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Completed

NCT Number: NCT05183217

Tailoring Online Continence Promotion

This project seeks to understand whether, and how, tailoring an online continence intervention can increase engagement and uptake of health behaviors known to improve bladder and bowel symptoms.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

About this study

The investigators will conduct a two-arm, parallel, randomized, controlled trial (RCT) comparing an online continence promotion program with standard weekly reminders (control arm) to an online continence promotion program with tailoring (treatment arm) to determine the impact of tailoring on program engagement. Women in the treatment arm will receive tailored content and digital reminders for 24 weeks based on their individual characteristics, symptoms, and behaviors assessed at baseline, with reassessment of key inputs every 2 weeks resulting in re-tailored outputs. Participants will complete electronic surveys at enrollment, 4, 12, and 24 weeks. To contextualize the findings from all 3 aims, a subset of participants will be invited to complete semi-structured qualitative interviews about their engagement with the program, their adoption of health behaviors, and their perceived barriers to and facilitators of engagement and behavior change.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • 50 years or older
  • Can read & write English
  • Can use email
  • Has access to an Internet-connected device to use the online program

Exclusion criteria

  • Dementia
  • Neurologic or musculoskeletal conditions in which pelvic floor muscle exercises are contraindicated
  • Hematuria or bloody stools within last 6 months that has not been evaluated by a medical professional

Treatment and study plan

Online Continence promotion program without tailoring

Behavioral

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.

Other names: Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online without tailoring

Online Continence promotion program with tailoring

Behavioral

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.

Other names: Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online with tailoring

Primary outcomes

  1. User Engagement With Online Mind Over Matter (MOM)

    Time frame: 0-4 weeks

    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.

Secondary outcomes

  1. Self-reported Behavior Changes: Change in the Frequency of Pelvic Floor Muscle Exercises

    Time frame: Baseline, 4, 12, and 24 weeks

    Frequency of pelvic floor muscle exercises

  2. Differences in Scores of the Geriatric Index for Urinary Incontinence (GSE-UI)

    Time frame: Baseline, 4, and 24 weeks

    The 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.

  3. Differences in Responses to the Generalized Self-Efficacy Scale Adapted for MOM Program

    Time frame: Baseline, 4, and 24 weeks

    Previously, 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.

  4. Program Specific Health Action Process Approach Survey Responses Reported as Binary Outcomes

    Time frame: Baseline, 4, and 24 weeks

    Number 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.

  5. Differences in Scores of the Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q)

    Time frame: Baseline and 24 weeks

    The 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.

  6. Differences in Scores of the Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)

    Time frame: Baseline and 24 weeks

    The 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.

  7. Differences in Scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)

    Time frame: Baseline, 4, 12, and 24 weeks

    ICIQ-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)

  8. Differences in Scores of the St. Mark's Incontinence Scale (SMIS) (Aka Vaizey)

    Time frame: Baseline, 4, 12, and 24 weeks

    St. 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

  9. Differences in Scores of the Pelvic Floor Impact Questionnaire Short Form (PFIQ-7)

    Time frame: Baseline, 4, 12, and 24 weeks

    The 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.

  10. Change in the Response of Global Patient Satisfaction Question (PSQ)

    Time frame: 4 and 24 weeks

    Patient satisfaction will be measured with the question: How satisfied are you with your progress in this program? (completely, some-what, not at all)

  11. Change in Patient Estimated Percent Improvement (EPI)

    Time frame: 4 and 24 weeks

    For EPI, Patients will be asked to estimate how much better they were on a scale from 0% (no better) to 100%(completely better)

  12. Change in Response on Global Perception of Improvement (GPI)

    Time frame: 4 and 24 weeks

    Global 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

  13. Differences in Scores of the 12-item Short Form Health Survey (SF-12)

    Time frame: Baseline, 4, 12, and 24 weeks

    The 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.

Other outcomes

  1. Program Use Metrics

    Time frame: Baseline to 24 weeks

    Comparison 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).

  2. Self-reported Behavior Changes: Change in Body Mass Index (BMI)

    Time frame: Baseline, 4, 12, and 24 weeks

    Proportion 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.

  3. Self-reported Behavior Changes: Change in Fluid Intake

    Time frame: Baseline, 4, 12, and 24 weeks

    Self-reported behavior changes: fluid intake

  4. Self-reported Behavior Changes: Change in Fiber Intake

    Time frame: Baseline, 4, 12, and 24 weeks

    Self-reported behavior changes: change in fiber intake

  5. Self-reported Coping Changes: Change in Types of Pad Used

    Time frame: Baseline, 4, 12, and 24 weeks

    Self-reported coping changes: change in types of pad used

  6. Self-reported Coping Changes: Change in Number of Pads Used

    Time frame: Baseline, 4, 12, and 24 weeks

    Self-reported coping changes: change in number of pads used

  7. Self-reported Changes: Change in the Money-spent on Buying Products to Manage Their Incontinence

    Time frame: Baseline, 4, 12, and 24 weeks

    It 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Tailoring Online Continence Promotion for Women

Acronym: TOCP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2022
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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