跳至主要内容
临床试验/NCT04628039
NCT04628039已完成不适用

Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs (LAUREL Study)

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 622 人开始时间: 2021年5月27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
622
试验地点
2
主要终点
EuroQol 5 Dimension 5 Level (EQ-5D-5L) visual analog score

研究概览

简要总结

This is study is comprised of three approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, post-discharge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs.

详细描述

The long-term consequences of COVID 19 are not well understood, particularly in the Veteran population. This study will describe and quantify the long-term consequences of COVID-19, including impairment in physical and psychosocial function and health-related quality of life. Additionally, it will determine the impact of chronic lung disease (CLD) and other comorbidities on severity and recovery after COVID-19 infection and the association of social determinants of health with severity and recovery.

Initially, a retrospective national cohort of VA patients who test positive with SARS2 will be identified. Baseline clinical history will be analyzed with outcomes that include severity of COVID 19, all-cause mortality, and post-discharge events.

Subsequently, a mixed methods, prospective cohort study will include both qualitative (interview) and quantitative components (surveys). The investigators will identify patients with COVID-19 and recruited for qualitative interviews following hospital discharge or diagnosis. Patient caregivers will also be eligible to participate in study interviews. Interviews will occur once at various times ranging 2 weeks to 1 year since a patient's COVID-19 diagnosis. Surveys will be completed at 3 time points, 2-8 weeks after diagnosis or discharge to home, and then 6 months and 12 months later. Surveys will include the EQ-5D-5L profile for health-related quality of life, and the WHODAS 2.0 score for a global assessment of overall physical and psychosocial function. Investigators will also identify a comparator cohort of patients who have been diagnosed with lower respiratory tract infection (LRTI) in the setting of a negative COVID-19 test. Surveys will be administered at the same interval and analysis will determine if COVID-19 has different and more severe health impacts than other causes of lower respiratory tract infection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • (Patients in COVID-19 cohort) VA patients diagnosed with COVID-19 through a positive PCR (Polymerase Chain Reaction) or antigen SARS-CoV-2 test conducted in VA
  • (Caregivers) Providing caregiving to VA patients diagnosed with COVID-19
  • (Patients in LRTI cohort) VA patients diagnosed with LRTI and tested negative for COVID-19 (through PCR and/or antigen test)

排除标准

  • Cognitive limitations that preclude the ability to communicate and obtain informed consent
  • Language barriers

结局指标

主要结局

EuroQol 5 Dimension 5 Level (EQ-5D-5L) visual analog score

时间窗: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12

Profile for health-related quality of life. The investigators will summarize this measure with a visual analog score (VAS). The VAS ranges from 0 to 100mm (where 0="the worst health you can imagine"; 100="the best health you can imagine").

WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

时间窗: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12

Global assessment of overall physical and psychosocial function. The overall score for disability will be calculated using item-response-theory (IRT) based scoring. This scale ranges from 0 to 100 (where 0 = no disability; 100 = full disability).

EuroQol 5 Dimension 5 Level (EQ-5D-5L) overall utility index

时间窗: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12

Profile for health-related quality of life. We will summarize this measure with an overall utility index. The utility index ranges from less than 0 to 1(where \<0="worse than death";1=full health).

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 (2)

Loading locations...

相似试验