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

NCT04586413 · tracked via the Priya Life Science UK tracker

Sponsor

Medialis Ltd.

Phase

Observational

Started

2020-10-07

Last updated

2023-10-23

Condition(s) studied

Covid19

Investigational drug(s) / intervention(s)

No intervention - quality of life measure

No intervention - quality of life measure: Participants will be part of the creation of a Post-COVID-19 quality of life measure if involved in Phase One. In Phase Two participants will complete this post-COVID-19 quality of life measure monthly for 12 months

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Design of PAC19QoL Measure (Phase One) — 3 months
The design and creation of a Post-COVID-19 Quality of Life Measure
Completion of PAC19QoL Measure monthly for 12 months (Phase Two) — 12 months
Participants in Phase Two will complete the newly designed Post-COVID-19 quality of life measure each month for 12 months

Trial sites (1)

Facility	City	Region	Status
Medialis	Oxford	United Kingdom	Recruiting

More Medialis Ltd. trials in the UK

Global Overweight and oBesE (GLOBE) Patient Registry, Development and Implementation of Disease-specific: Severity, Quality of Life and Cost Instruments. Recruiting

Medical Affairs Pharmaceutical Physician Work-related Quality of Life (MAPPWrQoL) Instrument Development and Patient Registry (MAPPWrQoLReg) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04586413 on ClinicalTrials.gov ↗ ← All trials in the UK