Observational Pharmaco-Epidemiology Research & Analysis
Observational · No treatment assigned · 1 site · Epividian
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Chronic Disease, HIV/AIDS and Liver Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 0 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Patients who are treated in the practices who enroll and participate in the study
- Patients whose treatment is documented in the practice's electronic health record system
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 2000000 participants are expected to take part.
- Start date: 2013-12-01.
- Main results expected around 2035-11 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Virologic response to therapy (1 year)
In the researchers’ words
Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical Decision Support Systems that complement the EHR use in support of routine patient care, population management and disease management; and 2) the use of the point-of-care observational data from the provider-patient encounter that support realworld medical research and healthcare quality measure assessment. Real-world…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Chronic Disease; HIV/AIDS; Liver Diseases; Inflammatory Bowel Diseases; Cardiovascular Diseases; Rheumatic Diseases; Neurodegenerative Diseases |
| Lead sponsor | Epividian |
| Enrollment | 2000000 (estimated) |
| Start date | 2013-12-01 |
| Primary completion (est.) | 2035-11 |
| First posted | 2019-01-23 |
| Last updated | 2026-09-11 |
| Official title | OPERA Longitudinal Observational Database in the Study of Chronic Diseases, Treatments and Outcomes |
| ClinicalTrials.gov ID | NCT03813862 |
Interventions
- Non-interventional (observational only) (Other)
Full eligibility criteria (from the record)
Inclusion Criteria: * Patients who are treated in the practices who enroll and participate in the study * Patients whose treatment is documented in the practice's electronic health record system Exclusion Criteria: * Patients who opt out of OPERA
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Epividian | Durham, North Carolina | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.