Virta Health Registry

The Virta Health Registry for Remote Care of Chronic Conditions

The purpose of this registry is to establish a research data repository, comprised of data generated in the course of providing clinical services to patients treated by Virta Health, to conduct secondary research on clinical interventions and chronic diseases.

Study Overview

• Status: Active, not recruiting
• Conditions: Disease Progression; Chronic Disease; Telemedicine; Multiple Chronic Conditions; Long-Term Care

Detailed Description

The purpose of this registry is to establish a research data repository, comprised of data generated in the course of providing clinical services to patients treated by Virta Health, to conduct secondary research on clinical interventions and chronic diseases.

The scope of research under this protocol includes the following:

1. Examining the effectiveness, safety, and sustainability of Virta Health clinical interventions for treating chronic diseases and prevention of or regression of associated adverse health outcomes.
2. Examining the cost-effectiveness and economic impact of Virta Health clinical interventions for treating chronic diseases and preventing or regressing associated adverse health outcomes.
3. Identifying demographics, clinical characteristics, comorbidities, concomitant treatments, genetic variants, and behavioral phenotypes that predict more or less favorable clinical outcomes of subjects to Virta Health clinical interventions for chronic diseases.
4. Examining the impact of mental health and the behavioral modification components of Virta Health clinical interventions on disease markers, comorbidities, and adverse health outcomes associated with Virta Health clinical interventions.
5. Characterizing typical presentation patterns, genetic determinants, biochemistry, and pathophysiology of the chronic diseases treated by Virta Health.
6. Exploring relationships between dietary composition and physiologic characteristics of chronic diseases.
7. Exploring the interrelationship and common clinical/biological features of the various chronic diseases under treatment by Virta Health.
8. Compiling case reports and case series of interesting disease presentations and outcomes, of the chronic diseases Virta Health treats, that may inform about the disease state and treatment responses.
9. Validating the integration of technological aids into Virta Health clinical interventions. Where the impacts of devices are examined, devices will be FDA-approved and approved, marketed devices. No safety data will be collected on devices; rather, research will focus only on the feasibility of adding the device to the treatment program, its relationship with participant behaviors and health outcomes, and patient satisfaction attributable to the device.
10. Understanding the relationships of patient needs, educational methods, and use of the Virta Health online Application, to subsequent patient satisfaction/clinical outcomes.

• Study Type: Observational
• Enrollment (Estimated): 50000

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80216
      • Virta Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients receiving medical care from Virta Health for their chronic condition, most commonly type 2 diabetes, prediabetes, and metabolic syndrome.

Description

Virta Health Patients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Chronic Disease Status	change in disease status or markers of disease status over time	6+ months

Collaborators and Investigators

• Sponsor: Virta Health

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Estimated): October 1, 2039
• Study Completion (Estimated): October 1, 2039

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 23, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Disease; Chronic Disease; Multiple Chronic Conditions
• Other Study ID Numbers: 2019-7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No