[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542797":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":308,"collaborators":310,"id":332,"slug":333,"hasResults":334,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":334,"sex":340,"minAge":341,"maxAge":18,"enrollmentInfo":342,"targetDuration":18,"studyType":345,"phases":346,"briefSummary":348,"conditions":349,"keywords":352,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":366},{"fullName":5,"class":6},"Guy's and St Thomas' NHS Foundation Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Supported Rescue Pack Arm","EXPERIMENTAL","All patients in the SRP arm will receive 1) a rescue pack (prednisolone and antibiotics for 5 days); 2) a written rescue pack management plan based on the Asthma-Lung UK plan; and 3) twice-weekly automated telephone symptom reminder calls for 90 days (with preferred language as needed). The reminder phone calls (to home telephone or mobile) will ask questions aligned to the written management plan, with patients asked to press the telephone keys 0-9 depending on the answer to the questions. Any patient that has required the use of their rescue pack within 90 days of discharge, will be re-issued with a rescue pack by the central study team and will be sent to the patient home.",[13],"Combination Product: Supported rescue pack",{"label":15,"type":16,"description":17,"interventionNames":18},"No Rescue Pack Arm","NO_INTERVENTION","In this arm, patients will be randomised to receive no rescue packs on discharge. We will very carefully characterise the support provided to people in this arm, upon discharge from hospital, including any access to rescue packs in the community (which we will report, but not modify).",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"COMBINATION_PRODUCT","Supported rescue pack","1\\) a rescue pack (prednisolone and antibiotics for 5 days); 2) a written rescue pack management plan based on the Asthma-Lung UK plan; and 3) twice-weekly automated telephone symptom reminder calls for 90 days (with preferred language as needed). The reminder phone calls (to home telephone or mobile) will ask questions aligned to the written management plan",[9],[26],{"name":27,"affiliation":28,"role":29},"Mona Bafadhel, Professor","King's College London","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","+44207 848 0606","mona.bafadhel@kcl.ac.uk",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Trial Manager","+44 20 7848 0532","rapid-rescue@kcl.ac.uk",[40,52,61,69,77,85,93,101,109,117,125,133,141,150,155,160,165,173,181,189,197,205,213,221,229,237,245,253,261,269,277,285,293,301],{"facility":41,"status":42,"city":43,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":18},"Barnsley Hospital NHS Foundation Trust","RECRUITING","Barnsley","United Kingdom","UK",{"type":47,"coordinates":48},"Point",[49,50],-1.48333,53.55,{"lat":50,"lon":49},{"facility":53,"status":54,"city":55,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":56,"geoPoint":60,"contacts":18},"University Hospitals Birminham NHS Foundation Trust","NOT_YET_RECRUITING","Birmingham",{"type":47,"coordinates":57},[58,59],-1.89983,52.48142,{"lat":59,"lon":58},{"facility":62,"status":54,"city":63,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":64,"geoPoint":68,"contacts":18},"Blackpool Teaching Hospitals","Blackpool",{"type":47,"coordinates":65},[66,67],-3.05,53.81667,{"lat":67,"lon":66},{"facility":70,"status":54,"city":71,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":72,"geoPoint":76,"contacts":18},"Bradford Teaching Hospitals NHS Foundation Trust","Bradford",{"type":47,"coordinates":73},[74,75],-1.75206,53.79391,{"lat":75,"lon":74},{"facility":78,"status":42,"city":79,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":80,"geoPoint":84,"contacts":18},"University Hospitals Sussex NHS Foundation Trust","Brighton",{"type":47,"coordinates":81},[82,83],-0.13947,50.82838,{"lat":83,"lon":82},{"facility":86,"status":54,"city":87,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":88,"geoPoint":92,"contacts":18},"North Bristol University Trust","Bristol",{"type":47,"coordinates":89},[90,91],-2.59665,51.45523,{"lat":91,"lon":90},{"facility":94,"status":42,"city":95,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":96,"geoPoint":100,"contacts":18},"County Durham and Darlington NHS Foundation Trust","Durham",{"type":47,"coordinates":97},[98,99],-1.57566,54.77676,{"lat":99,"lon":98},{"facility":102,"status":54,"city":103,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":104,"geoPoint":108,"contacts":18},"Gateshead NHS Foundation Trust","Gateshead",{"type":47,"coordinates":105},[106,107],-1.60168,54.96209,{"lat":107,"lon":106},{"facility":110,"status":42,"city":111,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":112,"geoPoint":116,"contacts":18},"East Suffolk and North Essex Foundation Trust","Ipswich",{"type":47,"coordinates":113},[114,115],1.15545,52.05917,{"lat":115,"lon":114},{"facility":118,"status":54,"city":119,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":120,"geoPoint":124,"contacts":18},"University