Tailoring Online Continence Promotion (TOCP)

University of Wisconsin (UW)

Status: Completed

Conditions: Urinary Incontinence in Old Age; Fecal Incontinence in Old Age

Treatments: Behavioral: Online Continence promotion program without tailoring; Behavioral: Online Continence promotion program with tailoring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05183217

1R01DK128349-01 (U.S. NIH Grant/Contract)

Protocol Version 12/10/2021 (Other Identifier)

A532800 (Other Identifier)

2021-1555

Details and patient eligibility

About

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.

Full 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.

Enrollment: 445 patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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445 participants in 2 patient groups

Online continence promotion program without tailoring

Active Comparator group

Description:

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

Treatment:

Behavioral: Online Continence promotion program without tailoring

Online continence promotion program with tailoring

Experimental group

Description:

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

Treatment:

Behavioral: Online Continence promotion program with tailoring