- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07396064
Cerrando la Brecha: Mejorando la Atención Oncológica para Poblaciones Desatendidas con la Plataforma de Atención Oncológica Veris Health
The proposed study aims to optimize and validate the Veris Cancer Care Platform for the needs of medically underserved cancer patients receiving outpatient cancer therapy. The Veris Health platform is a remote patient monitoring and communication system designed to bridge the gap between clinical visits and provide oncology care teams with objective data during high-risk periods.
This study will specifically focus on optimizing the Veris Health platform for patients with language barriers, limited access to technology, and socioeconomic disparities. By incorporating user-centered design and working closely with community health centers, the research team will ensure that the platform is culturally and linguistically appropriate, easy to use, and accessible for all patients.
The study will use a mixed-methods approach to validate the effectiveness of the optimized platform, including quantitative data analysis and qualitative interviews with patients and healthcare providers. The goal is to demonstrate the potential for the Veris Health platform to improve outcomes for vulnerable populations by reducing hospitalizations, emergency department visits, and the economic burden of cancer care.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Brian deGuzman MD COO
- Número de teléfono: 917-813-1828
- Correo electrónico: bjd@verishealth.com
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Reclutamiento
- The Ohio State University
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Contacto:
- Raquel Reinbolt, MD
- Número de teléfono: 614-293-8054
- Correo electrónico: Raquel.Reinbolt@osumc.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Underserved population undergoing Cancer treatment with at least one on the following barriers to healthcare access: Spanish as primary language, uninsured, insured with Medicaid, dual eligible for Medicare and Medicaid.
Descripción
Inclusion Criteria:
- Adults > 18 years old
- Diagnosis of cancer
- ECOG Performance Status of 0-2
- Undergoing or initiating systemic anticancer therapy
- Able to utilize and interact with a mobile application and in-home devices for physiological monitoring. Have at least one of the following barriers to healthcare access: Spanish as primary language, uninsured, insured with Medicaid, dual eligible for Medicare and Medicaid
Exclusion Criteria:
-N/A
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Main Phase group
All participating subject utilizing the Veris Health app will complete all study health measurements with a 24 week period on the Veris Health app as well as participate in interviews and focus groups. |
Veris Health offers at-home devices to monitor multiple physiological parameters, including temperature, heart rate, oxygen saturation, blood pressure, weight, and activity (step count). Patients are provided with a home cellular hub that is already paired to peripheral devices via Bluetooth. The hub communicates with all devices and the local cellular network out-of-the-box, and data is automatically sent via cellular network to the Veris Health backend database, making it easy for patients to use the system. Patients are responsible for taking their vital sign measurements daily. The devices automatically send the measurement data to the Veris Health HIPAA compliant, secure cloud server via the preconnected cellular hub. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Usability of the Veris Health Cancer Care Platform
Periodo de tiempo: 5 Months
|
Usability of the Veris Health Cancer Care platform as assessed by the Software Usability Measurement Inventory (SUMI) among patients, caretakers, and healthcare teams. Measure: SUMI total and domain scores Time Frame: During study participation |
5 Months
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Product Design Usability and Acceptability
Periodo de tiempo: 5 Months
|
Ease of use, accessibility, and acceptability of the Veris Health Cancer Care platform based on A/B testing of product design features. Measure: Comparative usability metrics (e.g., task completion success, user preference) Time Frame: During study participation |
5 Months
|
|
User Needs and Preferences
Periodo de tiempo: 5 Months
|
User-identified needs, preferences, and barriers to use of the Veris Health Cancer Care platform. Measure: Qualitative themes derived from user interviews and focus groups Time Frame: During study participation |
5 Months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Health-Related Quality of Life (HRQL)
Periodo de tiempo: 5 Months
|
Change in health-related quality of life among participants using the Veris Health Cancer Care platform. Measure: EQ-5D Index score |
5 Months
|
|
Symptom Burden of Cancer Treatment Side Effects
Periodo de tiempo: 5 Months
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Frequency and severity of cancer treatment-related symptoms, including nausea, diarrhea, and infection. Measure: Patient-reported symptom frequency and severity scores |
5 Months
|
|
Cancer Treatment Adherence and Duration
Periodo de tiempo: 5 months
|
Adherence to prescribed cancer therapy and treatment duration. Measure: Rates of dose reductions, early treatment discontinuation, and treatment duration |
5 months
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- VER-PR-0023
- 5R44MD019611-02 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .