NCT05057260

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 18, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

September 23, 2021

Last Update Submit

October 31, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • European Quality of Life Five Dimensions

    Quality of Life VAS score min 0 max 100

    2 years

  • COVID-19 Yorkshire Rehabilitation Scale

    Symptom severity (min 0 max 100) and functional disability (min 0 max 50) and health state (min 0 max 10)

    2 years

Study Arms (1)

Long Covid cohort

Long Covid patients managed in the 10 participating sites

Other: No drug invervention

Interventions

No clinical trial

Long Covid cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred into one of the ten Long Covid services by their General Practitioner (GP), or other clinicians (Positive Antigen or Antibody test is not required.)

You may qualify if:

  • Age 18 and over, receiving care for Long Covid symptoms at one of the participating LC sites.
  • Willing and able to consent for their data to be used for research and/or service evaluation purposes. Consent will be gathered via patient information sheet and formal recording of consent (on the phone application).

You may not qualify if:

  • Inability to independently complete electronic or paper-based outcome measures, questionnaires or other research-based paperwork.
  • Unable to give Informed Consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, Yorkshire, LS1 3EX, United Kingdom

RECRUITING

Related Publications (6)

  • Horton M, Smith AB, Milne R, Winch D, Rayner C, Halpin S, O'Connor R, Rocha Lawrence R, Greenwood DC, Bakerly ND, Evans R, Kwon J, Dawes H, Wood C, Williams P, Master H, Mansoubi M, De Kock JH, Mullard J, Ormerod M, Mir G, Petrou S, O'Connor DB, Sivan M; LOCOMOTION Consortium. Large-Scale Psychometric Assessment and Validation of the Modified COVID-19 Yorkshire Rehabilitation Scale Patient-Reported Outcome Measure for Long COVID or Post-COVID Syndrome. J Med Virol. 2026 Feb;98(2):e70816. doi: 10.1002/jmv.70816.

  • Lee C, Williams P, Abrahams A, Darbyshire J, Davies HE, De Kock J, Esmer U, Jones SA, Newey V, Scott J, Smith N, Winch D, Master H, Elkin S; LOCOMOTION Consortium. What Can We Learn Four Years On? A Multi-Centre Service Evaluation Exploring Symptoms, Functional Impact, Recovery and Care Pathways in Long Covid. Health Expect. 2025 Dec;28(6):e70435. doi: 10.1111/hex.70435.

  • Greenhalgh T, Darbyshire JL, Lee C, Ladds E, Ceolta-Smith J. What is quality in long covid care? Lessons from a national quality improvement collaborative and multi-site ethnography. BMC Med. 2024 Apr 15;22(1):159. doi: 10.1186/s12916-024-03371-6.

  • Lee C, Greenwood DC, Master H, Balasundaram K, Williams P, Scott JT, Wood C, Cooper R, Darbyshire JL, Gonzalez AE, Davies HE, Osborne T, Corrado J, Iftekhar N, Rogers N, Delaney B, Greenhalgh T, Sivan M; LOCOMOTION Consortium. Prevalence of orthostatic intolerance in long covid clinic patients and healthy volunteers: A multicenter study. J Med Virol. 2024 Mar;96(3):e29486. doi: 10.1002/jmv.29486.

  • Mullard JCR, Kawalek J, Parkin A, Rayner C, Mir G, Sivan M, Greenhalgh T. Towards evidence-based and inclusive models of peer support for long covid: A hermeneutic systematic review. Soc Sci Med. 2023 Mar;320:115669. doi: 10.1016/j.socscimed.2023.115669. Epub 2023 Jan 14.

  • Sivan M, Greenhalgh T, Darbyshire JL, Mir G, O'Connor RJ, Dawes H, Greenwood D, O'Connor D, Horton M, Petrou S, de Lusignan S, Curcin V, Mayer E, Casson A, Milne R, Rayner C, Smith N, Parkin A, Preston N, Delaney B; LOCOMOTION consortium. LOng COvid Multidisciplinary consortium Optimising Treatments and servIces acrOss the NHS (LOCOMOTION): protocol for a mixed-methods study in the UK. BMJ Open. 2022 May 17;12(5):e063505. doi: 10.1136/bmjopen-2022-063505.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Manoj Sivan, MD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manoj Sivan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Consultant in Rehabilitation Medicine

Study Record Dates

First Submitted

September 23, 2021

First Posted

September 27, 2021

Study Start

January 18, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

November 3, 2022

Record last verified: 2022-10

Locations