Clincosm LogoSign in Get a demo

Virta Health Registry

Sponsor
Virta Health (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03474692
Collaborator
(none)
50,000
Enrollment
1
Location
239.8
Anticipated Duration (Months)
208.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    The Virta Health Registry for Remote Care of Chronic Conditions
    Actual Study Start Date :
    Oct 7, 2019
    Anticipated Primary Completion Date :
    Oct 1, 2039
    Anticipated Study Completion Date :
    Oct 1, 2039

    Outcome Measures

    Primary Outcome Measures

    1. Change in Chronic Disease Status [6+ months]

      change in disease status or markers of disease status over time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Virta Health Patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virta Health San Francisco California United States 94105

    Sponsors and Collaborators

    • Virta Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virta Health
    ClinicalTrials.gov Identifier:
    NCT03474692
    Other Study ID Numbers:
    • 2019-7
    First Posted:
    Mar 22, 2018
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Disease
    Disease Progression
    Chronic Disease
    Multiple Chronic Conditions

    Study Results

    No Results Posted as of May 2, 2022