Long COVIDOpenPROMPTNCT05552612
Health-related Quality of Life and Long COVID
An observational study of Long COVID, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long COVID
- How many people
- 7,574 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Sep 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People who live in England
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Hygiene and Tropical Medicine
London, WC1E 7HT
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Long COVID | Patients with Long COVID | |
| Without Long COVID | Patients who do not have Long COVID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start26 Sep 2022
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,574 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Principal investigator, Emily Herrett, London School of Hygiene and Tropical Medicine
- Investigators
- Rosalind Eggo, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552612
- Sponsor's protocol ID
- 2022-KEP-799
- Acronym
- OpenPROMPT
- Status last verified
- Mar 2024
- First submitted
- 21 Sep 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36806073
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality-of-life in Patients With Long COVID: Harnessing the Scale of Big Data to Quantify the Health and Economic Costs
- ClinicalTrials.gov ID
- NCT05552612
- Acronym / sponsor ID
- OpenPROMPT / 2022-KEP-799
- Conditions
- Long COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,574 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long COVID | – | –Patients with Long COVID |
| Without Long COVID | – | –Patients who do not have Long COVID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who live in England
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-related quality of life
Time frame: day 0
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 36806073Herrett 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalind Eggo, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05552612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.