Setting up a Community Based Patient Cohort to Understand Long COVID: Monoclonal Antibody and Post-Infection COVID Vaccine Administration as the FOCI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been tested for COVID at one of the MultiCare facilities,
- •AND 18 years old or older at the viral test,
- •AND have no problem understanding English or Spanish.
排除标准
- •Pediatric patients younger than 18 years old at the time of testing,
- •OR patients who are pregnant,
- •OR patients who plan to get pregnant in 3 months,
- •OR patients who are hospitalized at the time of recruitment,
- •OR patients who have cognitive impairment(s) at the recruitment.
结局指标
主要结局
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.
时间窗: 18-month study length, with a pilot reliability study.
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.
次要结局
- Patients' COVID vaccination and mAb therapy history will be verified based on self report and EHR.(18-month study length)
- Selected comorbidities, all-cause hospitalization and ER visits.(3 months and 6 months follow-up.)