Health-related Quality of Life and Long COVID

NCT ID: NCT05552612

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7574 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-26

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Long COVID

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Long COVID

Patients with Long COVID

No interventions assigned to this group

Without Long COVID

Patients who do not have Long COVID

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oxford

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Emily Herrett

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rosalind Eggo, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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London School of Hygiene and Tropical Medicine

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 36806073 (View on PubMed)

Other Identifiers

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2022-KEP-799

Identifier Type: -

Identifier Source: org_study_id

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