Virta Health Registry for Remote Care of Chronic Conditions
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03474692|
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
|Condition or disease|
|Multiple Chronic Conditions Chronic Disease Disease Progression Long-Term Care Telemedicine|
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:
- Examining the efficacy, safety, and sustainability of Virta Health clinical interventions for treating chronic diseases and preventing associated adverse health outcomes.
- Examining the cost-effectiveness and economic impact of Virta Health clinical interventions for treating chronic diseases and preventing associated adverse health outcomes.
- 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.
- 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.
- Characterizing typical presentation patterns, genetic determinants, biochemistry, and pathophysiology of the chronic diseases under treatment by Virta Health.
- Exploring relationships between dietary composition and physiologic characteristics of chronic diseases.
- Exploring the interrelationship and common clinical/biological features of the various chronic diseases under treatment by Virta Health.
- 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.
- 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.
- 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 [Patient Registry]|
|Estimated Enrollment :||50000 participants|
|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|
- Change in Chronic Disease Status [ Time Frame: 1+ years ]change in disease status or markers of disease status over time
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
|Contact: Amy McKenzie, PhDemail@example.com|
|United States, California|
|San Francisco, California, United States, 94105|
|Contact: Amy McKenzie 765-413-6171 firstname.lastname@example.org|