Recruiting

MyHealtheBladder

Sponsor:

VA Office of Research and Development

Code:

NCT07219433

Conditions

Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Implementation Strategy: Foundational Arm

Implementation Strategy: REACH Arm

Study Details

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.

Conditions

Urinary Incontinence

Study ID

NCT07219433

Start date

Apr 30, 2026

Status verified date

May, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Sep 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Site Inclusion Criteria:

  • Facility is part of the U.S. Department of Veterans Affairs (VA) health system.
  • Clinic serves at least 100 Women Veterans annually.
  • Identified site champion (e.g., clinician or staff member) who is willing to assume required program responsibilities for implementation.

Patient Inclusion Criteria:

  • Women Veterans
  • Have any type of Urinary Incontinence existing for at least 3 months

Exclusion Criteria:

Site Exclusion Criteria:

  • Clinic has already implemented the MyHealtheBladder program.

Patient Exclusion Criteria:

  • No access to computer or mobile device
  • No email account
  • Institutionalized

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

Implementation Strategy: Foundational Arm

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

The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports, a data dashboard, and external facilitation.

Primary outcome measure

  • Reach [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Caitlin B Kappler, MSW

(919) 286-6936Caitlin.Kappler@va.gov

Locations

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Heidi D Bassani

(919) 286-0411Heidi.Bassani@va.gov

Principal Investigator:

Karen Goldstein, MD MSPH

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Veterans
  • Implementation Science
  • Functional Status
  • Quality of Life
  • Mobile Applications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-22.