COVID-19NCT05799482
Exploring the Experiences, Expectations and Preferences of Patients With the UHS COVID-19 Follow-up Clinic
An observational study of COVID-19, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
People who are older, those who had underlying other health conditions and people living in poorer communities are at increased risk of complications and worse outcome from COVID-19. They are more likely to be admitted to hospital with this virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Qualitative Interview
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2023to 1 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The research population of interest for this study is patients followed up in the UHS COVID follow-up clinic following diagnosed COVID-19 infection. This will include all patients deemed appropriate by their clinical team to receive this clinical service
Who may be able to join
- Age 18 or over
- Must have had a diagnosis of COVID-19 infection
- Must have been discharged from hospital following admission with Covid-19 infection OR
- Must have been referred to by their GP and accepted into the UHS COVID follow-up clinic
- Retrospective study arm: must have been receiving care in the UHS COVID follow-up clinic at any stage in the last 12 months
- Prospective study arm: must be newly referred to UHS COVID follow-up clinic
- Conversational level of English that does not require a translator
- Giving written informed consent
Who cannot join
- Less than 18 years old
- Not followed up at UHS post discharge from hospital after admission for COVID-19 infection OR
- Not accepted into the UHS COVID follow-up clinic
- Retrospective study arm: received care in the COVID follow-up clinic more than 12 months prior to enrolment in the study
- Unwilling or unable to give informed consent
- Unwilling or unable to participate in the interview
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Judit Varkonyi-Sepp
Southampton, Hampshire, SO166YD
Judit Varkonyi-Sepp, Principle Investigator, 023 8120 6315, j.varkonyi-sepp@soton.ac.uk
Ben Marshall, Dr
About this study
Official title: pATienT ExperieNces wiTh covId fOllow-up Clinic
People who are older, those who had underlying other health conditions and people living in poorer communities are at increased risk of complications and worse outcome from COVID-19. They are more likely to be admitted to hospital with this virus. In the UK in 2020, over 130,000 people were admitted to hospital with COVID-19. Whilst admission rates fell since then, there is a need to understand better the potential impact of the many symptoms resulting from a COVID-19 infection on patients and the health services. To achieve this, the respiratory team in the University Hospital set up a COVID-19 follow-up clinic for patients who had COVID-19 infection. In this clinic, for a period of 12 weeks patients have chest X-rays, blood tests and virtual medical consultations. The clinic has been running for three years.
This study will be conducted study to understand the expectations, preferences and experiences of patients who have been receiving care in the clinic. On one hand, patients who have received care in the clinic during the last yearwill be interviewed. On the other hand, patients who have been newly referred to the clinic will be interviewed before they start it and also after 12 weeks about how their expectations have been met. Patients will be identified by their clinical team and after consenting to take part in the study, they will be interviewed by qualitative researchers who will also analyse the interview data using scientific methods. The results of this study will help understanding whether changes are to be made to this clinic and also inform future similar services should they be needed.
Read the detailed description
The long-term consequences of COVID-19 remain unclear. People who are older, have medical comorbidities and those who live in areas of increased socio-economic deprivation are at increased risk of poor outcome and complications from COVID-19 (1).
In 2020, over 130,000 people have been admitted to hospital with COVID-19 in the UK (2). Whilst admission rates fell, the potential impact of 'post-COVID' syndromes on patients and the health services need longer-term further investigation.
The British Thoracic Society (BTS) COVID-19 Guidance advises follow-up of patients who had COVID-19, depending on whether the patient required intensive/higher care versus ward/community care.1. For mild/moderate disease, BTS recommends virtual follow-up with a chest X-ray (1). A wide range of symptoms and reduced HRQoL has been detected in these patients reinforcing the importance of a implementing a holistic approach advocated by the BTS and other guidelines (2).
The COVID follow-up service was set up in 2020 in the Southampton General Hospital to provide longer-term care to patients with COVID-19 chest symptoms. The changing nature of the pandemic and an extension of the cohort from patients discharged after hospital stay for COVID-19 infection to previously not hospitalised patients referred by GPs call for an evaluation of the COVID follow-up clinic to explore patient experiences, expectations, and preferences with this service.
- Conditions
- COVID-19
- Being tested
- Qualitative Interview
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative InterviewOther
Qualitative, semi-structured interview
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cross-sectional arm | One-to-one semi-structured interviews will be conducted with patients who have received care in the UHS COVID follow-up clinics in no more than 12 months prior to study enrolment. Interviews will be conducted at one time point Receives: Other: Qualitative Interview | |
| Prospective, longitudinal arm | One-to-one semi-structured interviews will be conducted with patients with confirmed prior COVID-19 infection who are scheduled to receive care in the UHS COVID follow-up clinics. Interviews will be conducted before attending the first clinic appointment (baseline) and after discharge from the clinic (at 12 weeks). Receives: Other: Qualitative Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Interview
Experiences, preferences and expectations of patients receiving care in the UHS COVID-19 follow-up clinic
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Aug 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799482
- Sponsor's protocol ID
- RHM MED1959
- Status last verified
- Sep 2023
- First submitted
- 4 Apr 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Throughout the study, the researchers will be working with the Public and Patient Involvement group to develop a dissemination strategy of the results to the study participants and other stakeholders and/or the public as appropriate.
Publications
George PM, Barratt SL, Condliffe R, Desai SR, Devaraj A, Forrest I, Gibbons MA, Hart N, Jenkins RG, McAuley DF, Patel BV, Thwaite E, Spencer LG. Respiratory follow-up of patients with COVID-19 pneumonia. Thorax. 2020 Nov;75(11):1009-1016. doi: 10.1136/thoraxjnl-2020-215314. Epub 2020 Aug 24.
PubMed 32839287Arnold DT, Hamilton FW, Milne A, Morley AJ, Viner J, Attwood M, Noel A, Gunning S, Hatrick J, Hamilton S, Elvers KT, Hyams C, Bibby A, Moran E, Adamali HI, Dodd JW, Maskell NA, Barratt SL. Patient outcomes after hospitalisation with COVID-19 and implications for follow-up: results from a prospective UK cohort. Thorax. 2021 Apr;76(4):399-401. doi: 10.1136/thoraxjnl-2020-216086. Epub 2020 Dec 3.
PubMed 33273026Wallis TJ, Welham B, Kong A, Morelli T, Azim A, Horno J, Wilkinson M, Burke H, Freeman A, Wilkinson TM, Jones MG, Marshall BG. Predicting the risk of chest radiograph abnormality 12-weeks post hospitalisation with SARS CoV-2 PCR confirmed COVID-19. Respir Res. 2022 Oct 31;23(1):297. doi: 10.1186/s12931-022-02217-0.
PubMed 36316730Wallis TJM, Heiden E, Horno J, Welham B, Burke H, Freeman A, Dexter L, Fazleen A, Kong A, McQuitty C, Watson M, Poole S, Brendish NJ, Clark TW, Wilkinson TMA, Jones MG, Marshall BG. Risk factors for persistent abnormality on chest radiographs at 12-weeks post hospitalisation with PCR confirmed COVID-19. Respir Res. 2021 May 21;22(1):157. doi: 10.1186/s12931-021-01750-8.
PubMed 34020644
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- pATienT ExperieNces wiTh covId fOllow-up Clinic
- ClinicalTrials.gov ID
- NCT05799482
- Acronym / sponsor ID
- RHM MED1959
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 5 Apr 2023 (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.
People who are older, those who had underlying other health conditions and people living in poorer communities are at increased risk of complications and worse outcome from COVID-19. They are more likely to be admitted to hospital with this virus. In the UK in 2020, over 130,000 people were admitted to hospital with COVID-19. Whilst admission rates fell since then, there is a need to understand better the potential impact of the many symptoms resulting from a COVID-19 infection on patients and the health services. To achieve this, the respiratory team in the University Hospital set up a COVID-19 follow-up clinic for patients who had COVID-19 infection. In this clinic, for a period of 12 weeks patients have chest X-rays, blood tests and virtual medical consultations. The clinic has been running for three years.
This study will be conducted study to understand the expectations, preferences and experiences of patients who have been receiving care in the clinic. On one hand, patients who have received care in the clinic during the last yearwill be interviewed. On the other hand, patients who have been newly referred to the clinic will be interviewed before they start it and also after 12 weeks about how their expectations have been met. Patients will be identified by their clinical team and after consenting to take part in the study, they will be interviewed by qualitative researchers who will also analyse the interview data using scientific methods. The results of this study will help understanding whether changes are to be made to this clinic and also inform future similar services should they be needed.
Detailed description
The long-term consequences of COVID-19 remain unclear. People who are older, have medical comorbidities and those who live in areas of increased socio-economic deprivation are at increased risk of poor outcome and complications from COVID-19 (1).
In 2020, over 130,000 people have been admitted to hospital with COVID-19 in the UK (2). Whilst admission rates fell, the potential impact of 'post-COVID' syndromes on patients and the health services need longer-term further investigation.
The British Thoracic Society (BTS) COVID-19 Guidance advises follow-up of patients who had COVID-19, depending on whether the patient required intensive/higher care versus ward/community care.1. For mild/moderate disease, BTS recommends virtual follow-up with a chest X-ray (1). A wide range of symptoms and reduced HRQoL has been detected in these patients reinforcing the importance of a implementing a holistic approach advocated by the BTS and other guidelines (2).
