Health-related Quality of Life and Long COVID (OpenPROMPT)

Quality-of-life in Patients With Long COVID: Harnessing the Scale of Big Data to Quantify the Health and Economic Costs

Background: Long COVID is estimated to affect 1.7 million people in the UK. One way of assessing the impact of long COVID is to measure quality-of-life through a standard questionnaire, which can then be used to understand the costs of long COVID to the NHS and wider economy. The impact of long COVID on these measures is not currently known. It is important to understand who is worst affected by long COVID and the cost to the National Health Service (NHS), so that strategies like booster vaccines can be prioritised to the right people.

Aim: OpenPROMPT aims to understand the impact of long COVID on quality-of-life in adults in English primary care.

Methods: We will ask people to participate in the study by downloading a smartphone app, and completing a series of questionnaires held within the app. Questionnaires will ask about quality of life, productivity and symptoms of long COVID. Participants will be asked to fill in the questionnaires once a month, for four months. Electronic reminders will be sent to participants to ask them to complete the questionnaires, which will take roughly 15 minutes to complete each month. Participants will also be asked to give consent for linkage of their questionnaire responses to their existing health records.

The results will tell us if long COVID has different quality-of-life and economic impacts among people of different ages, ethnicities, geographic regions, or because of any underlying health conditions. These results can be converted into standardised measurements used by the NHS to measure the impact of illnesses and the cost of long COVID to health services.

Impact: Together with other researchers studying long COVID, we will provide results to support long-term care, and make recommendations for prevention of long COVID in the future. At all stages we will ensure that the input of patients and the public is central to running the study and interpreting the outputs.

Funding: OpenPROMPT is a collaboration between the London School of Hygiene and Tropical Medicine, the OpenSAFELY patient data platform at the University of Oxford, and TPP (which supplies clinical software to General Practices (GPs) in the UK). The project is funded by the National Institute for Health Research.

Study Overview

• Status: Completed
• Conditions: Long COVID

• Study Type: Observational
• Enrollment (Actual): 7574

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1E 7HT
    • London School of Hygiene and Tropical Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

People who live in England

Description

Inclusion Criteria:

• Inclusion criteria are that the patient is aged 18 or over and can read and understand English, and can download and use the Airmid app.

Exclusion Criteria:

• The following patients will be excluded:
• Patients under 18 years old;
• Patients who do not have a smartphone or cannot download or log in to the Airmid app;
• Patients who cannot understand English.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Long COVID; Patients with Long COVID
Without Long COVID; Patients who do not have Long COVID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	Measured using the EQ-5D-5L score (EuroQoL score across 5 dimensions and 5 levels). EQ-5D-5L is measured on a scale between 0 and 1, where 0 is a state as bad as being dead, and 1 is full health.	day 0

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: University of Oxford
• Investigators: Principal Investigator: Rosalind Eggo, PhD, London School of Hygiene and Tropical Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2022-KEP-799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The questionnaire data provided by participants will be made available to allow other researchers to benefit from this work in the future, and for a range of different studies and purposes. Opting-in to the study will require an affirmative response to agree to use of data in this way.

After completion of the study, a pseudonymised copy of the data will be held according to NHS England retention policy, https://www.england.nhs.uk/contact-us/privacy-notice/how-we-use-your-information/covid-19-response/coronavirus-covid-19-research-platform/. Data access will be governed by London School of Hygiene and Tropical Medicine (LSHTM, data controller) and will require researchers to complete a data access form. This will be explained in all publications arising from the study.

IPD Sharing Time Frame

The study protocol and informed consent form will be published in a study protocol paper in a peer reviewed medical journal.

Analytic code will be shared as part of OpenSAFELY standards.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No