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| ID | Type | Description | Link |
|---|---|---|---|
| 5U18HS028742-03 | U.S. AHRQ Grant/Contract | View source |
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The overall goal is to improve diagnosis and non-operative management of urinary incontinence in women.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patient Education |
|
| Arm 2 | Experimental | Patient Education + Nurse Navigation |
|
| Arm 3 | Experimental | Patient Education + Nurse Navigation + ChatBot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Education | Other | Patients will be provided educational opportunities. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each wave |
| 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. | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
None
Females only
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| Name | Affiliation | Role |
|---|---|---|
| Adonis Hijaz, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Goutham Rao, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
All of the individual participant data collected during the trial will be made available after de-identification.
Beginning 9 months and ending 36 months following publication.
Researchers who provide a methodologically sound proposal may use the data for any purpose.
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The study design is parallel cluster randomization (i.e., each cluster was randomized to an intervention or control) implemented at different times (i.e., waves). The stepped design was initially considered but we moved away after discussions with funders and need to update the study design section of CT.gov. The medical office was randomized and every eligible patient at the medical office who was interested in participating was recruited. The medical office was assigned the intervention.
Participants were recruited in UH primary care offices after completing a quality improvement initiative screening via the ICIQ-SF incontinence survey. Upon completion of the survey, if the patient scored a 1 or greater, they were invited to join the EMPOWER study. Recruitment timeline was, Wave 1: 6 months of intervention, then 18 months of follow-up, Wave 2: 6 months of intervention, then 12 months of follow-up, and Wave 3: 6 months of intervention, then 6 months of follow-up.
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Patient Education |
| FG001 | Arm 2 | Patient Education + Nurse Navigation |
| FG002 | Arm 3 | Patient Education + Nurse Navigation + ChatBot |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline analysis was completed for participants enrolled in each Arm, not practices. Each participant was assigned an Arm with the following interventions: Arm 1: Patient Education, Arm 2: Patient Education + Nurse Navigation, and Arm 3: Patient Education + Nurse Navigation + ChatBot. Participants were analyzed by Arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Patient Education |
| BG001 | Arm 2 | Patient Education + Nurse Navigation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each wave |
|
Adverse events were collected for enrolled participants over the study duration depending on which Wave they were recruited. Wave 1: AEs collected for 18 months Wave 2: AEs collected for 12 months Wave 3: AEs collected for 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Patient Education | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incarcerated umbilical hernia | Gastrointestinal disorders | Non-systematic Assessment | unexpected, significant, unrelated to the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoptysis | Gastrointestinal disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
Means and standard deviations are based on the observed/non-missing responses. Between arm contrasts are based on linear mixed effects models including all 400 participants randomized in the trial (the intention to treat population), with non-structurally missing responses addressed via multiple imputation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adonis Hijaz | UH Cleveland Medical Center | 216-844-3009 | Adonis.Hijaz@UHhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2023 | Dec 22, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 6, 2025 | Dec 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Nurse Navigation | Other | 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 | Other | 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. |
|
|
| 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18) |
| 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. | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave |
| 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. | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12) |
| 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. | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18) |
| Patient Empowerment as Measured by Number of Participants That Answered Yes to Speaking With Their Provider About UI. | Patient empowerment will be measured by a patient survey to measure with percentage of patients answering yes to speaking with their provider about UI. | Baseline (immediately prior to start of intervention) in all Waves |
| 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. | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave |
| 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. | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participant only last 6 months, not 12) |
| 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. | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 and 3 participants) |
| 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. | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave |
| 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. | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12) |
| 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. | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18) |
| 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. | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave |
| 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. | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12) |
| 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. | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18) |
| Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. | 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." Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point. For improvement it was calculated the number of participants who chose 1-3 only. | Months 2 and 6 post start of intervention in each Wave |
| Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. | 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." Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point. For improvement it was calculated the number of participants who chose 1-3 only. | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12) |
| Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. | 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." Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point. For improvement it was calculated the number of participants who chose 1-3 only. | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18) |
| 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 completed by participant at the practice with indication of continuation for each intervention component. | 1 month post completion of each Wave's enrollment period (7 months from beginning of screening period of each Wave) |
| 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. | 1 month post completion of each Wave's enrollment period (7 months from beginning of screening for each Wave) |
| BG002 |
| Arm 3 |
Patient Education + Nurse Navigation + ChatBot |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| BMI | Mean | Standard Deviation | kg/m^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. |
| OG002 | 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. |
|
|
| Primary | 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. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Mean | Standard Deviation | score on a scale | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12) |
|
|
|
|
| Secondary | 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. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Mean | Standard Deviation | score on a scale | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18) |
|
|
|
|
| Secondary | 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. | the means and standard deviations are based on the observed/non-missing responses, so n varies. | Posted | Mean | Standard Deviation | score on a scale | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave |
|
|
|
| Secondary | 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. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Mean | Standard Deviation | score on a scale | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12) |
|
|
|
| Secondary | 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. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Mean | Standard Deviation | score on a scale | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18) |
|
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|
