Trial Outcomes & Findings for Tailoring Online Continence Promotion (NCT NCT05183217)
NCT ID: NCT05183217
Last Updated: 2025-05-25
Results Overview
Proportion of participants who engage with online MOM at least 4 times during weeks 0-4 in the group with (test) and without (control) tailoring.
COMPLETED
NA
445 participants
0-4 weeks
2025-05-25
Participant Flow
Participant milestones
| Measure |
Online Continence Promotion Program Without Tailoring
Participants will be allocated to the online continence promotion program without tailoring.
Online Continence promotion program without tailoring: The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above. Participants will receive automated weekly reminders reminding them to re-visit the program, regardless of their individual user activity.
|
Online Continence Promotion Program With Tailoring
Participants will be allocated to the online continence promotion program with tailoring.
Online Continence promotion program with tailoring: The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above. Participants will receive tailored "output" (personalized cues, emphasis on relevant content, individualized and tailored reminders about their goals) based on a computer algorithm incorporating unique user "inputs" (individual factors). Inputs will be reassessed every 2 weeks for retailoring so that personalization evolves over the course of the intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
219
|
|
Overall Study
COMPLETED
|
225
|
218
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Online Continence Promotion Program Without Tailoring
Participants will be allocated to the online continence promotion program without tailoring.
Online Continence promotion program without tailoring: The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above. Participants will receive automated weekly reminders reminding them to re-visit the program, regardless of their individual user activity.
|
Online Continence Promotion Program With Tailoring
Participants will be allocated to the online continence promotion program with tailoring.
Online Continence promotion program with tailoring: The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above. Participants will receive tailored "output" (personalized cues, emphasis on relevant content, individualized and tailored reminders about their goals) based on a computer algorithm incorporating unique user "inputs" (individual factors). Inputs will be reassessed every 2 weeks for retailoring so that personalization evolves over the course of the intervention.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Tailoring Online Continence Promotion
Baseline characteristics by cohort
| Measure |
Online Continence Promotion Program Without Tailoring
n=226 Participants
Participants will be allocated to the online continence promotion program without tailoring.
Online Continence promotion program without tailoring: The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above. Participants will receive automated weekly reminders reminding them to re-visit the program, regardless of their individual user activity.
|
Online Continence Promotion Program With Tailoring
n=219 Participants
Participants will be allocated to the online continence promotion program with tailoring.
Online Continence promotion program with tailoring: The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above. Participants will receive tailored "output" (personalized cues, emphasis on relevant content, individualized and tailored reminders about their goals) based on a computer algorithm incorporating unique user "inputs" (individual factors). Inputs will be reassessed every 2 weeks for retailoring so that personalization evolves over the course of the intervention.
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Total
n=445 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
58 years
n=7 Participants
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
226 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
445 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
219 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
174 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
226 participants
n=5 Participants
|
219 participants
n=7 Participants
|
444 participants
n=5 Participants
|
|
Height
|
165 Centimeters
n=5 Participants
|
165 Centimeters
n=7 Participants
|
165 Centimeters
n=5 Participants
|
|
Weight
|
77 kilograms
n=5 Participants
|
75 kilograms
n=7 Participants
|
76 kilograms
n=5 Participants
|
|
Body mass index
|
28 kg/m^2
n=5 Participants
|
27 kg/m^2
n=7 Participants
|
27.5 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-4 weeksProportion of participants who engage with online MOM at least 4 times during weeks 0-4 in the group with (test) and without (control) tailoring.
Outcome measures
| Measure |
Online Continence Promotion Program Without Tailoring
n=226 Participants
The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above. Participants will receive automated weekly reminders reminding them to re-visit the program, regardless of their individual user activity.
|
Online Continence Promotion Program With Tailoring
n=219 Participants
The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above.
