Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875, United States
Location status: Recruiting
Location contact
Heidi D Bassani
CONTACT
Karen Goldstein, MD MSPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07219433
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.
Interested in participating?
Request InfoFemale
Interventional
Not applicable
Durham, North Carolina, 27705-3875, United States
Location status: Recruiting
Heidi D Bassani
CONTACT
Karen Goldstein, MD MSPH
PRINCIPAL_INVESTIGATOR
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.
MyHealtheBladder (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 MHB 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 aim to develop scalable approaches for implementing and sustaining use of MyHealtheBladder in clinical settings. Additionally, they will assess the reach of MyHealtheBladder when delivered through the Foundational arm compared to an enhanced-implementation strategy, the REACH (Reach Equity And Collective Health) arm.
Key questions. How can the REACH arm be optimized to implement MHB across all patients who would benefit? What are shareholder perspectives on refinements needed for MHB foundational activities, as well as strategies to enhance equitable reach? To address the question "Are there differences in implementation outcomes (reach [primary], patient engagement, time to adoption) between arms?", the investigators will use generalized linear models to examine the effect of foundational vs. REACH on implementation outcomes of reach and patient engagement at 12 and 18 months (primary). Average time to adoption will be compared between study arms.
Methodology. To evaluate implementation, the investigators will randomize sites (n=20) 1:1 to either the foundational arm or REACH arm. The investigators will use generalized linear models to examine the effect of foundational vs. REACH on implementation outcomes of reach and patient engagement at 18 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Site Inclusion Criteria:
Patient Inclusion Criteria:
Exclusion criteria
Site Exclusion Criteria:
Patient Exclusion Criteria:
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.
Time frame: 18 months
Reach will be defined as the percentage of Women Veterans that accessed (logged into) the MHB app.
Time frame: 12 months
Reach will be defined as the percentage of Women Veterans that accessed (logged into) the MHB app.
Time frame: 12 months
Patient engagement will be defined as the proportion of MyHealtheBladder sessions completed by Women Veterans at each clinic, among those who completed at least one session.
Time frame: 18 months
Patient engagement will be defined as the proportion of MyHealtheBladder sessions completed by Women Veterans at each clinic, among those who completed at least one session.
Time frame: 18 months
Time to Adoption will be defined as the time from baseline to the time at which a site crosses the adoption threshold (5 or more Women Veterans who have accessed the app). This will be computed for each site meeting the adoption criteria.
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
Implementing a Mobile Health Application for Women Veterans With Urinary Incontinence: MyHealtheBladder in Function QUERI 3.0 (QUE 25-008)
Acronym: MHB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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