Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05057260 |
| Other study ID # |
303623 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 18, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
October 2022 |
| Source |
University of Leeds |
| Contact |
Manoj Sivan, MD |
| Phone |
01133922564 |
| Email |
m.sivan[@]leeds.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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.
