Implementing a Mobile Health Application for Women Veterans With Urinary Incontinence (MyHealtheBladder): Function QUERI 3.0
MHB
1 other identifier
interventional
20
1 country
1
Brief Summary
Implementing a Mobile Health Application for Women Veterans with Urinary Incontinence (MyHealtheBladder): Function QUERI 3.0 aims to compare implementation approaches while also gathering information on clinical effects of the Evidence-Based Program (EBP) in its new context and focusing on equitable reach (extent to which the program serves all members of its intended audience). The overall goal is to implement, evaluate, and sustain MyHealtheBladder in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel cluster randomized trial (CRT) design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
1 active site
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
October 17, 2025
CompletedFirst Posted
Study publicly available on registry
October 21, 2025
CompletedStudy Start
First participant enrolled
April 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2030
May 7, 2026
May 1, 2026
4.4 years
October 17, 2025
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reach
Reach will be defined as the percentage of Women Veterans that accessed (logged into) the MHB app.
18 months
Secondary Outcomes (4)
Reach
12 months
Patient Engagement
12 months
Patient Engagement
18 months
Time to Adoption
18 months
Study Arms (2)
Foundational Arm
ACTIVE COMPARATORThe Foundational Arm uses the Replicating Effective Program (REP) implementation strategy and includes 3 elements that were developed and tested in the investigators' prior Function QUERI work: program initiation, self-guided resources, and technical assistance.
REACH (Reach Equity And Collective Health) Arm
EXPERIMENTALThe REACH Arm will include the same activities as the foundational arm plus REACH activities: 1) external facilitation and 2) equity-focused data-driven monitoring.
Interventions
The Foundational Arm includes the following activities: Program sign up, toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, and site specific data reports.
The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports, a data dashboard, and external facilitation.
Eligibility Criteria
You may qualify if:
- Facility is part of the U.S. Department of Veterans Affairs (VA) health system.
- Clinic serves at least 100 Women Veterans annually.
- Clinic is located 25 miles from the nearest other VA clinic participating in the program.
- Identified site champion (e.g., clinician or staff member) who is willing to assume required program responsibilities for implementation.
- Women Veterans
- Have any type of Urinary Incontinence existing for at least 3 months
You may not qualify if:
- Clinic has already implemented the MyHealtheBladder program.
- No access to computer or mobile device
- No email account
- Institutionalized
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Goldstein, MD MSPH
Durham VA Medical Center, Durham, NC
- PRINCIPAL INVESTIGATOR
Alayne D Markland, DO MSc
Birmingham VA Medical Center, Birmingham, AL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2025
First Posted
October 21, 2025
Study Start
April 30, 2026
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
September 30, 2030
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Available upon request.
- Access Criteria
- Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.
A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored \& maintained in an approved, secured location as described in the VA Research Data Inventory Form. The statistician will create de-identified, publication-specific datasets that includes variables from statistical models presented in publication. Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.