Trial Outcomes & Findings for Improving Care for Women With Urinary Incontinence (EMPOWER) (NCT NCT05515198)
NCT ID: NCT05515198
Last Updated: 2026-05-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each wave
Results posted on
2026-05-05
Participant Flow
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.
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.
Unit of analysis: Practices
Participant milestones
| Measure |
Arm 1
Patient Education
|
Arm 2
Patient Education + Nurse Navigation
|
Arm 3
Patient Education + Nurse Navigation + ChatBot
|
|---|---|---|---|
|
Overall Study
STARTED
|
158 26
|
139 25
|
103 25
|
|
Overall Study
COMPLETED
|
148 26
|
130 25
|
90 25
|
|
Overall Study
NOT COMPLETED
|
10 0
|
9 0
|
13 0
|
Reasons for withdrawal
| Measure |
Arm 1
Patient Education
|
Arm 2
Patient Education + Nurse Navigation
|
Arm 3
Patient Education + Nurse Navigation + ChatBot
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
10
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
3
|
Baseline Characteristics
Improving Care for Women With Urinary Incontinence (EMPOWER)
Baseline characteristics by cohort
| Measure |
Arm 1
n=158 Participants
Patient Education
|
Arm 2
n=139 Participants
Patient Education + Nurse Navigation
|
Arm 3
n=103 Participants
Patient Education + Nurse Navigation + ChatBot
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=54 Participants
|
87 Participants
n=60 Participants
|
69 Participants
n=114 Participants
|
256 Participants
n=37 Participants
|
|
Age, Categorical
>=65 years
|
58 Participants
n=54 Participants
|
52 Participants
n=60 Participants
|
34 Participants
n=114 Participants
|
144 Participants
n=37 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=54 Participants
|
139 Participants
n=60 Participants
|
103 Participants
n=114 Participants
|
400 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
18 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
142 Participants
n=54 Participants
|
131 Participants
n=60 Participants
|
96 Participants
n=114 Participants
|
369 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
13 Participants
n=37 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
4 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
3 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=54 Participants
|
18 Participants
n=60 Participants
|
25 Participants
n=114 Participants
|
75 Participants
n=37 Participants
|
|
Race (NIH/OMB)
White
|
113 Participants
n=54 Participants
|
109 Participants
n=60 Participants
|
74 Participants
n=114 Participants
|
296 Participants
n=37 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
10 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
12 Participants
n=37 Participants
|
|
BMI
|
33 kg/m^2
STANDARD_DEVIATION 9 • n=54 Participants
|
30 kg/m^2
STANDARD_DEVIATION 7 • n=60 Participants
|
35 kg/m^2
STANDARD_DEVIATION 9 • n=114 Participants
|
32 kg/m^2
STANDARD_DEVIATION 8 • n=37 Participants
|
PRIMARY outcome
Timeframe: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each waveThe 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.
Outcome measures
| Measure |
Arm 2
n=139 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=158 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=103 Participants
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.
|
|---|---|---|---|
|
Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Baseline
|
9.0 score on a scale
Standard Deviation 4.4
|
8.4 score on a scale
Standard Deviation 4.5
|
9.9 score on a scale
Standard Deviation 4.4
|
|
Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Month 2
|
7.2 score on a scale
Standard Deviation 3.7
|
8.9 score on a scale
Standard Deviation 4.4
|
7.1 score on a scale
Standard Deviation 4.1
|
|
Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Month 6
|
6.3 score on a scale
Standard Deviation 3.7
|
8.7 score on a scale
Standard Deviation 4.6
|
6.3 score on a scale
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=25 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=40 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=27 Participants
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.
|
|---|---|---|---|
|
Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
|
5.1 score on a scale
Standard Deviation 3.9
|
7.7 score on a scale
Standard Deviation 4.3
|
5.2 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=18 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=9 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=9 Participants
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.
|
|---|---|---|---|
|
Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
|
6.5 score on a scale
Standard Deviation 4.9
|
8.7 score on a scale
Standard Deviation 2.7
|
8.7 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each WavePopulation: the means and standard deviations are based on the observed/non-missing responses, so n varies.
