An interventional study of Patient Education and Nurse Navigation in Urinary Incontinence, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 400 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
None
Patient Education
Other: Patient Education
Patient Education + Nurse Navigation
Other: Patient Education · Other: Nurse Navigation
Patient Education + Nurse Navigation + ChatBot
Other: Patient Education · Other: Nurse Navigation · Other: ChatBot
Patients will be provided educational opportunities.
Also known as: Education
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.
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.
Also known as: Behavioral/exercise via chatbot
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.
Time frame: 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.
Time frame: 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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month post completion of each Wave's enrollment period (7 months from beginning of screening for each Wave)
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.
| Milestone | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Started | 158 | 139 | 103 |
| Completed | 148 | 130 | 90 |
| Not completed | 10 | 9 | 13 |
| Withdrew: Lost to follow-up | 8 | 5 | 10 |
| Withdrew: Withdrawal by subject | 2 | 4 | 3 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Baseline | 8.4 ± 4.5 | 9.0 ± 4.4 | 9.9 ± 4.4 |
| Month 2 | 8.9 ± 4.4 | 7.2 ± 3.7 | 7.1 ± 4.1 |
| Month 6 | 8.7 ± 4.6 | 6.3 ± 3.7 | 6.3 ± 4.2 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | 7.7 ± 4.3 | 5.1 ± 3.9 | 5.2 ± 2.8 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | 8.7 ± 2.7 | 6.5 ± 4.9 | 8.7 ± 5.4 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Baseline | 18.2 ± 5.1 | 18.2 ± 5.0 | 18.2 ± 4.5 |
| Month 2 | 18.8 ± 5.3 | 20.4 ± 4.4 | 21.0 ± 4.0 |
| Month 6 | 19.2 ± 5.4 | 20.8 ± 4.2 | 21.4 ± 4.2 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI | 21.1 ± 4.3 | 21.0 ± 4.3 | 21.6 ± 4.9 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI | 18.3 ± 7.4 | 19.9 ± 3.9 | 23.9 ± 1.8 |
Patient empowerment will be measured by a patient survey to measure with percentage of patients answering yes to speaking with their provider about UI.
| Participants | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Patient Empowerment as Measured by Number of Participants That Answered Yes to Speaking With Their Provider About UI. | 24 | 25 | 22 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Baseline | 6.2 ± 3.19 | 6.07 ± 3.08 | 6.53 ± 3.24 |
| Month 2 | 5.4 ± 3.2 | 4.6 ± 2.9 | 3.7 ± 2.7 |
| Month 6 | 4.84 ± 2.77 | 3.88 ± 2.59 | 3.70 ± 2.49 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Overactive Bladder Symptom Severity as Measured by the OABSS | 4.31 ± 2.44 | 3.74 ± 2.72 | 3.46 ± 2.28 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Overactive Bladder Symptom Severity as Measured by the OABSS | 4.4 ± 3.1 | 4.2 ± 3.6 | 5.0 ± 3.0 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Baseline | 39 ± 18 | 38 ± 16 | 43 ± 20 |
| Month 2 | 33 ± 18 | 26 ± 15 | 25 ± 19 |
| Month 6 | 30 ± 17 | 20 ± 11 | 21 ± 16 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Urinary Symptoms as Measured by the UDI-6 | 29 ± 19 | 18 ± 18 | 17 ± 12 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Urinary Symptoms as Measured by the UDI-6 | 26 ± 14 | 24 ± 22 | 32 ± 11 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Baseline | 35 ± 10 | 34 ± 9 | 37 ± 10 |
| Month 2 | 34 ± 11 | 30 ± 8 | 31 ± 10 |
| Month 6 | 34 ± 10 | 27 ± 7 | 30 ± 10 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol | 32 ± 12 | 26 ± 6 | 27 ± 7 |
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.
| score on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol | 35 ± 9 | 29 ± 8 | 33 ± 8 |
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.
| Participants | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Month 2 | 9 | 40 | 35 |
| Month 6 | 10 | 33 | 30 |
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.
| Participants | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. | 7 | 11 | 16 |
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.
| Participants | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale. | 1 | 10 | 5 |
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.
