NCT03976414

Brief Summary

The objective of this study is to (1) use participatory ergonomics to adapt and in-person 3-session intervention: Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM) to an electronic program (eMOM), and to (2) compare and characterize eMOM's reach when marketed via community agencies versus Facebook advertising and to collect qualitative and quantitative data about effectiveness and uptake of key behaviors using electronic surveys and phone interviews. The study will also collect information from community agencies that might implement eMOM about its perceived value and their willingness and capacity to implement such a program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

August 22, 2025

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

May 6, 2019

Last Update Submit

August 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Response on global perception of improvement (GPI) tool at 4 months

    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

    4 months

Secondary Outcomes (11)

  • Change in the response of Global patient satisfaction question (PSQ)

    1 month, 4 months, 6 months

  • Change in patient estimated percent improvement (EPI)

    1 month, 4 months, 6 months

  • Change in response on global perception of improvement (GPI) at 1 month and 6 months

    1 month, 6 month

  • Differences in scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)

    Baseline, 1 month, 4 month, 6 month

  • Differences in scores of the St. Mark's Incontinence Scale (aka Vaizey)

    baseline, 1 month, 4 month, 6 month

  • +6 more secondary outcomes

Study Arms (1)

eMOM website users

Any woman who visits the "research" tab on the eMOM website will see an invitation to participate in a research study about the impact of the website on her bladder and bowel symptoms. Women may use the intervention (the website) regardless of whether they opt to participate in the research study. The intervention is the use of the website (eMOM), which is the electronic adaption of the program, Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM), a small-group, community-based health promotion program that builds skills and self-efficacy to make behavior changes that improve urinary and bowel symptoms among older women with incontinence.

Other: eMOM

Interventions

eMOMOTHER

The intervention is the use of the website (eMOM), which is the electronic adaption of the program, Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM), a small-group, community-based health promotion program that builds skills and self-efficacy to make behavior changes that improve urinary and bowel symptoms among older women with incontinence.

Also known as: Mind Over Matter: Healthy Bowels, Healthy Bladder" (MOM)
eMOM website users

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

While eMOM will be promoted specifically for older women, women of any age may access the program and participate in the study if they so choose.

You may qualify if:

  • be able to access the eMOM website via internet
  • must be able to speak and read English
  • at least 18 years old
  • female.

You may not qualify if:

  • no access to internet
  • no email address

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Urinary IncontinenceEncopresis

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • Heidi Brown, MD

    UW-Madison Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

June 6, 2019

Study Start

June 1, 2019

Primary Completion

March 1, 2020

Study Completion

May 31, 2020

Last Updated

August 22, 2025

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations