Implementing a Mobile Health Application for Women Veterans With Urinary Incontinence (MyHealtheBladder): Function QUERI 3.0
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Implementation Strategy: Foundational Arm, Implementation Strategy: REACH Arm.
- Кому может быть актуально
- Состояния в реестре: Urinary Incontinence. Базовые параметры: Без ограничений · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Implementing a Mobile Health Application for Women Veterans With Urinary Incontinence: MyHealtheBladder in Function QUERI 3.0 (QUE 25-008)
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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. - Другое 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.
Первичные конечные точки
- Reach [Срок оценки: 18 months]
Вторичные конечные точки (4)
- Reach [Срок оценки: 12 months]
- Patient Engagement [Срок оценки: 12 months]
- Patient Engagement [Срок оценки: 18 months]
- Time to Adoption [Срок оценки: 18 months]
Критерии участия
Критерии включения
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
Критерии исключения
Site Exclusion Criteria:
- Clinic has already implemented the MyHealtheBladder program.
Patient Exclusion Criteria:
- No access to computer or mobile device
- No email account
- Institutionalized
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- Durham VA Medical Center, Durham, NC — Durham
Идентификаторы
NCT: NCT07219433 · QUX 25-003