Exploring the Experiences, Expectations and Preferences of Patients With the UHS COVID-19 Follow-up Clinic

NCT05799482 | Unknown

• 1 other identifier: RHM MED1959
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Qualitative Interview

  Experiences, preferences and expectations of patients receiving care in the UHS COVID-19 follow-up clinic

  12 months

Study Arms (2)

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

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).

Other: Qualitative Interview

Interventions

Qualitative Interview OTHER

Qualitative, semi-structured interview

Prospective, longitudinal arm; Retrospective cross-sectional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

Judit Varkonyi-Sepp

Southampton, Hampshire, SO166YD, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 32839287 BACKGROUND

• Arnold 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.

  PMID: 33273026 BACKGROUND

• Wallis 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.

  PMID: 36316730 BACKGROUND

• Wallis 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.

  PMID: 34020644 BACKGROUND

Related Links

• HRA amendment guidance

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 5, 2023
• Study Start: August 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: April 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)