Implementing a Mobile Health Application for Women Veterans With Urinary Incontinence: MyHealtheBladder in Function QUERI 3.0 (QUE 25-008)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reach
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Site Exclusion Criteria:
- •Clinic has already implemented the MyHealtheBladder program.
- •Patient Exclusion Criteria:
- •No access to computer or mobile device
- •No email account
- •Institutionalized
研究组 & 干预措施
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.
干预措施: Implementation Strategy: Foundational Arm (Other)
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.
干预措施: Implementation Strategy: REACH Arm (Other)
结局指标
主要结局
Reach
时间窗: 18 months
Reach will be defined as the percentage of Women Veterans that accessed (logged into) the MHB app.
次要结局
- Reach(12 months)
- Patient Engagement(12 months)
- Patient Engagement(18 months)
- Time to Adoption(18 months)