- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07396064
Bridging the Gap: Enhancing Cancer Care for Underserved Populations With the 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Brian deGuzman MD COO
- Phone Number: 917-813-1828
- Email: bjd@verishealth.com
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
Contact:
- Raquel Reinbolt MD
- Phone Number: 614-293-8054
- Email: Raquel.Reinbolt@osumc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usability of the Veris Health Cancer Care Platform
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-Related Quality of Life (HRQL)
Time Frame: 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
Time Frame: 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
Time Frame: 5 months
|
Adherence to prescribed cancer therapy and treatment duration. Measure: Rates of dose reductions, early treatment discontinuation, and treatment duration |
5 months
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VER-PR-0023
- 5R44MD019611-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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