Post Acute COVID-19 Quality of Life (PAC-19QoL) Tool Development and Patient Registry (PAC-19QoLReg)
Recruiting now
Conditions studied: Covid19
In brief
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.
Key facts
- Study ID
- NCT04586413
- Run by
- Medialis Ltd.
- People needed
- 100
- Starts
- 2020-10-07
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2023-10-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medialis — Oxford, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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