Covid19 Clinical Trial - Health-related Quality of Life & Long COVID

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Long COVID

Clinical Trial Details

NCT number	NCT05552612
Study type	Observational
Source	London School of Hygiene and Tropical Medicine
Contact
Status	Completed
Phase
Start date	September 26, 2022
Completion date	December 31, 2023

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Health-related Quality of Life and Long COVID — OpenPROMPT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms