Tailoring Online Continence Promotion

NCT05183217 | Completed Results DMC

• 4 other identifiers: 2021-15551R01DK128349-01A532800Protocol Version 12/10/2021
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence in Old Age; Fecal Incontinence in Old Age

Outcome Measures

Primary Outcomes (1)

• User Engagement With Online Mind Over Matter (MOM)

  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.

  0-4 weeks

Secondary Outcomes (13)

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

  Baseline, 4, 12, and 24 weeks

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

  Baseline, 4, and 24 weeks

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

  Baseline, 4, and 24 weeks

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

  Baseline, 4, and 24 weeks

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

  Baseline and 24 weeks

Other Outcomes (7)

• Program Use Metrics

  Baseline to 24 weeks

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

  Baseline, 4, 12, and 24 weeks

• Self-reported Behavior Changes: Change in Fluid Intake

  Baseline, 4, 12, and 24 weeks

Study Arms (2)

Online continence promotion program without tailoring

ACTIVE COMPARATOR

Participants will be allocated to the online continence promotion program without tailoring.

Behavioral: Online Continence promotion program without tailoring

Online continence promotion program with tailoring

EXPERIMENTAL

Participants will be allocated to the online continence promotion program with tailoring.

Behavioral: Online Continence promotion program with tailoring

Interventions

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.

Also known as: Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online without tailoring

Online continence promotion program 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.

Also known as: Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online with tailoring

Online continence promotion program with tailoring

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Results Point of Contact

• Title: Heidi Brown
• Organization: University of Wisconsin - Madison

heidi.w.brown@kp.org

619-695-4714

Study Officials

• Megan Piper, PhD

  University of Wisconsin Dept of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: November 30, 2023
• Primary Completion: May 8, 2024
• Study Completion: September 25, 2024
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)