跳至主要内容
临床试验/NCT05394025
NCT05394025已完成不适用

COVID-19 Observational Research Collaboratory - Long-Term Outcomes (LTO) Study

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 479 人开始时间: 2022年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
479
试验地点
6
主要终点
Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score

研究概览

简要总结

This study aims to examine the long-term outcomes in Veterans infected and uninfected with SARS-CoV-2 using electronic health record information and structured surveys.

详细描述

Background: Early evidence suggests that the frequency and type of long term complications stemming from SARS-CoV-2 infection may depend on the severity of initial presentation. However, additional unidentified factors may also play a role including those related to the individual, the environment and/or the specific strain of the virus. The long-term health impacts of SARS-CoV-2 will have major implications for health care utilization, care processes and quality and costs of care for Veterans, both within the VA and in the community. Over 200,000 Veterans have had COVID-19. Although the long term consequences of this novel illness are unknown, it is clear they will often be significant. The overarching goal in the Long-Term Outcome Study (LTO) is to advance VA HSR&D research into the consequences and care of COVID-19 infection by developing and releasing integrated multi-modal data and results on long-term outcomes of COVID for use by VA clinical, research and operations communities. The investigators will do so via a coordinated program of data production and analysis using the VA electronic health record (EHR) and other administrative sources (e.g., Medicare), de novo longitudinal survey, and qualitative inquiry. This work will be closely coordinated with the COVID-19 Observational Research Collaboratory (CORC) Coordinating Center (CCC) and the burgeoning community of HSR&D-funded COVID researchers.

This study aims to examine the long-term outcomes in Veterans infected and uninfected with SARS-CoV-2.

Aim 1: Using VINCI-CDW data, patients will be identified who had a SARS-CoV-2 test since February 2020. The investigators will use a combination of traditional epidemiologic studies, and machine learning algorithms to determine the long term, multi-systemic and functional adverse outcomes and/or syndromes related to SARS-CoV-2. Members of the research team are currently developing methods to identify new onset and exacerbations in comorbidities following SARS-CoV-2 illness in Veterans.

Aim 2: Determine Veteran-Reported Outcome Effects Using Structured Survey on domains such as self- reported symptoms, disability, and financial impacts, measured repeatedly over 36 months.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All VA enrollees since February 2020, which includes all patients who were tested for SARS-CoV-2 and are included in the VA COVID-19 Shared Data Resource in CDW.

排除标准

  • VA employees

结局指标

主要结局

Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score

时间窗: Survey months 18, 24, 30, 36

Measures level of disability on a scale from 0 - 14, where higher values are considered a worse outcome. Multiple survey timepoints will allow us to assess change in disability over time. The score consists of 14 questions about activities of daily living. The I/ADL score is a sum total of reported limitations ranging from 0 (no limitations reported) to 14 (limitations in all activities asked reported).

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

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