The COVID follow-up service was set up in 2020 in the Southampton General Hospital to provide longer-term care to patients with COVID-19 chest symptoms. The changing nature of the pandemic and an extension of the cohort from patients discharged after hospital stay for COVID-19 infection to previously not hospitalised patients referred by GPs call for an evaluation of the COVID follow-up clinic to explore patient experiences, expectations, and preferences with this service.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cross-sectional arm | – | Other: Qualitative InterviewOne-to-one semi-structured interviews will be conducted with patients who have received care in the UHS COVID follow-up clinics in no more than 12 months prior to study enrolment. Interviews will be conducted at one time point |
| Prospective, longitudinal arm | – | Other: Qualitative InterviewOne-to-one semi-structured interviews will be conducted with patients with confirmed prior COVID-19 infection who are scheduled to receive care in the UHS COVID follow-up clinics. Interviews will be conducted before attending the first clinic appointment (baseline) and after discharge from the clinic (at 12 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The research population of interest for this study is patients followed up in the UHS COVID follow-up clinic following diagnosed COVID-19 infection. This will include all patients deemed appropriate by their clinical team to receive this clinical service
Key inclusion criteria (8 listed)
- Age 18 or over
- Must have had a diagnosis of COVID-19 infection
- Must have been discharged from hospital following admission with Covid-19 infection OR
- Must have been referred to by their GP and accepted into the UHS COVID follow-up clinic
- Retrospective study arm: must have been receiving care in the UHS COVID follow-up clinic at any stage in the last 12 months
Key exclusion criteria (6 listed)
- Less than 18 years old
- Not followed up at UHS post discharge from hospital after admission for COVID-19 infection OR
- Not accepted into the UHS COVID follow-up clinic
- Retrospective study arm: received care in the COVID follow-up clinic more than 12 months prior to enrolment in the study
- Unwilling or unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative InterviewQualitative, semi-structured interview | Other | Prospective, longitudinal arm, Retrospective cross-sectional arm |
Primary outcome
Qualitative Interview
Time frame: 12 months
Experiences, preferences and expectations of patients receiving care in the UHS COVID-19 follow-up clinic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 32839287George PM, Barratt SL, Condliffe R, Desai SR, Devaraj A, Forrest I, Gibbons MA, Hart N, Jenkins RG, McAuley DF, Patel BV, Thwaite E, Spencer LG. Respiratory follow-up of patients with COVID-19 pneumonia. Thorax. 2020 Nov;75(11):1009-1016. doi: 10.1136/thoraxjnl-2020-215314. Epub 2020 Aug 24.
- Background: PubMed 33273026Arnold DT, Hamilton FW, Milne A, Morley AJ, Viner J, Attwood M, Noel A, Gunning S, Hatrick J, Hamilton S, Elvers KT, Hyams C, Bibby A, Moran E, Adamali HI, Dodd JW, Maskell NA, Barratt SL. Patient outcomes after hospitalisation with COVID-19 and implications for follow-up: results from a prospective UK cohort. Thorax. 2021 Apr;76(4):399-401. doi: 10.1136/thoraxjnl-2020-216086. Epub 2020 Dec 3.
- Background: PubMed 36316730Wallis TJ, Welham B, Kong A, Morelli T, Azim A, Horno J, Wilkinson M, Burke H, Freeman A, Wilkinson TM, Jones MG, Marshall BG. Predicting the risk of chest radiograph abnormality 12-weeks post hospitalisation with SARS CoV-2 PCR confirmed COVID-19. Respir Res. 2022 Oct 31;23(1):297. doi: 10.1186/s12931-022-02217-0.
- Background: PubMed 34020644Wallis TJM, Heiden E, Horno J, Welham B, Burke H, Freeman A, Dexter L, Fazleen A, Kong A, McQuitty C, Watson M, Poole S, Brendish NJ, Clark TW, Wilkinson TMA, Jones MG, Marshall BG. Risk factors for persistent abnormality on chest radiographs at 12-weeks post hospitalisation with PCR confirmed COVID-19. Respir Res. 2021 May 21;22(1):157. doi: 10.1186/s12931-021-01750-8.
- HRA amendment guidanceLink provided by the sponsor.
- Individual participant dataSharing planned: No. Throughout the study, the researchers will be working with the Public and Patient Involvement group to develop a dissemination strategy of the results to the study participants and other stakeholders and/or the public as appropriate.
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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.
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 COVID-19, run by University Hospital Southampton NHS Foundation Trust 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Interview (time frame: 12 months). 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 NCT05799482, which also lists 4 linked publications.
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 21 Sep 2023.