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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

Full criteria on ClinicalTrials.gov

Sites (34)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Barnsley Hospital NHS Foundation Trust
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BarnsleyUnited KingdomRecruiting
University Hospitals Birminham NHS Foundation Trust
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BirminghamUnited KingdomNot yet recruiting
Blackpool Teaching Hospitals
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BlackpoolUnited KingdomNot yet recruiting
Bradford Teaching Hospitals NHS Foundation Trust
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BradfordUnited KingdomNot yet recruiting
University Hospitals Sussex NHS Foundation Trust
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BrightonUnited KingdomRecruiting
North Bristol University Trust
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BristolUnited KingdomNot yet recruiting
County Durham and Darlington NHS Foundation Trust
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DurhamUnited KingdomRecruiting
Gateshead NHS Foundation Trust
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GatesheadUnited KingdomNot yet recruiting
East Suffolk and North Essex Foundation Trust
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IpswichUnited KingdomRecruiting
University Hospitals of Morecambe Bay NHS Foundation Trust
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LancasterUnited KingdomNot yet recruiting
University Hospitals of Leicester NHS Trust
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LeicesterUnited KingdomNot yet recruiting
Cardiff and Vale University Health Board
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LlandoughUnited KingdomNot yet recruiting
King's College Hospital
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LondonUnited KingdomNot yet recruiting
London North West University Healthcare NHS Trust
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LondonUnited KingdomNot yet recruiting
Guy's and St Thomas' NHS Foundation Trust
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LondonUnited KingdomNot yet recruiting
Imperial College Healthcare NHS Trust
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LondonUnited KingdomNot yet recruiting
Royal Free London NHS Foundation Trust
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LondonUnited KingdomNot yet recruiting
Maidstone and Tunbridge Wells NHS Trust
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MaidstoneUnited KingdomNot yet recruiting
South Tees NHS Foundation Trust
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MiddlesbroughUnited KingdomNot yet recruiting
Milton Keynes University Hospital NHS Foundation Trust
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Milton KeynesUnited KingdomNot yet recruiting
Newcastle Upon Tyne Hospitals NHS Foundation Trust
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Newcastle upon TyneUnited KingdomNot yet recruiting
Nottingham University Hospitals Trust
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NottinghamUnited KingdomRecruiting
Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomRecruiting
Rotherham NHS Foundation Trust
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RotherhamUnited KingdomRecruiting
University Hospital Southampton NHS Foundation Trust
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ShirleyUnited KingdomNot yet recruiting
Frimley Health NHS Foundation Trust
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SloughUnited KingdomNot yet recruiting
Southport and Formby District General Hospital
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SouthportUnited KingdomRecruiting
South Tyneside and Sunderland NHS Trust
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South ShieldsUnited KingdomNot yet recruiting
Stockport NHS Foundation Trust
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StockportUnited KingdomRecruiting
North Tees and Hartlepool NHS Foundation Trust
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Stockton-on-TeesUnited KingdomRecruiting
Sherwood Forest Hospitals NHS Foundation Trust
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Sutton in AshfieldUnited KingdomNot yet recruiting
Somerset Foundation Trust
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TauntonUnited KingdomNot yet recruiting
Whiston Hospital
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WhistonUnited KingdomNot yet recruiting
Somerset Foundation Trust
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YeovilUnited KingdomNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.