Development of a quality of life tool for post-COVID-19 patients
Post Acute COVID-19 Quality of Life (PAC-19QoL) Tool Development and Patient Registry (PAC-19QoLReg)
This study is trying to create a new tool to measure how COVID-19 affects the quality of life for people recovering from the virus, including those who were hospitalized and those who weren't.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medialis Ltd. Industry-sponsored |
| Locations | 1 site (Oxford) |
| Trial ID | NCT04586413 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a specific quality of life measure for individuals recovering from COVID-19. Participants will be recruited and divided into three groups based on their hospitalization status: not hospitalized, hospitalized but not in intensive care, and hospitalized in intensive care. The study will utilize a novel method to gather insights from participants about the areas of their lives affected by COVID-19, which will inform the creation of the quality of life tool. Following the development phase, participants will be invited to complete the tool monthly for a year to assess its effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have had a confirmed COVID-19 infection or antibody test.
Not a fit: Patients who have not been diagnosed with COVID-19 or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a tailored quality of life measure that better reflects the experiences of post-COVID-19 patients.
How similar studies have performed: While there have been studies on quality of life in COVID-19 patients, the specific approach of developing a patient-reported measure based on direct input from patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oxford
- Medialis — Oxford, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Omolade Femi-Ajao, PhD
- Email: research@medialis.co.uk
- Phone: +447502228066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.