Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT07219433
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.
Study:
NCT07219433
Study Brief:
Protocol Section:
NCT07219433