investigators
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Adonis Hijaz, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Goutham Rao, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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20211420
Identifier Type: -
Identifier Source: org_study_id
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