Participants will receive tailored "output" (personalized cues, emphasis on relevant content, individualized and tailored reminders about their goals) based on a computer algorithm incorporating unique user "inputs" (individual factors). Inputs will be reassessed every 2 weeks for retailoring so that personalization evolves over the course of the intervention.
|
|---|---|---|
|
User Engagement With Online Mind Over Matter (MOM)
|
17 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Baseline, 4, 12, and 24 weeksFrequency of pelvic floor muscle exercises
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, and 24 weeksThe Geriatric Index for Urinary Incontinence (GSE-UI) is a validated and clinically responsive instrument for older women with urinary incontinence. Participants select a 0-10 score for each of the 12 items, with total scores ranging from 0-120. A higher score is indicative of a higher level of self-efficacy related to urinary incontinence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, and 24 weeksPreviously, in consultation with Dr. Ralf Schwarzer (Health Action Process Approach developer), the investigators adapted the Generalized Self Efficacy scale for behaviors related to continence promotion (such as pelvic floor muscle exercises).10-items are scored on a 4 point likert scale from 1 (not true at all) to 4 (exactly true) for a total range of scores from 10-40 where higher scores indicate higher self-efficacy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, and 24 weeksNumber of Participants who report high vs low risk perception, positive vs negative outcome expectations, specific intentions, action or coping plans, barriers and facilitators for health on the program-specific survey of other Health Action Process Approach components.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 24 weeksThe Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q) contains 14-items framed on a 4-point Likert scale and is validated in women with urinary incontinence. Mean score will be reported, ranging from 1-4 where higher scores indicate increased barriers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 24 weeksThe Barriers to Care-seeking for Accidental Bowel Leakage (BCABL) has been validated in women with bowel incontinence. BCABL contains 16 questions framed on a 4-point Likert scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree), for a total possible range of scores from 16-64 where higher scores indicate increased barriers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 12, and 24 weeksICIQ-UI is a subjective measure of severity of urinary loss and quality of life for those with urinary incontinence. It is scored on a scale from 0-21. Based on the score participant can be placed in four severity categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 12, and 24 weeksSt. Mark's Incontinence Scale (aka Vaizey) will be used to assess the severity and the outcome of MOM intervention Never: no episodes in the past 4 weeks rarely: 1 episode in the past 4 weeks sometimes: \> 1 episode in the past 4 weeks, but,1 a week; Weekly: 1 or more episodes a week but,1 a day Daily: 1 or more episodes a day Scores will be assigned for each row (Never=0, Rarely=1, Sometimes=2, Weekly=3, Daily=4 ) Score will be added from each row. Cumulative minimum score=0 perfect continence; Cumulative maximum score will be 24= totally incontinence
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 12, and 24 weeksThe Pelvic Floor Impact Questionnaire Short Form (PFIQ-7) is a widely-used validated instrument that assesses condition-specific quality of life. Scores range from 0-300 with higher scores indicating higher symptom bother.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 and 24 weeksPatient satisfaction will be measured with the question: How satisfied are you with your progress in this program? (completely, some-what, not at all)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 and 24 weeksFor EPI, Patients will be asked to estimate how much better they were on a scale from 0% (no better) to 100%(completely better)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 and 24 weeksGlobal perception of improvement (GPI) is a tool for Global Rating of Patient Satisfaction and Perceptions of Improvement. Question asked: Overall, do you feel that you are? Response can be chosen from the options: Much Better, Better, About the same, Worse, Much worse
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 12, and 24 weeksThe 12-item Short Form Health Survey (SF-12) is a validated health-related quality of life questionnaire from which mental and physical component scores can be calculated. Scores on the PCS-12 (Physical Score): range from 23.99938 (difference from USA average: -26.00062) to 56.57706 (difference from USA average: 6.57706). Scores on the MCS-12 (Mental Score): range from 19.06444 (difference from USA average: -30.93556) to 60.75781 (difference from USA average: 10.75781). For both components, higher scores indicate better health-related quality of life.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 24 weeksComparison of specific program use metrics (number of, minutes spent on, and average intervals between program sessions accessed weekly; number of and specific components accessed) between the two groups and patterns of program use (such as tracking and reminders).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4, 12, and 24 weeksProportion of participants in the treatment group compared to the control group with a body mass index (BMI) \>25mg/kg2 at baseline who report weight loss of at least 2 kg.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4, 12, and 24 weeksSelf-reported behavior changes: fluid intake
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4, 12, and 24 weeksSelf-reported behavior changes: change in fiber intake
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4, 12, and 24 weeksSelf-reported coping changes: change in types of pad used
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4, 12, and 24 weeksSelf-reported coping changes: change in number of pads used
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4, 12, and 24 weeksIt will be measured by asking participants question that how much money have they spent on products (such as pads, undergarments, or plugs) to manage their bladder and/or bowel symptoms in the last month.
Outcome measures
Outcome data not reported
Adverse Events
Online Continence Promotion Program Without Tailoring
Online Continence Promotion Program With Tailoring
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place