Patient Reported Health-Related Quality of Life Associated With COVID-19

Recruiting

Brief Summary: COVID-19 pandemic elicited broad medical, economic, and social consequences. There is limited research and outstanding data gaps related to understanding the impact of long-term effect of COVID-19 on Health-Related Quality of Life (HRQoL) and Work Productivity and Activity Impairment (WPAI) in the outpatient settings in the US.

Information on the evolution of recovery of daily function and the return to the level of health enjoyed by outpatients prior to SARS-CoV-2 infection will inform the overall estimation of the benefits of vaccines (quality-adjusted life years \[QALYs\] and indirect cost saving) in COVID-19 health economics models.

Detailed Description: This is a non-interventional (NI) prospective longitudinal participant reported outcome (PRO) study on adults who consented to participate in the PRO study on HRQoL and WPAI. To be eligible for the enrollment, participants would have at least one self-reported ARI symptom and RT-PCR test positive confirmation.

Recruitment & Eligibility

Inclusion Criteria

Age 18 or older
Self-reported at least one symptom in the CVS Health pre-test screening questionnaire
Positive result reported from the laboratory using RT-PCR test method
Evidence of a signed and dated informed consent through electronic consent process indicating that the participant has been informed of all pertinent aspects of the study
Able to complete the questionnaires by themselves in English or Spanish

Exclusion Criteria

No symptom reported in the CVSH pre-test questionnaire
COVID-19 test is done with non-RT-PCR methods such as a rapid antigen test or antibody test

Arm && Interventions

Group	Intervention	Description
COVID-19 Positive	COVID-19 Vaccine	Test-confirmed COVID-19 illness and at least one patient-reported symptom

Primary Outcome Measures

Name	Time	Method
Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L	6 months	To assess the change in HRQoL using EQ-5D-5L before COVID-19 or influenza and over a 6-month period following the test-confirmed COVID-19 or influenza.
EQ-5D-5L Utility Index (UI) scores	6 months	To estimate the EQ-5D-5L UI scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.
Visual Analog Scale (VAS) scores	6 months	To estimate the VAS scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.
WPAI scores	6 months	To estimate the WPAI scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.

Secondary Outcome Measures

Name	Time	Method
Prevalence and duration of SARS-CoV-2 symptoms	6 months	To characterize prevalence and duration of SARS-CoV-2 symptoms before COVID-19 and up to 6 months (acute phase and Long COVID).
Prevalence, Severity, and duration of influenza symptoms aggregated as index score area under the curve	6 Months	To characterize prevalence and duration of influenza symptoms before influenza and up to 6 months (acute phase and Long Flu). Outcome will be aggregated by assigning a point-scale to the symptom severity and calculating the area under the curve of the severity index score.
Fatigue before COVID-19	6 months	To assess fatigue (using PROMIS questionnaire Fatigue short-form 8a) before COVID-19 and over a six-month follow-up.
Fatigue after COVID-19	6 months	To estimate the PROMIS questionnaire Fatigue short-form 8a score and its change across six time points in a span of six months following the RT-PCR confirmed COVID-19.

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