| Practices | Wave 1 | Wave 2 | Wave 3 |
|---|---|---|---|
| Number of Practices That Maintain a UI Management Intervention as Measured by the Practice Survey | 3 | 2 | 2 |
Implementation of a UI point person will be measured as a percentage of sites answer yes on practice survey.
| Practices | Wave 1 | Wave 2 | Wave 3 |
|---|---|---|---|
| Number of Practices That Implement a UI Point Person as Measured by the Practice Survey | 2 | 0 | 2 |
Collected over 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. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | 0/158 (0%) | 2/158 (1.3%) | 11/158 (7%) |
| Arm 2 | 0/139 (0%) | 3/139 (2.2%) | 9/139 (6.5%) |
| Arm 3 | 0/103 (0%) | 5/103 (4.9%) | 9/103 (8.7%) |
| Event | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Chest painCardiac disorders | 0/158 | 0/139 | 1/103 |
| Pyelonephritis of right kidneyRenal and urinary disorders | 0/158 | 0/139 | 1/103 |
| Small bowel obstructionGastrointestinal disorders | 0/158 | 0/139 | 1/103 |
| FallInjury, poisoning and procedural complications | 0/158 | 0/139 | 1/103 |
| Pericardial EffusionCardiac disorders | 0/158 | 0/139 | 1/103 |
| hematoma with non-occlusive DVTBlood and lymphatic system disorders | 0/158 | 0/139 | 1/103 |
| Acute appendicitisGastrointestinal disorders | 0/158 | 0/139 | 1/103 |
| right ureteral stoneRenal and urinary disorders | 0/158 | 0/139 | 1/103 |
| Suicide AttemptPsychiatric disorders | 0/158 | 1/139 | 0/103 |
| Cerebrovascular accident (CVA)Vascular disorders | 0/158 | 1/139 | 0/103 |
| Event | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| general musculoskeletal painMusculoskeletal and connective tissue disorders | 2/158 | 3/139 | 2/103 |
| Urinary tract infectionRenal and urinary disorders | 0/158 | 0/139 | 2/103 |
| SyncopeMetabolism and nutrition disorders | 0/158 | 2/139 | 1/103 |
| Abdominal painGeneral disorders | 2/158 | 0/139 | 1/103 |
| body swellingGeneral disorders | 0/158 | 0/139 | 1/103 |
| wound infectionInfections and infestations | 0/158 | 0/139 | 1/103 |
| wrist injuryMusculoskeletal and connective tissue disorders | 0/158 | 0/139 | 1/103 |
| GastroenteritisGastrointestinal disorders | 1/158 | 1/139 | 0/103 |
| lumbar spine surgeryMusculoskeletal and connective tissue disorders | 0/158 | 1/139 | 0/103 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/158 | 1/139 | 0/103 |
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.
| Age, Categorical(Participants) | Arm 1 | Arm 2 | Arm 3 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 100 | 87 | 69 | 256 |
| >=65 years | 58 | 52 | 34 | 144 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Arm 3 | Total |
|---|---|---|---|---|
| Female | 158 | 139 | 103 | 400 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1 | Arm 2 | Arm 3 | Total |
|---|---|---|---|---|
| Hispanic or Latino | 8 | 6 | 4 | 18 |
| Not Hispanic or Latino | 142 | 131 | 96 | 369 |
| Unknown or Not Reported | 8 | 2 | 3 | 13 |
| Race (NIH/OMB)(Participants) | Arm 1 | Arm 2 | Arm 3 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 3 | 0 | 4 |
| Asian | 1 | 2 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 32 | 18 | 25 | 75 |
| White | 113 | 109 | 74 | 296 |
| More than one race | 3 | 3 | 4 | 10 |
| Unknown or Not Reported | 8 | 4 | 0 | 12 |
| BMI(kg/m^2) | Arm 1 | Arm 2 | Arm 3 | Total |
|---|---|---|---|---|
| Mean | 33 ± 9 | 30 ± 7 | 35 ± 9 | 32 ± 8 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All of the individual participant data collected during the trial will be made available after de-identification.
Supporting information: Study protocol, Sap, Icf, Csr
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University Hospitals Cleveland Medical Center