Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-05 @ 6:12 PM
Study NCT ID:
NCT03474692
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2018-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virta Health Registry
Sponsor:
Virta Health
Organization:
Study Overview
Official Title:
The Virta Health Registry for Remote Care of Chronic Conditions
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: