Cardiovascular Diseases, Covid19, ME/CFS, Neurocognitive Disorders, Novel Coronavirus Infection, SARS COV2
Conditions
Brief summary
The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) study is a CDC-funded COVID-19 project to understand the long-term health outcomes in recently tested adults, both negative and positive, who have suspected COVID symptoms at the time of their test. Participants will complete short online surveys every 3 months for 18 months, share information about their health using a secure web-based platform, and are compensated for their time.
Detailed description
This study will use a digital platform to longitudinally track comprehensive information including patient self-report as well as data that describe the process and outcome of care in the electronic medical record (EMR) of a large representative sample of patients under investigation for SARSCOV2. The objective is to generate knowledge rapidly using digital tools and collaborative sciences to produce real-time data, analysis, and reporting compared to more traditional approaches. An additional goal is to promote an open science approach whereby scientists, with proper approvals and in line with the permissions granted by the participants, have the opportunity to work with data in ways that protect individual privacy but promote rapid dissemination and implementation of knowledge.
Interventions
None listed
Sponsors
Yale University
University of Washington
Thomas Jefferson University
University of California, Los Angeles
University of California, San Francisco
University of Texas Southwestern Medical Center
The University of Texas Health Science Center, Houston
Rush University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Fluent in English or Spanish; 2. Age 18 and over; 3. Self-reported symptoms suggestive of acute SARSCOV2 infection; 4. Under investigation for SARSCOV2 (defined as a patient who has received any screening or diagnostic test used to detect the presence of COVID19 including any FDA approved or authorized molecular or antigen-based assay) within the last 42 days.
Exclusion criteria
1. Unable to provide informed consent; 2. Study team unable to confirm result of diagnostic test for SARSCOV2; 3. Does not have access to a hand-held device or computer that would allow for digital participation in the study; 4. Individuals who are prisoners while participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess for medium and long-term sequalae of SARS-CoV-2 infection | 18 months post enrollment | Clinical phenotypes of sequelae will be determined at the time of analysis based on published literature |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory care and/or ED visits post enrollment | 18 months post enrollment | Count of ambulatory care and/or ED visits post enrollment as obtained from the EMR |
| Hospitalizations post enrollment | 18 months post enrollment | Count of hospitalizations post enrollment as obtained from the EMR |
| Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) | 18 months post enrollment | Determine the risk of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in those with symptoms of SARSCOV2 infection with vs. without a positive confirmatory test. |
| Hospital-free survival | 18 months post enrollment | Hospital-free survival as determined by data from the EMR |
| ICU-free survival | 18 months post enrollment | ICU-free survival as determined by data from the EMR |
| Death during hospital admission | 18 months post enrollment | Death during hospital admission as determined by data from the EMR |
Countries
United States
Outcome results
None listed