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.
Outcome measures
| Measure |
Arm 2
n=139 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=158 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=103 Participants
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.
|
|---|---|---|---|
|
Change in Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI
Baseline
|
18.2 score on a scale
Standard Deviation 5.0
|
18.2 score on a scale
Standard Deviation 5.1
|
18.2 score on a scale
Standard Deviation 4.5
|
|
Change in Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI
Month 2
|
20.4 score on a scale
Standard Deviation 4.4
|
18.8 score on a scale
Standard Deviation 5.3
|
21.0 score on a scale
Standard Deviation 4.0
|
|
Change in Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI
Month 6
|
20.8 score on a scale
Standard Deviation 4.2
|
19.2 score on a scale
Standard Deviation 5.4
|
21.4 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=24 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=38 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=26 Participants
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.
|
|---|---|---|---|
|
Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI
|
21.0 score on a scale
Standard Deviation 4.3
|
21.1 score on a scale
Standard Deviation 4.3
|
21.6 score on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=17 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=9 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=9 Participants
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.
|
|---|---|---|---|
|
Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI
|
19.9 score on a scale
Standard Deviation 3.9
|
18.3 score on a scale
Standard Deviation 7.4
|
23.9 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline (immediately prior to start of intervention) in all WavesPatient empowerment will be measured by a patient survey to measure with percentage of patients answering yes to speaking with their provider about UI.
Outcome measures
| Measure |
Arm 2
n=118 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=129 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=98 Participants
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.
|
|---|---|---|---|
|
Patient Empowerment as Measured by Number of Participants That Answered Yes to Speaking With Their Provider About UI.
|
25 Participants
|
24 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each WavePopulation: 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.
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.
Outcome measures
| Measure |
Arm 2
n=139 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=158 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=103 Participants
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.
|
|---|---|---|---|
|
Change in Overactive Bladder Symptom Severity as Measured by the OABSS
Baseline
|
6.07 score on a scale
Standard Deviation 3.08
|
6.2 score on a scale
Standard Deviation 3.19
|
6.53 score on a scale
Standard Deviation 3.24
|
|
Change in Overactive Bladder Symptom Severity as Measured by the OABSS
Month 2
|
4.6 score on a scale
Standard Deviation 2.9
|
5.4 score on a scale
Standard Deviation 3.2
|
3.7 score on a scale
Standard Deviation 2.7
|
|
Change in Overactive Bladder Symptom Severity as Measured by the OABSS
Month 6
|
3.88 score on a scale
Standard Deviation 2.59
|
4.84 score on a scale
Standard Deviation 2.77
|
3.70 score on a scale
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=23 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=39 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=26 Participants
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.
|
|---|---|---|---|
|
Overactive Bladder Symptom Severity as Measured by the OABSS
|
3.74 score on a scale
Standard Deviation 2.72
|
4.31 score on a scale
Standard Deviation 2.44
|
3.46 score on a scale
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 and 3 participants)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=17 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=10 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=9 Participants
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.
|
|---|---|---|---|
|
Overactive Bladder Symptom Severity as Measured by the OABSS
|
4.2 score on a scale
Standard Deviation 3.6
|
4.4 score on a scale
Standard Deviation 3.1
|
5.0 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each WavePopulation: 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
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.
Outcome measures
| Measure |
Arm 2
n=135 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=132 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=97 Participants
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.
|
|---|---|---|---|
|
Change in Urinary Symptoms as Measured by the UDI-6
Baseline
|
38 score on a scale
Standard Deviation 16
|
39 score on a scale
Standard Deviation 18
|
43 score on a scale
Standard Deviation 20
|
|
Change in Urinary Symptoms as Measured by the UDI-6
Month 2
|
26 score on a scale
Standard Deviation 15
|
33 score on a scale
Standard Deviation 18
|
25 score on a scale
Standard Deviation 19
|
|
Change in Urinary Symptoms as Measured by the UDI-6
Month 6
|
20 score on a scale
Standard Deviation 11
|
30 score on a scale
Standard Deviation 17
|
21 score on a scale
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=24 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=38 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=27 Participants
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.
