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

RECRUITING

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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.

Conditions:

🦠 COVID-19

🗓️ Study Start (Actual) 31 January 2022

🗓️ Primary Completion (Estimated) 15 March 2026

✅ Study Completion (Estimated) 15 March 2026

👥 Enrollment (Estimated) 999

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Woonsocket, Rhode Island, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 15 December 2021
First Submitted that Met QC Criteria 15 December 2021
First Posted 16 December 2021

Study Record Updates

Last Update Submitted that Met QC Criteria 24 May 2024
Last Update Posted 28 May 2024
Last Verified May 2024