Clinical trial NCT03976414: Mind Over Matter: Electronic Bladder and Bowel Continence Self-management Program
Official title: Reach and Teach: Translating "Mind Over Matter: Healthy Bowels, Healthy Bladder" for Digital Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incontinence, Urinary
Incontinence Bowel
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* no access to internet
* no email address

Primary outcomes:
measure: Response on global perception of improvement (GPI) tool at 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Change in the response of Global patient satisfaction question (PSQ)
timeFrame: 1 month, 4 months, 6 months
measure: Change in patient estimated percent improvement (EPI)
timeFrame: 1 month, 4 months, 6 months
measure: Change in response on global perception of improvement (GPI) at 1 month and 6 months
timeFrame: 1 month, 6 month
measure: Differences in scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)
timeFrame: Baseline, 1 month, 4 month, 6 month
measure: Differences in scores of the St. Mark's Incontinence Scale (aka Vaizey)
timeFrame: baseline, 1 month, 4 month, 6 month
measure: Self-reported behavior changes: change in the frequency of pelvic floor muscle exercises
timeFrame: baseline, 1 month, 4 month, 6 month
measure: Self-reported behavior changes: change in fluid intake
timeFrame: baseline, 1 month, 4 month, 6 month
measure: Self-reported behavior changes: change in fiber intake
timeFrame: baseline, 1 month, 4 month, 6 month
measure: Self-reported coping changes: change in types of pad used
timeFrame: baseline, 1 month, 4 month, 6 month
measure: Self-reported coping changes: change in number of pads used
timeFrame: baseline, 1 month, 4 month, 6 month
measure: Self-reported changes: change in the money-spent on buying products to manage their incontinence
timeFrame: baseline, 1 month, 4 month, 6 month
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: UW-Madison Obstetrics and Gynecology
name: Heidi Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: