- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07396064
Aproximar Distâncias: Melhorar o Cuidado Oncológico para Populações Carentes com a Plataforma Veris Health de Cuidados Oncológicos
Colmatar a Lacuna: Melhorar os Cuidados Oncológicos para Populações Carentes com a Plataforma Veris Health Cancer Care
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Brian deGuzman MD COO
- Número de telefone: 917-813-1828
- E-mail: bjd@verishealth.com
Locais de estudo
-
-
Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Recrutamento
- The Ohio State University
-
Contato:
- Raquel Reinbolt, MD
- Número de telefone: 614-293-8054
- E-mail: Raquel.Reinbolt@osumc.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Usability of the Veris Health Cancer Care Platform
Prazo: 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
|
|
Product Design Usability and Acceptability
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Health-Related Quality of Life (HRQL)
Prazo: 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
Prazo: 5 Months
|
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
Prazo: 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
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- VER-PR-0023
- 5R44MD019611-02 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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