Implementing a Mobile Health Application for Women Veterans With Urinary Incontinence (MyHealtheBladder): Function QUERI 3.0

Part of paid clinical trials in Durham, North Carolina.

Sponsor
VA Office of Research and Development
Study ID
NCT07219433
Status
Recruiting
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Conditions

  • Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Implementation Strategy: Foundational Arm — OTHER
    The Foundational Arm includes the following activities: Program sign up, toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, and site specific data reports.
  • Implementation Strategy: REACH Arm — OTHER
    The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports, a data dashboard, and external facilitation.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Foundational Arm
    The 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.
  • Experimental: REACH (Reach Equity And Collective Health) Arm
    The REACH Arm will include the same activities as the foundational arm plus REACH activities: 1) external facilitation and 2) equity-focused data-driven monitoring.

Primary Outcome Measure

Reach [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875
Heidi D Bassani
[email protected]
(919) 286-0411
Karen Goldstein, MD MSPH (PRINCIPAL_INVESTIGATOR)

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