NCT04586413 Post Acute COVID-19 Quality of Life (PAC-19QoL) Tool Development and Patient Registry (PAC-19QoLReg)

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 100 participants in total. It began in 2020-10-07 with a primary completion date of 2028-10.

Brief Summary

Coronavirus Disease 2019 (COVID-19) is a newly emerged disease, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 pandemic is having a large impact on the mental and physical health of patients, yet data on the quality of life of post-COVID-19 patients is lacking. There are currently no post-COVID-19 specific measures for quality of life, particularly none which include the views of post-COVID-19 patients themselves. This observational study will recruit participants to contribute their preferences to the creation of a post-COVID-19 specific patient-reported measure on post-COVID-19 quality of life. Participants will be split into three groups: those who were not hospitalised; those who were hospitalised but not in intensive care units; and those who were hospitalised and in intensive care units. The creation of this measure will form phase 1 of the study, with 30-60 participants (10-20 in each group above) recruited to complete online surveys to find out their preferences of areas of life to include in such a measure. This will involve 3 online surveys, 1) to ask which areas of life they feel are impacted and how; 2) to find consensus about the areas to be included; 3) to weight the relevance of these areas in relation to each other. In phase 2 recruitment will open to additional participants and all participants will be asked to complete the finalised post-COVID-19 quality of life measure once a month for 12 months, aiming for a minimum of 100 participants at this stage. All participants will also be asked to complete a demographic questionnaire to inform the analysis of the data.

Eligibility Criteria

Phase One Inclusion Criteria: * The participant has had either a confirmed COVID-19 test while infected or a confirmed COVID-19 antibody test post-infection * The participant is aged 18 years or older * The participant is capable of providing informed consent * The participant can read, write and converse in English * The participant can comply with the study schedule Exclusion Criteria: * The participant does not have a confirmed COVID-19 test or antibody test * The participant is aged under 18 years * The participant is not capable of giving informed consent * The participant is unable to read, write and converse in English * The participant is unable to comply with study schedule data collection Phase Two Inclusion Criteria: * The participant has had either a confirmed COVID-19 test while infected or a confirmed COVID-19 antibody test post-infection or a clinical diagnosis of COVID-19 * The participant is aged 18 years or older * The participant is capable of providing informed consent * The participant can read, write and converse in English * The participant can comply with the study schedule Exclusion Criteria: * The participant does not have a confirmed COVID-19 test or antibody test or clinical diagnosis of COVID-19 * The participant is aged under 18 years * The participant is not capable of giving informed consent * The participant is unable to read, write and converse in English * The participant is unable to comply with study schedule data collection

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