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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

Locations
Other Locations
United Kingdom
Medialis
RECRUITING
Oxford
Contact Information
Primary
Omolade Femi-Ajao, PhD
research@medialis.co.uk
+447502228066
Backup
Ravi Jandhyala
ravi@medialis.co.uk
44(0)7717 448656
Time Frame
Start Date: 2020-10-07
Estimated Completion Date: 2028-10
Participants
Target number of participants: 100
Treatments
Non-hospitalised post-COVID-19 patients
This cohort will have had a confirmed positive test for COVID-19 or antibody test confirming they had COVID-19 but they were not hospitalised for this
Hospitalised post-COVID-19 patients
This cohort will have a confirmed diagnosis of COVID-19 and been hospitalised but were not in an Intensive Care Unit
Intensive care post-COVID-19 patients
This cohort will have a confirmed diagnosis of COVID-19 and been hospitalised in an Intensive Care Unit
Sponsors
Leads: Medialis Ltd.

This content was sourced from clinicaltrials.gov