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Incontinence, UrinaryNCT03976414

Mind Over Matter: Electronic Bladder and Bowel Continence Self-management Program

An observational study of Incontinence, Urinary and Incontinence Bowel, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years, women onlyHealthy volunteers can take part
Conditions the study is for
Incontinence, Urinary, Incontinence Bowel
What is being tested?
eMOM
How many people
260 participants
Where
1 siteUnited States
Study dates
1 Jun 2019to 31 May 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • no access to internet
  • no email address

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin-Madison School of Medicine and Public Health

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Reach and Teach: Translating "Mind Over Matter: Healthy Bowels, Healthy Bladder" for Digital Delivery

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.

Read the detailed description

More than half of patients hospitalized with serious illness rated urinary and bowel incontinence as a state worse than death in a 2016 JAMA (The Journal of the American Medical Association) internal medicine study - worse than relying on a breathing machine, being unable to get out of bed, or being confused all the time. Unfortunately, over 60% of community-dwelling women over age 65 suffer from urinary and/or bowel incontinence, accounting for a combined annual cost in excess of $30 billion. In addition to their impact on quality of life, social isolation, and depression, urinary and bowel incontinence increase caregiver burnout, risk for falls, hospitalization, and nursing home placement. However, despite the existence of effective treatments, over half of women with urinary incontinence and two-thirds of women with bowel incontinence do not seek medical care. Interventions to promote continence in healthcare settings thus reach fewer than half of those in need.

At University of Wisconsin, research team developed "Mind Over Matter: Healthy Bowels, Healthy Bladder" (MOM), which is 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. Delivered by a trained facilitator, MOM allows senior women to improve their symptoms without seeking medical care. In the randomized, controlled trial (RCT) including 122 women in 6 Wisconsin communities, more than 70% of participants (versus 23% of controls, p<.0001) achieved improvement in urinary incontinence and 55% (versus 26% of controls, p = .0015) achieved improvement in bowel incontinence three months following completion of the program, corresponding to a number-needed-to-treat of 3 for urinary incontinence improvement and 4 for bowel incontinence improvement.

However, community-based, in-person programs like MOM continue to suffer limited adoption, implementation, and reach. Many agencies that adopt and implement such health promotion programs are under-resourced and often staffed by volunteers. To ensure intervention fidelity, programs like MOM require a large commitment from their resource-stressed hosting agencies. Implemented using a "train the trainer" approach organized by the Wisconsin Institute for Healthy Aging (WIHA), MOM requires community facilitators to attend a 2-day training and then run the workshop series at least twice annually. In addition to the 2-day training, it requires approximately 24 person-hours to offer a single MOM workshop series. If the trained facilitator leaves or is redirected to other activities, the community agency can no longer implement or maintain the program without sending another staff member to be trained. In addition to these hurdles at the organization level, there are barriers at the individual level.

In a recent collaboration with the Survey of the Health of Wisconsin (SHOW), it was observed that fewer than 20% of women with incontinence (mean age 55 years old) reported being likely to attend a continence promotion program with the current, in-person MOM format. In qualitative interviews, women expressed concerns about the time commitment, caregiver responsibilities at home, issues related to travel (inclement weather, excessive distance to reach a community center), and privacy, given the sensitive nature of incontinence. In contrast, 65% of women with incontinence reported being likely to participate in an electronic continence promotion program, increasing potential reach three-fold.

Adaptation of the in-person MOM workshop to an electronic format (eMOM) has the potential to overcome both individual and organizational hurdles, maximizing reach and minimizing barriers to consistent implementation and maintenance. Women with incontinence can complete the modules in privacy, at their convenience, and at their own pace. In contrast to the commitment required for a community agency to implement the in-person MOM workshop, eMOM can be implemented using whatever strategies the agency uses to share other electronic resources with their members. eMOM can also be implemented via mass media, such as Facebook. Women age 65+ account for 11.6% of all Facebook users, and there are more than 200,000 monthly active users in this demographic in Wisconsin alone.

The proposed research will provide invaluable information about the feasibility and reach of implementing an electronic health promotion program through mass media versus through existing community agencies - information applicable not just to continence promotion but also to other health promotion programs trying to overcome similar barriers to reach, implementation, and maintenance.

Being tested
eMOM
Medical subject headings
Urinary Incontinence, Encopresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eMOMOther

    Also called Mind Over Matter: Healthy Bowels, Healthy Bladder" (MOM)

    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.

Study groups in NCT03976414
Study groupRoleWhat they receive
eMOM website usersAny 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.
Receives: Other: eMOM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 months

Secondary outcomes (11)
  1. Change in the response of Global patient satisfaction question (PSQ)

    Patient satisfaction will be measured with the question: How satisfied are you with your progress in this program? (completely, some-what, not at all)

    Measured: 1 month, 4 months, 6 months

  2. Change in patient estimated percent improvement (EPI)

    For EPI, Patients will be asked to estimate how much better they were on a scale from 0% (no better) to 100%(completely better)

    Measured: 1 month, 4 months, 6 months

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

    Measured: 1 month, 6 month

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

    ICIQ-UI is a subjective measure of severity of urinary loss and quality of life for those with urinary incontinence. It is scored on a scale from 0-21. Based on the score participant can be placed in four severity categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21)

    Measured: Baseline, 1 month, 4 month, 6 month

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

    St. Mark's Incontinence Scale (aka Vaizey) will be used to assess the severity and the outcome of MOM intervention

    Never: no episodes in the past 4 weeks rarely: 1 episode in the past 4 weeks sometimes: > 1 episode in the past 4 weeks, but,1 a week; Weekly: 1 or more episodes a week but,1 a day Daily: 1 or more episodes a day

    Scores will be assigned for each row (Never=0, Rarely=1, Sometimes=2, Weekley=3, Daily=4 )

    Score will be added from each row. Cumulative minimum score=0 perfect continence; Cumulative maximum score will be 24= totally incontinence

    Measured: baseline, 1 month, 4 month, 6 month

  6. Self-reported behavior changes: change in the frequency of pelvic floor muscle exercises

    Frequency of pelvic floor muscle exercises

    Measured: baseline, 1 month, 4 month, 6 month

  7. Self-reported behavior changes: change in fluid intake

    Self-reported behavior changes: fluid intake

    Measured: baseline, 1 month, 4 month, 6 month

  8. Self-reported behavior changes: change in fiber intake

    Self-reported behavior changes: change in fiber intake

    Measured: baseline, 1 month, 4 month, 6 month

  9. Self-reported coping changes: change in types of pad used

    Self-reported coping changes: change in types of pad used

    Measured: baseline, 1 month, 4 month, 6 month

  10. Self-reported coping changes: change in number of pads used

    Self-reported coping changes: change in number of pads used

    Measured: baseline, 1 month, 4 month, 6 month

  11. Self-reported changes: change in the money-spent on buying products to manage their incontinence

    It will be measured by asking participants question that how much money have they spent on products (such as pads, undergarments, or plugs) to manage their bladder and/or bowel symptoms in the last month.

    Measured: baseline, 1 month, 4 month, 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2019
  2. Study start1 Jun 2019
  3. Primary completion1 Mar 2020
  4. Study completion31 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03976414
Sponsor's protocol ID
2018-1147
Other IDs
SMPH/OBSTET & GYNECOL/OBSTET &, A532800
Status last verified
Sep 2020
First submitted
6 May 2019
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Incontinence, Urinary and Incontinence Bowel, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response on global perception of improvement (GPI) tool at 4 months (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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