| Secondary | Patient Empowerment as Measured by Number of Participants That Answered Yes to Speaking With Their Provider About UI. | Patient empowerment will be measured by a patient survey to measure with percentage of patients answering yes to speaking with their provider about UI. | Posted | Count of Participants | Participants | Baseline (immediately prior to start of intervention) in all Waves |
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|
| Secondary | 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. | Means and standard deviations are based on the observed/non-missing responses, so n varies. The missing responses were addressed via multiple imputation when estimating the between arm contrasts. | Posted | Mean | Standard Deviation | score on a scale | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave |
|
|
|
| Secondary | 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. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Mean | Standard Deviation | score on a scale | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participant only last 6 months, not 12) |
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|
| Secondary | 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. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Mean | Standard Deviation | score on a scale | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 and 3 participants) |
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| Secondary | 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. | Means and standard deviations are based on the observed/non-missing responses, so n varies. The missing responses were addressed via multiple imputation when estimating the between arm contrasts | Posted | Mean | Standard Deviation | score on a scale | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave |
|
|
|
| Secondary | 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. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Mean | Standard Deviation | score on a scale | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12) |
|
|
|
| Secondary | 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. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Mean | Standard Deviation | score on a scale | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18) |
|
|
|
| Secondary | 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. | Means and standard deviations are based on the observed/non-missing responses, so n varies. The missing responses were addressed via multiple imputation when estimating the between arm contrasts | Posted | Mean | Standard Deviation | score on a scale | Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave |
|
|
|
| Secondary | 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. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Mean | Standard Deviation | score on a scale | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12) |
|
|
|
| Secondary | 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. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Mean | Standard Deviation | score on a scale | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18) |
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| Secondary | Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. | 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." Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point. For improvement it was calculated the number of participants who chose 1-3 only. | Means and standard deviations are based on the observed/non-missing responses, so n varies. The missing responses were addressed via multiple imputation when estimating the between arm contrasts | Posted | Count of Participants | Participants | Months 2 and 6 post start of intervention in each Wave |
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| Secondary | Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. | 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." Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point. For improvement it was calculated the number of participants who chose 1-3 only. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Count of Participants | Participants | 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12) |
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| Secondary | Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. | 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." Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point. For improvement it was calculated the number of participants who chose 1-3 only. | 18-month follow-up data were only possible for Wave 1, and 12-month follow-up data were only available for Waves 1 and 2. As a result, some outcome data are structurally missing (i.e., not possible to observe) rather than missing due to attrition. To appropriately handle this, imputation procedures were conducted separately within each wave to respect the differing follow-up structures and avoid introducing bias. | Posted | Count of Participants | Participants | 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18) |
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| Secondary | 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 completed by participant at the practice with indication of continuation for each intervention component. | Only practices, and not participants, were analyzed for this Outcome Measure | Posted | Count of Units | Practices | 1 month post completion of each Wave's enrollment period (7 months from beginning of screening period of each Wave) | Practices | Practices |
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| Secondary | 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. | Only practices, and not participants, were analyzed for this Outcome Measure | Posted | Count of Units | Practices | 1 month post completion of each Wave's enrollment period (7 months from beginning of screening for each Wave) | Practices | Practices |
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| 158 |
| 2 |
| 158 |
| 11 |
| 158 |
| EG001 | Arm 2 | Patient Education + Nurse Navigation | 0 | 139 | 3 | 139 | 9 | 139 |
| EG002 | Arm 3 | Patient Education + Nurse Navigation + ChatBot | 0 | 103 | 5 | 103 | 9 | 103 |
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| gastric ulcers | Gastrointestinal disorders | Non-systematic Assessment | Non-bleeding gastric ulcers. Unexpected, unrelated to the study. |
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| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment | Unexpected, significant, unrelated to the study. |
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| Cerebrovascular accident (CVA) | Vascular disorders | Non-systematic Assessment | Unexpected, significant, unrelated to the study. |
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| Cholecystitis | Gastrointestinal disorders | Non-systematic Assessment | Unexpected, significant, unrelated to the study. |
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| Chest pain | Cardiac disorders | Non-systematic Assessment | Unexpected, significant, unrelated to the study. |
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| Pyelonephritis of right kidney | Renal and urinary disorders | Non-systematic Assessment | Unexpected, significant, unrelated to the study. |
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| Small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment | Unexpected, significant, unrelated to the study. |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment | Unexpected, significant, unrelated to the study. |
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| Pericardial Effusion | Cardiac disorders | Non-systematic Assessment | Unexpected, significant, unrelated to the study. |
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| hematoma with non-occlusive DVT | Blood and lymphatic system disorders | Non-systematic Assessment | hematoma with non-occlusive DVT |
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| Acute appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
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| right ureteral stone | Renal and urinary disorders | Non-systematic Assessment | Unexpected, significant, unrelated to the study. |
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| Leg swelling | General disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| Right hip pain | General disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| Total hip replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| Abdominal pain | General disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| Thyroid cancer recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| Ventral hernia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| Seizure | General disorders | Non-systematic Assessment |
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| general musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| lumbar spine surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| Syncope | Metabolism and nutrition disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| COVID-19 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| body swelling | General disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| wound infection | Infections and infestations | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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| wrist injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unexpected, insignificant, unrelated to the study. |
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Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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