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

October 19, 2023 updated by: Medialis Ltd.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This observational study will be conducted in two phases:

Phase 1 - the development of a post-COVID-19 patient reported quality of life measure Phase 2 - the longitudinal completion of the quality of life tool by post-COVID-19 patients each month for 12 months All participants will complete an online informed consent form and a demographic questionnaire at the start of their involvement with the study Phase 1 The study will recruit a minimum of 30 participants and a maximum of 60 participants, 10-20 across 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. Investigators will take the first 10-20 participants who match in each group. If contact is received from participants but their group is already full they will be asked if they are still be happy to participate in phase 2 and an offer to contact them when that commences will be made.

Firstly, a novel method (Jandhyala Method) will be used to elicit post-COVID-19 patients' preferences for a post-COVID-19 quality of life tool. Participants will do this by completing an Awareness Round survey, this means using free-text responses to ask participants about the areas of their lives impacted by COVID-19 and those areas they see as most important to their quality of life. The research team will collate and code these free text responses then create a comprehensive list of all of those deemed important to participants who will then be sent a Consensus Round survey to ask how far they agree or disagree with the inclusion of those items in a quality of life tool. Researchers will then collate this information, group it into relevant domains and develop a weighting tool to be sent to participants to ask them to rate the relevant importance of the different areas to be included, which will be used to create weighted domain and item scores to be used in a final quality of life tool. We expect for the Awareness round surveys to be completed within a one month time period and then two weeks will be allocated for the research team to analyse and finalise the Consensus round survey; the Consensus round survey will then be open for two weeks, with prompting to participants after one week if not completed. The research team will then have a further two weeks to complete the weighting tool and participants will be given a further two weeks to complete this. At this stage the research team will have a further two weeks to finalise the Post-COVID-19 quality of life tool and then phase 2 will begin.

In summary:

  1. Awareness round online survey (hosted on Survey Monkey) - asking for areas of life which the participants feel have been impacted by COVID-19, including details and examples of those impacts

    a. The research team will collate and code these responses and generate a list of statements based on the information provided by participants

  2. Consensus round online survey (hosted on Survey Monkey) - the list of statements will be sent to participants and they will be asked to rate how far they agree or disagree with the inclusion of these areas in a post-COVID-19 quality of life tool

    a. The research team will collate this information, group it into relevant domains and develop a weighting tool

  3. Weighting tool (online Microsoft excel template) - participants will be asked to weight the individual items and domains for the finalised post-COVID-19 quality of life tool using an online excel spreadsheet template a. The research team will use this information to develop the finalised post-COVID-19 quality of life measure to be completed by participants and to develop the system to score this tool Phase 2 At this stage the recruitment will be re-opened for additional participants, including those with a clinical diagnosis regardless of test status, aiming for a minimum of 100 and a maximum of 5000 at this stage, though this will be subject to review. Recruitment will remain open for time 1 surveys for one year, with a another year following this to gain the full 12 months of data from participants, again subject to review. The finalised post-COVID-19 quality of life measure will be hosted on a secure online system (Castor EDC tm) and participants will be allocated an ID number. They will be asked to complete this measure at monthly intervals for a period of 12 months. The research team will analyse the changes over time within and between groups. Statistical methods for this will be finalised when the measure has been completed at the end of Phase 1 by our biostatistician.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Design of PAC19QoL Measure (Phase One)
Time Frame: 3 months
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)
Time Frame: 12 months
Participants in Phase Two will complete the newly designed Post-COVID-19 quality of life measure each month for 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medialis Ltd.

Investigators

  • Study Chair: Ravi Jandhyala, Medialis Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Med_Asst 33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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