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

NCT ID: NCT07219433

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-10-01
• Study Completion Date: 2030-09-30

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 EBP in its new context and focusing on equitable reach (extent to which the program serves its intended audience). The overall goal is to address a key priority within the implementation science field - identifying and refining metrics for equity and impact. 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 CRT design.

Detailed Description

Background/Purpose. Urinary incontinence (UI) is a highly prevalent condition among women, especially as they age, and can directly impair quality of life, daily function, and long-term independence. Evidence-based behavioral management approaches are first-line treatment for UI; these include treatments such as pelvic floor muscle training, fluid management, and bladder control and voiding strategies. Despite being prevalent and burdensome, UI is often unrecognized and undertreated.

MHB is an interactive mobile health application designed to deliver evidence-based behavioral self-management instruction specifically for women Veterans (WV). In a multi-site RCT (VA IIR HX002827) conducted in VA (n=286) comparing MyHealtheBladder to video visits via VA Video Connect (VVC) delivered by a trained Continence Care provider, MHB resulted in equivalent or greater improvements in UI symptoms and satisfaction compared with VVC. Engagement in MHB was high, with 70% retention and an average of 58 miles saved per Veteran. MHB does not require a clinical visit and has the potential to scale across other VA facilities and generate healthcare savings while maintaining comparable patient-level outcomes to individual clinical encounters.

Objectives. The investigators plan to develop scalable approaches to implement and sustain MyHealtheBladder as well as evaluate reach with foundational support versus the enhanced-implementation strategy (Reach+Equity bundle).

Key questions. How can the Reach+Equity bundle be optimized to implement MHB? What are shareholder perspectives on refinements needed for MHB foundational REP activities, as well as strategies to enhance equitable reach (Reach+Equity bundle)? Are there differences in implementation outcomes (reach, adoption, fidelity, cost) between arms? What are patient-level effectiveness outcomes (urinary symptom severity, quality of life, satisfaction with treatment) among WV who enroll, and do these differ between arms? Are there changes in UI diagnosis rates at implementing sites, and between arms? To address the question: Are there differences in implementation outcomes (reach [primary], fidelity, adoption) between arms? The investigators will use generalized linear models to examine the effect of foundational REP vs. Reach+Equity on implementation outcomes of reach and fidelity at 6, 12, and 18-months (primary). To address the question: Are there differences in effectiveness outcomes (UI severity, QoL, satisfaction) between arms? The investigators will describe effectiveness/quality outcomes for WVs who enroll in MHB, overall and by study arm. Linear mixed effect models including all time points for patient outcomes will be fit to account for clustering of WV within site and repeated measures of patient outcomes.

Methodology. To evaluate implementation, the investigators will randomize sites (n=20) 1:1 to either foundational support or foundational support plus the Reach+Equity bundle. The investigators will use generalized linear models to examine the effect of foundational vs. Reach+Equity on implementation outcomes at 18-months.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Foundational Support

Foundational Support uses the Replicating Effective Program (REP) implementation strategy and includes 5 elements that were developed and tested in our prior Function QUERI work: shareholder engagement, MHB toolkit, Online shared resources (SharePoint) access for clinical program training materials, data reports to assist sites with tracking their data, and Diffusion Networks to promote peer-to-peer sharing and implementation support.

Group Type: ACTIVE_COMPARATOR

Implementation Strategy: Foundational Support

Intervention Type: OTHER

The primary goal of MHB is to compare implementation approaches while also gathering information on clinical effects of the EBP in its new context. All sites will be randomized to receive 1) foundational REP implementation support alone or 2) foundational REP and Reach+Equity. We propose that low intensity implementation support that promotes engagement with the MHB app (defined as foundational support), will be sufficient for some but not all facilities to successfully incorporate MHB into routine practice.

Reach+Equity Bundle

The Reach+Equity bundle will include the same activities as foundational support plus the Reach+Equity bundle activities which include: 1) external facilitation (provide an outside perspective to help sites identify barriers, develop effective strategies, and navigate complex change processes particularly through the lens of achieving equitable reach); 2) equity in implementation toolkit (guide that supports awareness and consideration of health equity during the implementation process); and 3) equity-focused data-driven monitoring (inform progress regarding equitable reach-related goals).

Group Type: EXPERIMENTAL

Implementation Strategy: Reach+Equity Bundle

Intervention Type: OTHER

We hypothesize that adding the Reach+Equity bundle to foundational REP, compared to foundational REP alone, will result in superior implementation outcomes.

Interventions

Implementation Strategy: Foundational Support

The primary goal of MHB is to compare implementation approaches while also gathering information on clinical effects of the EBP in its new context. All sites will be randomized to receive 1) foundational REP implementation support alone or 2) foundational REP and Reach+Equity. We propose that low intensity implementation support that promotes engagement with the MHB app (defined as foundational support), will be sufficient for some but not all facilities to successfully incorporate MHB into routine practice.

Intervention Type: OTHER

Implementation Strategy: Reach+Equity Bundle

We hypothesize that adding the Reach+Equity bundle to foundational REP, compared to foundational REP alone, will result in superior implementation outcomes.

Intervention Type: OTHER

Other Intervention Names

Foundatiional REP; Enhanced Support

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Goldstein, MD MSPH

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Alayne D Markland, DO MSc

Role: PRINCIPAL_INVESTIGATOR

Birmingham VA Medical Center, Birmingham, AL

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

Central Contacts

Caitlin B Kappler, MSW

Role: CONTACT

Caitlin.Kappler@va.gov

(919) 286-6936

Facility Contacts

Heidi D Bassani

Role: primary

Heidi.Bassani@va.gov

(919) 286-0411

Other Identifiers

QUX 25-003

Identifier Type: -

Identifier Source: org_study_id