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Uso de una aplicación electrónica centrada en el paciente para aumentar el conocimiento del paciente de urgencias sobre el VHC para mejorar la continuidad de la atención del VHC

28 de septiembre de 2026 actualizado por: Johns Hopkins University

Uso de una aplicación electrónica centrada en el paciente para aumentar el conocimiento de los pacientes del departamento de emergencias sobre la infección por el VHC, la progresión de la enfermedad y la atención para mejorar la continuidad de la atención del VHC

The investigators will conduct a randomized controlled clinical trial study in an urban emergency department in Baltimore to determine the impact of an educational app which is based on Leventhal's Common-Sense Model of Illness Representations framework, on HCV-infected ED patient's hepatitis C virus (HCV) health belief and knowledge as well as the downstream outcomes of the HCV Continuum of Care (linkage to care rate, initiation of HCV antiviral treatment, and sustained virologic response). First, the investigators will develop a blueprinted prototype personalized HCV educational app which will (1) provide individualized liver fibrosis staging information, (2) pre-test HCV knowledge, perception of barriers to HCV care, and motivation to receive HCV care survey, (3) provide personalized HCV knowledge, facilitators and supporting information for HCV care via video clips and information sheets based on the pre-test results, and (4) provide post-test knowledge, perception, and motivation to receive HCV care. Second, the investigators will conduct a series of focus group discussion sessions to fine-tune the HCV educational app. Third, the investigators will enroll ED patients who have anti-HCV (newly diagnosed or previously diagnosed) but without HCV RNA testing information for a pilot randomized controlled clinical trial of the personalized HCV educational app.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

An estimated 40-85% of 2.4 million Americans infected with HCV remain unaware of the infection. Further even amongst those aware of the HCV status, the vast majority do not get linked to care or are offered the option for treatment. Busy emergency department (ED) settings, which provide care to 140 million individuals each year, have recently been demonstrated to be a key venue for large-scale HCV testing, with outcomes from several large cities showing rates of disease of upwards of 10%. Significant challenges remain however, as linkage to care (LTC) from EDs has proven particularly elusive. National ED HCV LTC rates typically range from 20-40%, which dramatically restricts the overall impact on patient outcomes. Varied and complex factors contribute to these challenges but include both individual patient level factors, as well as social and health care infrastructure barriers. One critical but potentially mutable factor associated with gaps in LTC, that has yet to be systematically evaluated for ED populations, is the role of patient's comprehension of the 'meaning' of patients' HCV diagnosis, which includes understanding the natural history of the disease, and the associated downstream health consequences of being infected. Placing HCV in the context of a patient based conceptual disease model provides a framework for studying knowledge gaps and misperceptions, which could be used to help improve patient engagement in care, and ultimately both clinical and public health outcomes. Leventhal's Common-Sense Model of Illness Representations provides a foundational framework for understanding an individual's belief and coping strategy to respond to his or her illness, with reliance on both concrete and abstract information (e.g. symptoms or acquired knowledge). For HCV, variables that may impact patient's engagement include a relative lack of urgency to receive care (due to the indolent nature of symptoms and often decades-long disease progression), a perception of ineffective treatment options (rooting from interferon therapy), and the perception of a relative low morbidity and mortality risk associated with HCV (versus e.g. HIV). Leveraging this Common-Sense Model theoretical framework, the investigators' research team proposes to design and evaluate the impact of a patient-centered HCV health belief conception framework for improving LTC interventions and the downstream HCV care continuum. Individualized risk information will be delivered in a patient-centric manner in the ED, gathering easily obtainable data that has proven to predict progression (i.e. Fibrosis-4 score). The investigators propose to first conduct a series of 3 focus group discussion sessions for participants to provide constructive comments and suggestions on the prototype of the personalized HCV educational app which has been blueprinted and is currently under development. This will be followed by development and pilot testing of a personalized patient-centered tablet-facilitated HCV educational program app, focusing on improving patient knowledge regarding HCV in real-time (including using and ED-based fibrosis staging service from precision medicine perspective). The patient informed staging service will include an estimated non-invasive Fibrosis-4 score; a serum fibrosis marker index (includes age, platelet count, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) values). The investigators hypothesize that providing individualized HCV disease progression staging information to ED patients, along with a structured educational LTC program to HCV-infected patients during patients' ED visit, will significantly change patient's health beliefs and perceptions of HCV, and motivate patients to achieve improved rates of LTC, retention in care, anti-viral treatment, and sustained virologic response along the HCV care cascade.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

308

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Deanna Myer
  • Número de teléfono: 443-287-6985
  • Correo electrónico: dmyer1@jhmi.edu

