NCT06347536RecruitingPhase 3
Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease
Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease: An Open-label Multicenter Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality. Severe exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed. A multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone/text symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1400 (estimated)
- First submitted
- 19 Feb 2024
- Start date
- 30 Jan 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Diseases
- COPD
- NCT number
- NCT06347536
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1400
- From 30 Jan 2025 to the primary completion date, 31 Dec 2027
- 34 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in the RAPID trial.
Other
- Individuals who require invasive ventilation during the hospital admission
- Patients who have an expected survival of less than 90 days
- Patients with signs of new consolidation on chest X-ray (if available).
- Individuals who have been discharged to a residential or nursing home to residential or nursing home.
- Individuals who are unable to manage a supported self-management plan.
- Individuals with no access to telephone.
- Individuals who are already taking part in an interventional trial.
Who the study is looking for
- Age ≥ 40 years
- Individuals admitted to hospital with COPD exacerbation who have recently been discharged (discharged from ongoing support from secondary care team which includes hospital and virtual wards). Admission is defined as an episode in which a patient with an exacerbation of COPD is admitted to a ward and has stayed in hospital for 4 hours or more, including Emergency Medicine Centres, Medical Admission Units, Clinical Decision Units, short stay wards or similar but excludes patients treated transiently before being discharged from Emergency Department.
- Ability to provide written informed consent
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barnsley Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Barnsley | United Kingdom | Recruiting |
| University Hospitals Birminham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Not yet recruiting |
| Blackpool Teaching Hospitals Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Not yet recruiting |
| Bradford Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Bradford | United Kingdom | Not yet recruiting |
| University Hospitals Sussex NHS Foundation Trust Coordinator of this site? Confirm its status | Brighton | United Kingdom | Recruiting |
| North Bristol University Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Not yet recruiting |
| County Durham and Darlington NHS Foundation Trust Coordinator of this site? Confirm its status | Durham | United Kingdom | Recruiting |
| Gateshead NHS Foundation Trust Coordinator of this site? Confirm its status | Gateshead | United Kingdom | Not yet recruiting |
| East Suffolk and North Essex Foundation Trust Coordinator of this site? Confirm its status | Ipswich | United Kingdom | Recruiting |
| University Hospitals of Morecambe Bay NHS Foundation Trust Coordinator of this site? Confirm its status | Lancaster | United Kingdom | Not yet recruiting |
| University Hospitals of Leicester NHS Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Not yet recruiting |
| Cardiff and Vale University Health Board Coordinator of this site? Confirm its status | Llandough | United Kingdom | Not yet recruiting |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| London North West University Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Guy's and St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Royal Free London NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Maidstone and Tunbridge Wells NHS Trust Coordinator of this site? Confirm its status | Maidstone | United Kingdom | Not yet recruiting |
| South Tees NHS Foundation Trust Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Not yet recruiting |
| Milton Keynes University Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Milton Keynes | United Kingdom | Not yet recruiting |
| Newcastle Upon Tyne Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Not yet recruiting |
| Nottingham University Hospitals Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Rotherham NHS Foundation Trust Coordinator of this site? Confirm its status | Rotherham | United Kingdom | Recruiting |
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Shirley | United Kingdom | Not yet recruiting |
| Frimley Health NHS Foundation Trust Coordinator of this site? Confirm its status | Slough | United Kingdom | Not yet recruiting |
| Southport and Formby District General Hospital Coordinator of this site? Confirm its status | Southport | United Kingdom | Recruiting |
| South Tyneside and Sunderland NHS Trust Coordinator of this site? Confirm its status | South Shields | United Kingdom | Not yet recruiting |
| Stockport NHS Foundation Trust Coordinator of this site? Confirm its status | Stockport | United Kingdom | Recruiting |
| North Tees and Hartlepool NHS Foundation Trust Coordinator of this site? Confirm its status | Stockton-on-Tees | United Kingdom | Recruiting |
| Sherwood Forest Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Sutton in Ashfield | United Kingdom | Not yet recruiting |
| Somerset Foundation Trust Coordinator of this site? Confirm its status | Taunton | United Kingdom | Not yet recruiting |
| Whiston Hospital Coordinator of this site? Confirm its status | Whiston | United Kingdom | Not yet recruiting |
| Somerset Foundation Trust Coordinator of this site? Confirm its status | Yeovil | United Kingdom | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.