LOng COvid Multidisciplinary Consortium: Optimising Treatments and servIces Across the NHS (LOCOMOTION)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- European Quality of Life Five Dimensions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Inability to independently complete electronic or paper-based outcome measures, questionnaires or other research-based paperwork.
- •Unable to give Informed Consent.
结局指标
主要结局
European Quality of Life Five Dimensions
时间窗: 2 years
Quality of Life VAS score min 0 max 100
COVID-19 Yorkshire Rehabilitation Scale
时间窗: 2 years
Symptom severity (min 0 max 100) and functional disability (min 0 max 50) and health state (min 0 max 10)
次要结局
未报告次要终点
研究者
Dr Manoj Sivan
Associate Professor and Consultant in Rehabilitation Medicine
University of Leeds