|
|---|---|---|---|
|
Urinary Symptoms as Measured by the UDI-6
|
18 score on a scale
Standard Deviation 18
|
29 score on a scale
Standard Deviation 19
|
17 score on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=17 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=10 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=10 Participants
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.
|
|---|---|---|---|
|
Urinary Symptoms as Measured by the UDI-6
|
24 score on a scale
Standard Deviation 22
|
26 score on a scale
Standard Deviation 14
|
32 score on a scale
Standard Deviation 11
|
SECONDARY outcome
Timeframe: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each WavePopulation: 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
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.
Outcome measures
| Measure |
Arm 2
n=128 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=122 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=95 Participants
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.
|
|---|---|---|---|
|
Change in Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol
Baseline
|
34 score on a scale
Standard Deviation 9
|
35 score on a scale
Standard Deviation 10
|
37 score on a scale
Standard Deviation 10
|
|
Change in Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol
Month 2
|
30 score on a scale
Standard Deviation 8
|
34 score on a scale
Standard Deviation 11
|
31 score on a scale
Standard Deviation 10
|
|
Change in Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol
Month 6
|
27 score on a scale
Standard Deviation 7
|
34 score on a scale
Standard Deviation 10
|
30 score on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=22 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=39 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=26 Participants
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.
|
|---|---|---|---|
|
Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol
|
26 score on a scale
Standard Deviation 6
|
32 score on a scale
Standard Deviation 12
|
27 score on a scale
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=16 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=7 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=10 Participants
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.
|
|---|---|---|---|
|
Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol
|
29 score on a scale
Standard Deviation 8
|
35 score on a scale
Standard Deviation 9
|
33 score on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Months 2 and 6 post start of intervention in each WavePopulation: 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
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.
Outcome measures
| Measure |
Arm 2
n=99 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=99 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=74 Participants
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.
|
|---|---|---|---|
|
Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.
Month 2
|
40 Participants
|
9 Participants
|
35 Participants
|
|
Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.
Month 6
|
33 Participants
|
10 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=23 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=40 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=27 Participants
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.
|
|---|---|---|---|
|
Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.
|
11 Participants
|
7 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Arm 2
n=17 Participants
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=9 Participants
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=10 Participants
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.
|
|---|---|---|---|
|
Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.
|
10 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 month post completion of each Wave's enrollment period (7 months from beginning of screening period of each Wave)Population: Only practices, and not participants, were analyzed for this Outcome Measure
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.
Outcome measures
| Measure |
Arm 2
n=15 Practices
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=26 Practices
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=36 Practices
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.
|
|---|---|---|---|
|
Number of Practices That Maintain a UI Management Intervention as Measured by the Practice Survey
|
2 Practices
|
3 Practices
|
2 Practices
|
SECONDARY outcome
Timeframe: 1 month post completion of each Wave's enrollment period (7 months from beginning of screening for each Wave)Population: Only practices, and not participants, were analyzed for this Outcome Measure
Implementation of a UI point person will be measured as a percentage of sites answer yes on practice survey.
Outcome measures
| Measure |
Arm 2
n=15 Practices
Patient Education + Nurse Navigation
Patient Education: Patients will be provided educational opportunities.
Nurse Navigation: A nurse navigator will work with the participants to help them navigate the care pathway. The navigator will provide education and recommendations for treatment options.
|
Arm 1
n=26 Practices
Patient Education
Patient Education: Patients will be provided educational opportunities.
|
Arm 3
n=36 Practices
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.
