Health-related Quality of Life and Long COVID

NCT05552612 | Completed

• 1 other identifier: 2022-KEP-799
• Study Type: observational
• Target: 7,574
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Long COVID

Patients with Long COVID

Without Long COVID

Patients who do not have Long COVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who live in England

You may not qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• University of Oxford: collaborator

Study Sites (1)

London School of Hygiene and Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

Related Publications (1)

• Herrett E, Tomlin K, Lin LY, Tomlinson LA, Jit M, Briggs A, Marks M, Sandmann F, Parry J, Bates C, Morley J, Bacon S, Butler-Cole B, Mahalingasivam V, Dennison A, Smith D, Gabriel E, Mehrkar A, Goldacre B, Smeeth L, Eggo RMM. Protocol for an OpenSAFELY cohort study collecting patient-reported outcome measures using the TPP Airmid smartphone application and linked big data to quantify the health and economic costs of long COVID (OpenPROMPT). BMJ Open. 2023 Feb 17;13(2):e071261. doi: 10.1136/bmjopen-2022-071261.

  PMID: 36806073 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rosalind Eggo, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: September 26, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• 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.

Locations

GB (1)