Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03474692 |
| Other study ID # |
2019-7 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 7, 2019 |
| Est. completion date |
October 2039 |
Study information
| Verified date |
December 2023 |
| Source |
Virta Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
