Clinical Trials Logo

Clinical Trial Summary

Background: Long Covid (LC) affects over one million people in the UK, it has various symptoms and impacts daily life. Although there are 83 LC clinics in England, most people have not had access to them, and waiting times to be seen are long. We realise the urgency for LC patients to access prompt and appropriate care in clinics and doctors' surgeries, as well as manage their symptoms effectively at home. Aim:Our research aims to produce a 'gold standard' for care by analysing what is happening to patients now, creating new systems of care and evaluating them to establish best practice. Outline Of Research: This research has been developed with LC patients and will continue to include patients working as equal partners. Key priorities of LC patients are: correct clinical assessment; advice and treatment; and help with returning to work and other roles. This research is also based on the experience of a wide range of NHS professionals already treating people in ten LC clinics across the UK, and led by academics (universities) with links to other LC funded studies. The research will take place in three settings: LC clinics; at home (including self-monitoring on a mobile device using a set of questions on symptoms built into an app); and in doctors' surgeries. We will track where patients are being referred or not referred, and learn from the experience of clinics by interviewing patients and recording outcomes. Throughout, specialists in 'Healthcare Inequality' will reach people who are not accessing clinics. We will put in place new processes in clinics and doctors' surgeries, monitored throughout to make sure they are the correct standard, accessible for patients and staff, and cost-effective. Outcomes: Comparing findings across our partnership of ten LC Clinics we will learn more about treatment, providing real-time education to other healthcare staff and patients, and establishing a 'gold standard' that can be shared within England and the rest of the UK.

Clinical Trial Description

Background: Long COVID (LC) or Post-COVID syndrome affects up to one million people in the UK and is a syndrome of persistent and fluctuating symptoms, with underlying organ dysfunction and multimorbidity. England has 83 dedicated multidisciplinary LC clinics (with no funding yet in Scotland, Wales or Northern Ireland), but these are unable to meet the growing demand and many patients are currently not getting timely care. There is an urgent need to develop a UK-wide efficient integrated LC service. Aim: We will optimise LC management across three settings of care - LC specialist clinics (Work stream (WS)1); Homes/self-management (WS2) and Primary care (WS3). Methods: WS1: The management options for multisystem medical problems will be standardised to derive best practice guidance using a Quality Improvement collaborative involving embedded clinician researchers from 10 UK-wide LC clinics. Experience-based co-design with patients and healthcare professionals will inform training and resources for both. Ethnic and socioeconomic inequalities of care and vocational challenges of patients will be addressed using qualitative and mixed methods approaches. WS2: A digital platform incorporating wearable technology will capture symptom fluctuations and individual condition triggers to enable biofeedback for self-management. Core outcomes measures including the first published LC patient-reported outcome measure (Yorkshire Rehabilitation Scale C19 YRS, developed by the co-CI) will be made available on the digital platform for monitoring and directing interventions remotely. WS3: Existing primary care and LC clinic integrated data will assist in developing and evaluating new integrated cost-effective service models that will enable the best practice guidance developed in WS1 to be delivered at point of contact in primary care. We have links with previously funded NIHR LC projects to enable co-learning and maximising impact. PPI/E: From understanding how COVID-19 has disproportionately affected different communities, we have created a seven-member core PPI Advisory Group (PAG) that is inclusive of different cultural, ethnic and socio-economic groups. They have attended our proposal research planning meetings and met separately to examine and develop the research aim/objectives/ questions, ensuring these are aligned with the key research priorities of patients with LC as well as representing different patient needs. PAG members have lived experience of LC, and bring information and experience from participating in patient support groups including Long Covid Support (n=38K), doctors with LC and a LC Physio. PAG members have been involved in research design for previous NIHR bids, have acted as patient representatives on the NHS England LC Taskforce, and have led national audits on access to LC clinics. The PPI Lead is a founding member of the LC Employment Taskforce of Society of Occupational Medicine and a representative on the Access to WHO Covid Therapies Accelerator (ACT-A) committee. Some members meet weekly as members of Employment Steering Group of the LC Support Group including liaising with Unions. In this study, the PAG will meet quarterly to review progress, ensure the research is answering the most relevant urgent issues in LC care and that the findings are translational and rapidly informing LC care. To ensure the different demographics of each of the ten LC Clinics are represented, two PPI members from each Clinic will be invited to join a Patient Advisory Network (PAN). Information will flow between the PAG and the PAN via the PPI Lead and Co-lead, ensuring that the voices of the PAN are represented within the PAG, and that they receive updates about research activity in the same way as PAG members. With support from the PPI Lead and Co-lead, PAN members will have an active role in gathering and sharing local intelligence about various aspects of the LC experience and LC Clinic access from LC patients representative of different groups e.g. via the voluntary sector and GP surgeries in different locations, including remote areas where there may be more elderly people with less access to LC clinics. The PPI Facilitator will provide the PAN members with PPI training, and provide them with the appropriate support needed to carry these activities out and contribute to the PAG. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05057260
Study type Observational
Source University of Leeds
Contact Manoj Sivan, MD
Phone 01133922564
Email [email protected]
Status Not yet recruiting
Start date October 2021
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05047601 - A Post-Exposure Prophylaxis Study of PF-07321332/Ritonavir in Adult Household Contacts of an Individual With Symptomatic COVID-19 Phase 3
Suspended NCT04394884 - Pathogenesis of BTK-mediated Hyper-Inflammatory Responses in COVID-19 (RESPOND)
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Active, not recruiting NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Active, not recruiting NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Recruiting NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Active, not recruiting NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Recruiting NCT04528901 - Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital)
Recruiting NCT04357990 - Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19 N/A
Active, not recruiting NCT04527471 - Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Recruiting NCT05047445 - A First Time in Human Phase 1 Open-Label Study of the COVIDITY Vaccine Administered by Needle-free Injection Phase 1
Recruiting NCT05022329 - COVID-19 Vaccine Boosters in Patients With CKD Phase 2/Phase 3
Recruiting NCT05041907 - Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) Phase 2
Not yet recruiting NCT04990466 - Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine. Phase 2/Phase 3
Not yet recruiting NCT05032976 - Comirnaty Korea PMS
Recruiting NCT04661462 - Health After Covid-19 in Tyrol
Not yet recruiting NCT04446065 - Previfenon® as Chemoprophylaxis of COVID-19 in Health Workers Phase 2/Phase 3
Recruiting NCT04526054 - Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients N/A