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

NCT04586413 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-10-23

No results posted yet for this 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.

Conditions

  • Covid19

Interventions

OTHER

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

Sponsors & Collaborators

  • Medialis Ltd.

    lead INDUSTRY

Principal Investigators

  • Ravi Jandhyala · Medialis Ltd.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2028-10-31
Completion
2028-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04586413 on ClinicalTrials.gov