Copia de seguridad de contactos de estudio

  • Nombre: Tiana Jones
  • Número de teléfono: 410-735-6422
  • Correo electrónico: tpurrin1@jhmi.edu

Ubicaciones de estudio

    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Reclutamiento
        • Johns Hopkins University
        • Contacto:
          • Deanna Myer
          • Número de teléfono: 443-287-6985
          • Correo electrónico: dmyer1@jhmi.edu
        • Contacto:
          • Tiana Jones
          • Número de teléfono: 410-735-6422
          • Correo electrónico: tpurrin1@jhmi.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 100 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Johns Hopkins Hospital ED patient
  • 18 years or older
  • HCV positive without HCV RNA information

Exclusion Criteria:

  • Younger than 18 years of age
  • Unable to provide informed consent
  • Altered mental status
  • Incarcerated
  • Critically ill

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Patient-Centered Electronic App Group

Patients assigned to the intervention group will receive individualized reports regarding patients' HCV disease progress/liver fibrosis staging by a Fibrosis-4 score using the personalized HCV educational app. The individualized report will also include comprehensive knowledge to fill the gap on general HCV information, natural history of the disease, and care and treatment, if there is any, as well as level of interest in receiving HCV care based on patients' response to the short survey questionnaires on the tablet. Patients will also receive the investigators' HCV program pamphlet regarding HCV infection and disease progression, treatment, as well as information regarding clinics available for HCV care in Baltimore. Patients will receive standard of care, routine HCV LTC services from the investigators' ED HCV LTC program staff.

The coordinator will enter lab information to generate the patient's Fibrosis-4 score for liver fibrosis staging. With the information of liver fibrosis staging and survey responses, the app will generate individualized reports of the participant's comprehensive HCV disease progression, knowledge, and level of interest in receiving HCV care. The app will then deliver a streamlined, tailored, brief education message and include information regarding services and assistance for receiving HCV care.

Sin intervención: Reference Group

Patients assigned to the reference group will receive the investigators' current 'static' standard of care HCV program pamphlet regarding HCV infection and disease progression, treatment, as well as information regarding clinics available for HCV care in Baltimore City. Patients will also receive standard of care, routine HCV LTC services from the investigators' ED HCV LTC program staff.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Linkage to care rate (days)
Periodo de tiempo: 28 months

Linkage to care rate is defined as the time (days) between patient enrollment and the patient's first HCV-related clinic visit.

28 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in HCV knowledge as assessed by True/False survey questions
Periodo de tiempo: Immediately before and immediately after use of the education app, up to 1 hour

The survey uses True/False responses to twenty questions with scores ranging from 0 to 20. An increase in the patient's total number of correct answers indicates an increase in the patient's HCV knowledge.

Immediately before and immediately after use of the education app, up to 1 hour
Change in perceived barriers to HCV care as assessed by a Likert Scale
Periodo de tiempo: Immediately before and immediately after use of the education app, up to 1 hour

The survey uses a Likert Scale with 27 items; each item scored from 1 to 4. Overall score ranges between 27 and 108; a decrease in the patient's total score indicates a decrease in the patient's perceived barriers to HCV care.

Immediately before and immediately after use of the education app, up to 1 hour
Change in level of motivation to receive HCV care as assessed by a Likert Scale
Periodo de tiempo: Immediately before and immediately after use of the education app, up to 1 hour

The survey uses a Likert Scale with 27 items; each item scored from 1 to 4. Overall score ranges between 27 and 108; a decrease in the patient's total score indicates an increase in the patient's motivation to receive HCV care.

Immediately before and immediately after use of the education app, up to 1 hour
Number of patients who begin HCV antiviral treatment
Periodo de tiempo: 28 months

Number of patients who begin HCV antiviral treatment will be used to measure initiation of HCV antiviral treatment rate.

28 months
Number of patients who complete HCV antiviral treatment
Periodo de tiempo: 28 months

Number of patients who complete HCV antiviral treatment will be used to measure the completion of HCV antiviral treatment rate.

28 months
Number of patients who have an undetectable viral load 12 weeks after completing HCV antiviral treatment
Periodo de tiempo: 28 months

Number of patients who have an undetectable viral load 12 weeks after completing HCV antiviral treatment will be used to measure the sustained virologic response rate.

28 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Yu-Hsiang Hsieh, PhD, Johns Hopkins University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de marzo de 2022

Finalización primaria (Estimado)

1 de abril de 2027

Finalización del estudio (Estimado)

1 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

12 de noviembre de 2019

Primero enviado que cumplió con los criterios de control de calidad

12 de noviembre de 2019

Publicado por primera vez (Actual)

14 de noviembre de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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