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

NCT04586413 | Recruiting

• 1 other identifier: Med_Asst 33
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Covid19; Quality of Life; Post-Covid19

Outcome Measures

Primary Outcomes (2)

• Design of PAC19QoL Measure (Phase One)

  The design and creation of a Post-COVID-19 Quality of Life Measure

  3 months

• Completion of PAC19QoL Measure monthly for 12 months (Phase Two)

  Participants in Phase Two will complete the newly designed Post-COVID-19 quality of life measure each month for 12 months

  12 months

Study Arms (3)

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

Other: No intervention - quality of life measure

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

Other: No intervention - quality of life measure

Intensive care post-COVID-19 patients

This cohort will have a confirmed diagnosis of COVID-19 and been hospitalised in an Intensive Care Unit

Other: No intervention - quality of life measure

Interventions

No intervention - quality of life measure OTHER

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

Hospitalised post-COVID-19 patients; Intensive care post-COVID-19 patients; Non-hospitalised post-COVID-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will have a confirmed diagnosis of COVID-19 from either a test while infected or an antibody test post infection for Phase One. Participants in Phase Two will have either confirmed test/antibody test or clinical diagnosis of COVID-19

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
• 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
• 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

Sponsors & Collaborators

• Medialis Ltd.: lead

Study Sites (1)

Medialis

Oxford, OX16 0AH, United Kingdom

RECRUITING

Related Publications (1)

• Jandhyala R. Design, validation and implementation of the post-acute (long) COVID-19 quality of life (PAC-19QoL) instrument. Health Qual Life Outcomes. 2021 Sep 28;19(1):229. doi: 10.1186/s12955-021-01862-1.

  PMID: 34583690 DERIVED

Related Links

• Publication
• Related Info

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ravi Jandhyala

  Medialis Ltd.

  STUDY CHAIR

Central Study Contacts

Omolade Femi-Ajao, PhD

CONTACT

+447502228066; research@medialis.co.uk

Ravi Jandhyala

CONTACT

44(0)7717 448656; ravi@medialis.co.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: October 7, 2020
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)