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LOng COvid Multidisciplinary Consortium: Optimising Treatments and servIces Across the NHS (LOCOMOTION) (LOCOMOTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05057260
Recruitment Status : Not yet recruiting
First Posted : September 27, 2021
Last Update Posted : October 4, 2021
Sponsor:
Collaborators:
Imperial College London
University of Oxford
University of Exeter
King's College London
University of Manchester
University of Dundee
Leeds Community Healthcare NHS Trust
Oxford University Hospitals NHS Trust
Imperial College Healthcare NHS Trust
University Hospitals, Leicester
Birmingham Community Healthcare NHS Trust
Belfast Health and Social Care
NHS Tayside
Newcastle Upon Tyne NHS Trust
NHS Wales University Hospital of Wales
Information provided by (Responsible Party):
Dr Manoj Sivan, University of Leeds

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.


Condition or disease Intervention/treatment
COVID-19 Other: No drug invervention

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Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LOng COvid Multidisciplinary Consortium: Optimising Treatments and servIces Across the NHS (LOCOMOTION)
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Long Covid cohort
Long Covid patients managed in the 10 participating sites
Other: No drug invervention
No clinical trial




Primary Outcome Measures :
  1. European Quality of Life Five Dimensions [ Time Frame: 2 years ]
    Quality of Life VAS score min 0 max 100

  2. COVID-19 Yorkshire Rehabilitation Scale [ Time Frame: 2 years ]
    Symptom severity (min 0 max 100) and functional disability (min 0 max 50) and health state (min 0 max 10)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.)
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05057260


Contacts
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Contact: Manoj Sivan, MD 01133922564 m.sivan@leeds.ac.uk

Sponsors and Collaborators
University of Leeds
Imperial College London
University of Oxford
University of Exeter
King's College London
University of Manchester
University of Dundee
Leeds Community Healthcare NHS Trust
Oxford University Hospitals NHS Trust
Imperial College Healthcare NHS Trust
University Hospitals, Leicester
Birmingham Community Healthcare NHS Trust
Belfast Health and Social Care
NHS Tayside
Newcastle Upon Tyne NHS Trust
NHS Wales University Hospital of Wales
Investigators
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Principal Investigator: Manoj Sivan, MD University of Leeds
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Manoj Sivan, Associate Professor and Consultant in Rehabilitation Medicine, University of Leeds
ClinicalTrials.gov Identifier: NCT05057260    
Other Study ID Numbers: 303623
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No