De kloof overbruggen: Kankerzorg verbeteren voor onderbediende bevolkingsgroepen met het Veris Health Cancer Care Platform
De kloof overbruggen: Kankerzorg verbeteren voor onderbedeelde bevolkingsgroepen met het Veris Health Cancer Care Platform
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Brian deGuzman MD COO
- Telefoonnummer: 917-813-1828
- E-mail: bjd@verishealth.com
Studie Locaties
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Ohio
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Columbus, Ohio, Verenigde Staten, 43210
- Werving
- The Ohio State University
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Contact:
- Raquel Reinbolt, MD
- Telefoonnummer: 614-293-8054
- E-mail: Raquel.Reinbolt@osumc.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Usability of the Veris Health Cancer Care Platform
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Health-Related Quality of Life (HRQL)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 5 months
|
Adherence to prescribed cancer therapy and treatment duration. Measure: Rates of dose reductions, early treatment discontinuation, and treatment duration |
5 months
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- VER-PR-0023
- 5R44MD019611-02 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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