Tailoring Online Continence Promotion

NCT ID: NCT05183217

Last Updated: 2025-05-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

445 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2024-09-25

Brief Summary

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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

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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.

Conditions

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Urinary Incontinence in Old Age Fecal Incontinence in Old Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Online continence promotion program without tailoring

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

Group Type ACTIVE_COMPARATOR

Online Continence promotion program without tailoring

Intervention Type 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.

Online continence promotion program with tailoring

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

Group Type EXPERIMENTAL

Online Continence promotion program with tailoring

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online without tailoring Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online with tailoring

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan Piper, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Dept of Medicine

Locations

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University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01DK128349-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A532800

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 12/10/2021

Identifier Type: OTHER

Identifier Source: secondary_id

2021-1555

Identifier Type: -

Identifier Source: org_study_id

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