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This study will be observational only. It will provide real-world evidence generated from a representative and large-scale COVID patient base. The adoption, pilot testing and use of NIH PROs among viral tested patients with research purpose on long COVID will be unique and innovative. With the existing and proven scientific rigor, NIH PRO system will be adopted, then modified and tailored to form the long hauler specific, comprehensive instrument, helping generalize future knowledge regarding COVID-infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID positive case with mAb treatment | |||
| COVID positive case having not received mAb treatment | |||
| COVID negative cases |
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| Measure | Description | Time Frame |
|---|---|---|
| Adopt the NIH PROMIS system (The Assessment Center Instrument Library, which includes all Fixed Length Short Form and Computer Adaptive Test/Item Bank instruments from PROMIS) to construct a modified comprehensive PRO instrument. | Using a modified NIH PRO measurement system. This system will involve different domains and instruments. Patients will answer PRO questions at the time of recruitment (baseline), then followed up 3 months and 6 months after the first survey (follow-up). The modified comprehensive PRO instrument will specifically ask patients to report symptoms based on their health status within a fixed time window, and at the time when the survey questions are given. | 18-month study length, with a pilot reliability study. |
| Measure | Description | Time Frame |
|---|---|---|
| Selected comorbidities, all-cause hospitalization and ER visits. | Extracted from patients' electronic health records. | 3 months and 6 months follow-up. |
| Patients' COVID vaccination and mAb therapy history will be verified based on self report and EHR. |
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Inclusion Criteria:
Exclusion Criteria:
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A small representative sample of up to 50 patients (25 hospitalized and alive at the time of the extraction) will be randomly selected and invited to test for the PRO instrument
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hollis Zeng | Contact | 2534037250 | hzeng38@emory.edu | |
| Jin Mou | Contact | 2534037250 | jin.mou@multicare.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MultiCare Health System | Recruiting | Tacoma | Washington | 98405 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 18-month study length |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |