Improving Care for Women With Urinary Incontinence (EMPOWER)
Primary Purpose
Urinary Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Education
Nurse Navigation
ChatBot
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring women, female, urinary incontinence, empowering, EMPOWER, providers, bladder leakage, incontinence
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:
None
Sites / Locations
- University Hospitals Cleveland Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Patient Education
Patient Education + Nurse Navigation
Patient Education + Nurse Navigation + ChatBot
Outcomes
Primary Outcome Measures
Change in patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
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.
Patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
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.
Patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
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 Outcome Measures
Change in patients' perceived self-efficacy for UI communication as measured by the PEPPI
Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient-Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI. The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.
Patients' perceived self-efficacy for UI communication as measured by the PEPPI
Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient- Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI. The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.
Patients' perceived self-efficacy for UI communication as measured by the PEPPI
Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient- Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI. The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.
Change in patient empowerment as measured by a patient survey
Patient empowerment will be measured by a patient survey to measure with percentage of patients answering yes to speaking with their provider about UI.
Change in overactive bladder symptom severity as measured by the OABSS
Patients' overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS). The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.
Overactive bladder symptom severity as measured by the OABSS
Patients' overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS). The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.
Overactive bladder symptom severity as measured by the OABSS
Overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS). The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.
Change in urinary symptoms as measured by the UDI-6
How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6). The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.
Urinary symptoms as measured by the UDI-6
How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6). The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.
Urinary symptoms as measured by the UDI-6
How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6). The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.
Change in impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol
The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.
Impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol
The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.
Impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol
The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.
Change in patients' perceived symptom improvement as measured by the PGI-I
Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I). PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse."
Patients' perceived symptom improvement as measured by the PGI-I
Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I). PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse."
Patients' perceived symptom improvement as measured by the PGI-I
Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I). PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse."
Number of practices that maintain a UI management intervention as measured by the practice survey
Maintenance of UI management intervention will be assessed by practice survey with indication of continuation for each intervention component.
Number of practices that implement a UI point person as measured by the practice survey
Implementation of a UI point person will be measured as a percentage of sites answer yes on practice survey.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05515198
Brief Title
Improving Care for Women With Urinary Incontinence (EMPOWER)
Official Title
Empowering Women and Providers for Improved Care of Urinary Incontinence (UI) [EMPOWER Study]
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adonis Hijaz, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
women, female, urinary incontinence, empowering, EMPOWER, providers, bladder leakage, incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Patient Education
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Patient Education + Nurse Navigation
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Patient Education + Nurse Navigation + ChatBot
Intervention Type
Other
Intervention Name(s)
Patient Education
Other Intervention Name(s)
Education
Intervention Description
Patients will be provided educational opportunities.
Intervention Type
Other
Intervention Name(s)
Nurse Navigation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ChatBot
Other Intervention Name(s)
Behavioral/exercise via chatbot
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Description
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.
Time Frame
Baseline and Months 2 and 6 (all Waves)
Title
Patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Description
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.
Time Frame
12 months (Waves 1 and 2)
Title
Patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Description
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.
Time Frame
18 months (Wave 1)
Secondary Outcome Measure Information:
Title
Change in patients' perceived self-efficacy for UI communication as measured by the PEPPI
Description
Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient-Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI. The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.
Time Frame
Baseline and Months 2 and 6 (all Waves)
Title
Patients' perceived self-efficacy for UI communication as measured by the PEPPI
Description
Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient- Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI. The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.
Time Frame
12 months (Waves 1 and 2)
Title
Patients' perceived self-efficacy for UI communication as measured by the PEPPI
Description
Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient- Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI. The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.
Time Frame
18 months (Wave 1)
Title
Change in patient empowerment as measured by a patient survey
Description
Patient empowerment will be measured by a patient survey to measure with percentage of patients answering yes to speaking with their provider about UI.
Time Frame
Baseline and Months 2 and 6 (all Waves)
Title
Change in overactive bladder symptom severity as measured by the OABSS
Description
Patients' overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS). The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.
Time Frame
Baseline and Months 2 and 6 (all Waves)
Title
Overactive bladder symptom severity as measured by the OABSS
Description
Patients' overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS). The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.
Time Frame
12 months (Waves 1 and 2)
Title
Overactive bladder symptom severity as measured by the OABSS
Description
Overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS). The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.
Time Frame
18 months (Wave 1)
Title
Change in urinary symptoms as measured by the UDI-6
Description
How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6). The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.
Time Frame
Baseline and Months 2 and 6 (all Waves)
Title
Urinary symptoms as measured by the UDI-6
Description
How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6). The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.
Time Frame
12 months (Waves 1 and 2)
Title
Urinary symptoms as measured by the UDI-6
Description
How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6). The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.
Time Frame
18 months (Wave 1)
Title
Change in impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol
Description
The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.
Time Frame
Baseline and Months 2 and 6 (all Waves)
Title
Impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol
Description
The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.
Time Frame
12 months (Waves 1 and 2)
Title
Impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol
Description
The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.
Time Frame
18 months (Wave 1)
Title
Change in patients' perceived symptom improvement as measured by the PGI-I
Description
Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I). PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse."
Time Frame
Months 2 and 6 (all Waves)
Title
Patients' perceived symptom improvement as measured by the PGI-I
Description
Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I). PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse."
Time Frame
12 months (Waves 1 and 2)
Title
Patients' perceived symptom improvement as measured by the PGI-I
Description
Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I). PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse."
Time Frame
18 months (Wave 1)
Title
Number of practices that maintain a UI management intervention as measured by the practice survey
Description
Maintenance of UI management intervention will be assessed by practice survey with indication of continuation for each intervention component.
Time Frame
1 month post completion of each Wave's enrollment period
Title
Number of practices that implement a UI point person as measured by the practice survey
Description
Implementation of a UI point person will be measured as a percentage of sites answer yes on practice survey.
Time Frame
1 month post completion of each Wave's enrollment period
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females only
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Divoky
Phone
(216) 844-8092
Email
Ellen.Divoky@UHhospitals.org
First Name & Middle Initial & Last Name or Official Title & Degree
Elisar Khawam
Phone
(216) 844-2493
Email
Elisar.Khawam@UHhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adonis Hijaz, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Goutham Rao, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisar Khawam
Phone
216-844-2493
Email
elisar.khawam@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Ellen Divoky
Phone
216-844-8092
Email
ellen.divoky@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Adonis Hijaz, MD
First Name & Middle Initial & Last Name & Degree
Goutham Rao, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial will be made available after de-identification.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal may use the data for any purpose.
Learn more about this trial
Improving Care for Women With Urinary Incontinence (EMPOWER)
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