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Virta Health Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474692
Recruitment Status : Active, not recruiting
First Posted : March 22, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Virta Health

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
Multiple Chronic Conditions Chronic Disease Disease Progression Long-Term Care Telemedicine

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.

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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in Chronic Disease Status [ Time Frame: 1+ years ]
    change in disease status or markers of disease status over time



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria
Virta Health Patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474692


Locations
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United States, California
Virta Health
San Francisco, California, United States, 94105
Sponsors and Collaborators
Virta Health

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Responsible Party: Virta Health
ClinicalTrials.gov Identifier: NCT03474692    
Other Study ID Numbers: 2019-7
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Disease Progression
Chronic Disease
Multiple Chronic Conditions
Pathologic Processes
Disease Attributes