Clinical trial NCT05183217: Tailoring Online Continence Promotion
Official title: Tailoring Online Continence Promotion for Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence in Old Age
Fecal Incontinence in Old Age
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-01-10
Enrollment: 445
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: User Engagement With Online Mind Over Matter (MOM)
timeFrame: 0-4 weeks
Secondary outcomes:
measure: Self-reported Behavior Changes: Change in the Frequency of Pelvic Floor Muscle Exercises
timeFrame: Baseline, 4, 12, and 24 weeks
measure: Differences in Scores of the Geriatric Index for Urinary Incontinence (GSE-UI)
timeFrame: Baseline, 4, and 24 weeks
measure: Differences in Responses to the Generalized Self-Efficacy Scale Adapted for MOM Program
timeFrame: Baseline, 4, and 24 weeks
measure: Program Specific Health Action Process Approach Survey Responses Reported as Binary Outcomes
timeFrame: Baseline, 4, and 24 weeks
measure: Differences in Scores of the Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q)
timeFrame: Baseline and 24 weeks
measure: Differences in Scores of the Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)
timeFrame: Baseline and 24 weeks
measure: Differences in Scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)
timeFrame: Baseline, 4, 12, and 24 weeks
measure: Differences in Scores of the St. Mark's Incontinence Scale (SMIS) (Aka Vaizey)
timeFrame: Baseline, 4, 12, and 24 weeks
measure: Differences in Scores of the Pelvic Floor Impact Questionnaire Short Form (PFIQ-7)
timeFrame: Baseline, 4, 12, and 24 weeks
measure: Change in the Response of Global Patient Satisfaction Question (PSQ)
timeFrame: 4 and 24 weeks
measure: Change in Patient Estimated Percent Improvement (EPI)
timeFrame: 4 and 24 weeks
measure: Change in Response on Global Perception of Improvement (GPI)
timeFrame: 4 and 24 weeks
measure: Differences in Scores of the 12-item Short Form Health Survey (SF-12)
timeFrame: Baseline, 4, 12, and 24 weeks
Other outcomes:
measure: Program Use Metrics
timeFrame: Baseline to 24 weeks
measure: Self-reported Behavior Changes: Change in Body Mass Index (BMI)
timeFrame: Baseline, 4, 12, and 24 weeks
measure: Self-reported Behavior Changes: Change in Fluid Intake
timeFrame: Baseline, 4, 12, and 24 weeks
measure: Self-reported Behavior Changes: Change in Fiber Intake
timeFrame: Baseline, 4, 12, and 24 weeks
measure: Self-reported Coping Changes: Change in Types of Pad Used
timeFrame: Baseline, 4, 12, and 24 weeks
measure: Self-reported Coping Changes: Change in Number of Pads Used
timeFrame: Baseline, 4, 12, and 24 weeks
measure: Self-reported Changes: Change in the Money-spent on Buying Products to Manage Their Incontinence
timeFrame: Baseline, 4, 12, and 24 weeks
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Dept of Medicine
name: Megan Piper, PhD
role: PRINCIPAL_INVESTIGATOR
References: