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Virta Health Registry for Remote Care of Chronic Conditions

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ClinicalTrials.gov Identifier: NCT03474692
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Virta Health

Study Description
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Brief Summary:
The purpose of this registry is to establish a research data repository, comprised primarily of data generated in the course of clinical care, to conduct research on Virta Health clinical interventions and the chronic diseases suffered by Virta Health patients. This single-center repository that makes use of all clinical data generated through the provision of clinical services by Virta Health for its patients. Additional research-only patient follow-up information will also be collected via questionnaire.

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 primarily of data generated in the course of clinical care, to conduct research on Virta Health clinical interventions and the chronic diseases suffered by Virta Health patients. This single-center repository that makes use of all clinical data generated through the provision of clinical services by Virta Health for its patients. Additional research-only patient follow-up information will also be collected via questionnaire.

The scope of research under this protocol includes the following:

  1. Examining the efficacy, safety, and sustainability of Virta Health clinical interventions for treating chronic diseases and preventing associated adverse health outcomes.
  2. Examining the cost-effectiveness and economic impact of Virta Health clinical interventions for treating chronic diseases and preventing associated adverse health outcomes.
  3. Identifying demographics, clinical characteristics, co-morbidities, 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, co-morbidities, and adverse health outcomes associated with Virta Health clinical interventions.
  5. Characterizing typical presentation patterns, genetic determinants, biochemistry, and pathophysiology of the chronic diseases under treatment 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 or effectiveness data will be collected on devices; rather, research will focus only on the feasibility of adding the device to the treatment program 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
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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: Telemedicine Registry and Research Data Repository: The Virta Health Registry for Remote Care of Chronic Conditions
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : December 2067
Estimated Study Completion Date : December 19, 2067

Resource links provided by the National Library of Medicine


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Currently receiving, or has received in the past, clinical care from Virta Health
  3. Able to understand study procedures and willing to provide informed consent

Exclusion Criteria:

Contacts and Locations
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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


Contacts
Contact: Amy McKenzie, PhD 7654136171 amy@virtahealth.com

Locations
United States, California
Virta Health Recruiting
San Francisco, California, United States, 94105
Contact: Amy McKenzie    765-413-6171    amy@virtahealth.com   
Sponsors and Collaborators
Virta Health
More Information
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Responsible Party: Virta Health
ClinicalTrials.gov Identifier: NCT03474692     History of Changes
Other Study ID Numbers: 2017-3
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Chronic Disease
Disease Progression
 Multiple Chronic Conditions
Pathologic Processes
Disease Attributes