Observational Pharmaco-Epidemiology Research & Analysis

NCT03813862 | Recruiting DMC

• 1 other identifier: Pro00023648
• Study Type: observational
• Target: 2,000,000
• Locations: 1 country
• Sites: 1

Brief Summary

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 evaluations of treatments of chronic diseases in the context of comorbid conditions and special populations (minorities, women, mentally ill, and those with addiction) are limited. The purpose of the OPERA database is to help address this unmet need in clinical research.

Conditions

Chronic Disease; HIV/AIDS; Liver Diseases; Inflammatory Bowel Diseases; Cardiovascular Diseases; Rheumatic Diseases; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (1)

• Virologic response to therapy

  HIV-1 PCR laboratory value ("viral load") quantifies the amount of HIV-1 copies in plasma per mL. The baseline viral load is compared to viral load after 1 year of antiretroviral therapy.

  1 year

Interventions

Non-interventional (observational only) OTHER

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patient population includes a diverse group of individuals treated in ambulatory practice with a focus on those living with chronic disease.

You may qualify if:

• 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

You may not qualify if:

• Patients who opt out of OPERA

Sponsors & Collaborators

• Epividian: lead

Study Sites (1)

Epividian

Durham, North Carolina, 27703, United States

RECRUITING

MeSH Terms

Conditions

Chronic Disease; Acquired Immunodeficiency Syndrome; Liver Diseases; Inflammatory Bowel Diseases; Cardiovascular Diseases; Rheumatic Diseases; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Digestive System Diseases; Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Nervous System Diseases

Central Study Contacts

Gregory Fusco, MD

CONTACT

224-632-1862; gregory.fusco@epividian.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 23, 2019
• Study Start: December 1, 2013
• Primary Completion (Estimated): November 1, 2035
• Study Completion (Estimated): November 1, 2035
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)