ICLEAR-EU - Palliative Care Intervention for Advanced COPD patients
Research type
Research Study
Full title
Evaluation of the ICLEAR-EU intervention to integrate palliative care in the treatment of people with advanced COPD and their family caregivers: An international stepped wedge cluster RCT in six European countries.
IRAS ID
341950
Contact name
Nancy Preston
Contact email
Sponsor organisation
Lancaster University
ISRCTN Number
ISRCTN45800298
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
The aim of the EU PAL-COPD project is to improve the quality of life and well-being of people living with advanced Chronic Obstructive Pulmonary Disease (COPD) by introducing palliative care alongside their usual respiratory care. Palliative care focuses on relieving symptoms and providing emotional, social, and practical support for patients and their families as the disease progresses. This study will test a new care approach called ICLEAR-EU, designed to help patients receive better coordinated care across hospitals, primary care, and community services.
ICLEAR-EU was originally developed in the United Kingdom and focuses on identifying patients' palliative care needs early, improving communication among healthcare teams, involving patients and families in care decisions, and regularly reviewing care plans. This approach helped decrease the number of hospital deaths and unnecessary hospital admissions while improving patient care. The EU PAL-COPD project has adapted this model for six countries: Belgium, the Netherlands, the United Kingdom, Denmark, Hungary, and Portugal.
The clinical trial will test the adapted ICLEAR-EU model in three hospitals in the UK to explore if it improves patient and family outcomes, reduces hospital readmissions, and makes better use of healthcare services. Researchers will also evaluate how easy it is to deliver the intervention and identify any challenges in different healthcare settings. The study will compare the new model with usual care by measuring patient well-being, family carer burden, hospital stays, and healthcare costs.
The study will include patients with advanced COPD, their caregivers (family/relatives), and healthcare providers. Patients with COPD and their caregivers will be followed for up to 90 days (+/- 1 week) after starting the intervention. The study will last two years and is funded by the European Union. Recruitment will take place in hospitals across the six participating countries.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0194
Date of REC Opinion
11 Jul 2025
REC opinion
Further Information Favourable Opinion