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CompletadoNCT05050266Registro de ClinicalTrials.gov

Enhancing Mental and Physical Health of Women Veterans

Cardiovascular Diseases · Overweight · Obesity · Smoking · Hypertension · Cholesterol · Diabetes Mellitus · Prediabetic State · Pregnancy · Depression, Postpartum · Prevention · Implementation Science · Quality Improvement · Virtual Care

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
No especificado - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
20 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

Women Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.

Leer la descripción completa

Women Veterans are the fastest-growing segment of users in the Veterans Health Administration (VA). Their numbers are projected to increase by 73%, from 9.3% to 16.4%, between 2015 and 2043. Despite VA investment in improving care for women Veterans, gender disparities persist in cardiovascular (CV) and diabetes risk factor control. Also, the rate of perinatal depression among women Veterans is higher than that among civilian women, which is of particular concern given the association between perinatal depression and suicidality. Barriers to care for women Veterans include distance to VA care, rurality, competing work and caregiving responsibilities, comorbid mental health issues, and harassment on VA grounds. Improvements are still needed to increase women Veterans' access to and engagement in convenient, safe, evidence-based, patient-centered care that achieves the VA "lane of effort" of Veterans' "lifelong health, well-being, and resilience."

Since its inception in 2015, the Enhancing Mental and Physical health of Women through Engagement and Retention (EMPOWER) QUERI 1.0 team has focused on implementing gender-tailored care models for women Veteran patients. In EMPOWER 1.0 studies, women expressed preferences for gender-specific (women only) care and for virtual care options. Therefore, the EMPOWER 2.0 Impact Goal is to expand access to virtual, evidence-based, preventive lifestyle and mental health services for women Veterans with high-priority health conditions in rural and urban-isolation areas. This cluster randomized type 3 hybrid implementation-effectiveness trial randomized 20 VA sites to one of two implementation strategies, the Replicating Effective Practices (REP) or Evidence-Based Quality Improvement (EBQI), to support implementation and sustainment of evidence-based practices (EBPs). The EBPs focus on preventive lifestyle and mental health care for women Veterans across VA facilities, several of which are rural, low-performing in women's health care, and/or lead sites for high reliability organization. The study team will conduct a mixed methods implementation evaluation to compare the effectiveness of REP and EBQI in terms of: (a) improved access to and rates of engagement in virtual preventive lifestyle and mental health services and improved VA performance metrics for virtual and telehealth care delivery and related clinical outcomes for women Veterans; (b) progression along the Stages of Implementation Completion; (c) adaptation, sense-making, and experiences of EBP implementation among multilevel stakeholders; and (d) cost and return on investment.

On 8/15/23, as part of our 12 month registration update corrected the primary outcomes to accurately reflect the randomized trial and analyses design. The cluster randomized trial will evaluate the effectiveness of two implementation strategies (REP and EBQI) in implementing evidence-based practices (EBPs) for preventive services. Although we are implementing three evidence-based practices (DPP, TLC and ROSE), the EBPs are combined for each of the trial's two primary outcomes (access and engagement).

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

This study is recruiting VA sites - not individual patients. Prior to randomization, the study team will work with sites to ensure they have met the preconditions necessary to enroll in the study, which includes VISN, regional and/or facility level leadership support for participation.

Exclusion Criteria:

N/A

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Asignación al azar
Enmascaramiento
Sin enmascaramiento
REP

Replicating Effective Practices (REP) is a lower-intensity implementation strategy with explicit process framework for local tailoring

Behavioral: REP

EBQI

Evidence-Based Quality Improvement (EBQI) is a higher-intensity implementation strategy that entails external facilitation and formal training in quality improvement.

Behavioral: EBQI

EBQI BEHAVIORAL

EBQI is a systematic quality improvement method for engaging frontline practices in improvement that introduces "best science" and evidence in the service of operational goals. EBQI has been tested in several VA implementation trials. Sites randomized to EBQI will meet monthly with the implementation support team (i.e., high-intensity).

REP BEHAVIORAL

The REP framework consists of 4 phases: pre-conditions, pre-implementation, implementation and maintenance/evolution. REP has a strong evidence-base and application in VHA health services research in promoting uptake of EBPs. Sites randomized to REP will meet quarterly with the implementation support team (i.e., low-intensity).

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Access to virtual care for preventive services

Plazo: 12 months

Proportion of eligible women Veterans who enroll in virtual DPP, TLC, or ROSE at each site

Engagement in virtual care for preventive services

Plazo: 12 months

Proportion of eligible women Veterans who attend 1 or more virtual DPP, TLC, or ROSE sessions at each site

Medidas secundarias

Participation and engagement: DPP

Plazo: 6 and 12 months

average # of sessions attended by women Veterans who enrolled in DPP at each site

Participation and engagement: DPP

Plazo: 6 and 12 months

proportion who completed \>9 and \>16 sessions among women Veterans who enrolled in DPP at each site

Participation and engagement: DPP

Plazo: 6 and 12 months

% weight change among women Veterans who enrolled in DPP at each site

Participation and engagement: TLC

Plazo: 6 months

average # of TLC sessions completed among women Veterans who enrolled in TLC at each site

Participation and engagement: TLC

Plazo: 6 months

% with health behavioral goal among women Veterans who enrolled in TLC at each site

Participation and engagement: TLC

Plazo: 6 months

% with behavioral change (physical activity, diet: fruit, vegetable and sugary beverage intake, stress and coping, and weight) at each site

Participation and engagement: ROSE

Plazo: 6 months

average # of ROSE sessions completed at each site

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, California, United StatesEstado desconocido

Equipo y fechas

Patrocinador principal
VA Office of Research and Development
Inicio del estudio
21 oct 2021 Real
Finalización primaria
30 oct 2026 Real
Finalización del estudio
30 oct 2026 Real
Primera publicación
20 sept 2021 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

Enhancing Mental and Physical Health of Women Through Engagement and Retention (EMPOWER) QUERI 2.0 (QUE 20-028)

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

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No incluyas expedientes médicos, diagnósticos, medicamentos, números de seguro ni otros datos sensibles. Este formulario es para preguntas generales, no para atención urgente.

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026