|
|---|---|---|---|
|
Number of Practices That Implement a UI Point Person as Measured by the Practice Survey
|
0 Practices
|
2 Practices
|
2 Practices
|
Adverse Events
Arm 1
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 2
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm 3
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=158 participants at risk
Patient Education
|
Arm 2
n=139 participants at risk
Patient Education + Nurse Navigation
|
Arm 3
n=103 participants at risk
Patient Education + Nurse Navigation + ChatBot
|
|---|---|---|---|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.63%
1/158 • Number of events 1 • 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
|
0.00%
0/139 • 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
|
0.00%
0/103 • 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
|
|
Gastrointestinal disorders
gastric ulcers
|
0.63%
1/158 • Number of events 1 • 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
|
0.00%
0/139 • 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
|
0.00%
0/103 • 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
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/158 • 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
|
0.72%
1/139 • Number of events 1 • 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
|
0.00%
0/103 • 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
|
|
Vascular disorders
Cerebrovascular accident (CVA)
|
0.00%
0/158 • 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
|
0.72%
1/139 • Number of events 1 • 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
|
0.00%
0/103 • 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
|
|
Gastrointestinal disorders
Cholecystitis
|
0.00%
0/158 • 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
|
0.72%
1/139 • Number of events 1 • 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
|
0.00%
0/103 • 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
|
|
Cardiac disorders
Chest pain
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
|
Renal and urinary disorders
Pyelonephritis of right kidney
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
|
Blood and lymphatic system disorders
hematoma with non-occlusive DVT
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Acute appendicitis
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
|
Renal and urinary disorders
right ureteral stone
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
Other adverse events
| Measure |
Arm 1
n=158 participants at risk
Patient Education
|
Arm 2
n=139 participants at risk
Patient Education + Nurse Navigation
|
Arm 3
n=103 participants at risk
Patient Education + Nurse Navigation + ChatBot
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis
|
0.63%
1/158 • Number of events 1 • 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
|
0.72%
1/139 • Number of events 1 • 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
|
0.00%
0/103 • 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
|
|
Gastrointestinal disorders
Hemoptysis
|
0.63%
1/158 • Number of events 1 • 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
|
0.00%
0/139 • 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
|
0.00%
0/103 • 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
|
|
General disorders
Leg swelling
|
0.63%
1/158 • Number of events 1 • 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
|
0.00%
0/139 • 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
|
0.00%
0/103 • 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
|
|
General disorders
Right hip pain
|
0.63%
1/158 • Number of events 1 • 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
|
0.00%
0/139 • 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
|
0.00%
0/103 • 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
|
|
Musculoskeletal and connective tissue disorders
Total hip replacement
|
0.63%
1/158 • Number of events 1 • 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
|
0.00%
0/139 • 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
|
0.00%
0/103 • 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
|
|
General disorders
Abdominal pain
|
1.3%
2/158 • Number of events 3 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer recurrence
|
0.63%
1/158 • Number of events 1 • 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
|
0.00%
0/139 • 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
|
0.00%
0/103 • 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
|
|
Musculoskeletal and connective tissue disorders
Ventral hernia
|
0.63%
1/158 • Number of events 1 • 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
|
0.00%
0/139 • 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
|
0.00%
0/103 • 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
|
|
General disorders
Seizure
|
0.63%
1/158 • Number of events 1 • 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
|
0.00%
0/139 • 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
|
0.00%
0/103 • 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
|
|
Musculoskeletal and connective tissue disorders
general musculoskeletal pain
|
1.3%
2/158 • Number of events 2 • 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
|
2.2%
3/139 • Number of events 3 • 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
|
1.9%
2/103 • Number of events 2 • 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
|
|
Musculoskeletal and connective tissue disorders
lumbar spine surgery
|
0.00%
0/158 • 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
|
0.72%
1/139 • Number of events 1 • 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
|
0.00%
0/103 • 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
|
|
Metabolism and nutrition disorders
Syncope
|
0.00%
0/158 • 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
|
1.4%
2/139 • Number of events 2 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/158 • 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
|
0.72%
1/139 • Number of events 1 • 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
|
0.00%
0/103 • 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
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
0.00%
0/158 • 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
|
0.72%
1/139 • Number of events 1 • 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
|
0.00%
0/103 • 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
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
1.9%
2/103 • Number of events 2 • 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
|
|
General disorders
body swelling
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
|
Infections and infestations
wound infection
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
|
Musculoskeletal and connective tissue disorders
wrist injury
|
0.00%
0/158 • 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
|
0.00%
0/139 • 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
|
0.97%
1/103 • Number of events 1 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place