Hospitals of Morecambe Bay NHS Foundation Trust","Lancaster",{"type":47,"coordinates":121},[122,123],-2.79988,54.04649,{"lat":123,"lon":122},{"facility":126,"status":54,"city":127,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":128,"geoPoint":132,"contacts":18},"University Hospitals of Leicester NHS Trust","Leicester",{"type":47,"coordinates":129},[130,131],-1.13169,52.6386,{"lat":131,"lon":130},{"facility":134,"status":54,"city":135,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":136,"geoPoint":140,"contacts":18},"Cardiff and Vale University Health Board","Llandough",{"type":47,"coordinates":137},[138,139],-3.44722,51.44556,{"lat":139,"lon":138},{"facility":5,"status":54,"city":142,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"London",{"type":47,"coordinates":144},[145,146],-0.12574,51.50853,{"lat":146,"lon":145},[149],{"name":27,"role":29,"phone":18,"phoneExt":18,"email":18},{"facility":151,"status":54,"city":142,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":152,"geoPoint":154,"contacts":18},"Imperial College Healthcare NHS Trust",{"type":47,"coordinates":153},[145,146],{"lat":146,"lon":145},{"facility":156,"status":54,"city":142,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":157,"geoPoint":159,"contacts":18},"King's College Hospital",{"type":47,"coordinates":158},[145,146],{"lat":146,"lon":145},{"facility":161,"status":54,"city":142,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":162,"geoPoint":164,"contacts":18},"London North West University Healthcare NHS Trust",{"type":47,"coordinates":163},[145,146],{"lat":146,"lon":145},{"facility":166,"status":54,"city":142,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":167,"geoPoint":169,"contacts":170},"Royal Free London NHS Foundation Trust",{"type":47,"coordinates":168},[145,146],{"lat":146,"lon":145},[171],{"name":172,"role":29,"phone":18,"phoneExt":18,"email":18},"John Hurst, Professor",{"facility":174,"status":54,"city":175,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":176,"geoPoint":180,"contacts":18},"Maidstone and Tunbridge Wells NHS Trust","Maidstone",{"type":47,"coordinates":177},[178,179],0.51667,51.26667,{"lat":179,"lon":178},{"facility":182,"status":54,"city":183,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":184,"geoPoint":188,"contacts":18},"South Tees NHS Foundation Trust","Middlesbrough",{"type":47,"coordinates":185},[186,187],-1.23483,54.57623,{"lat":187,"lon":186},{"facility":190,"status":54,"city":191,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":192,"geoPoint":196,"contacts":18},"Milton Keynes University Hospital NHS Foundation Trust","Milton Keynes",{"type":47,"coordinates":193},[194,195],-0.75583,52.04172,{"lat":195,"lon":194},{"facility":198,"status":54,"city":199,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":200,"geoPoint":204,"contacts":18},"Newcastle Upon Tyne Hospitals NHS Foundation Trust","Newcastle upon Tyne",{"type":47,"coordinates":201},[202,203],-1.61396,54.97328,{"lat":203,"lon":202},{"facility":206,"status":42,"city":207,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":208,"geoPoint":212,"contacts":18},"Nottingham University Hospitals Trust","Nottingham",{"type":47,"coordinates":209},[210,211],-1.15047,52.9536,{"lat":211,"lon":210},{"facility":214,"status":42,"city":215,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":216,"geoPoint":220,"contacts":18},"Oxford University Hospitals NHS Foundation Trust","Oxford",{"type":47,"coordinates":217},[218,219],-1.25596,51.75222,{"lat":219,"lon":218},{"facility":222,"status":42,"city":223,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":224,"geoPoint":228,"contacts":18},"Rotherham NHS Foundation Trust","Rotherham",{"type":47,"coordinates":225},[226,227],-1.35678,53.43012,{"lat":227,"lon":226},{"facility":230,"status":54,"city":231,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":232,"geoPoint":236,"contacts":18},"University Hospital Southampton NHS Foundation Trust","Shirley",{"type":47,"coordinates":233},[234,235],-1.81952,52.41074,{"lat":235,"lon":234},{"facility":238,"status":54,"city":239,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":240,"geoPoint":244,"contacts":18},"Frimley Health NHS Foundation Trust","Slough",{"type":47,"coordinates":241},[242,243],-0.59541,51.50949,{"lat":243,"lon":242},{"facility":246,"status":54,"city":247,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":248,"geoPoint":252,"contacts":18},"South Tyneside and Sunderland NHS Trust","South Shields",{"type":47,"coordinates":249},[250,251],-1.4323,54.99859,{"lat":251,"lon":250},{"facility":254,"status":42,"city":255,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":256,"geoPoint":260,"contacts":18},"Southport and Formby District General Hospital","Southport",{"type":47,"coordinates":257},[258,259],-3.01008,53.64581,{"lat":259,"lon":258},{"facility":262,"status":42,"city":263,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":264,"geoPoint":268,"contacts":18},"Stockport NHS Foundation Trust","Stockport",{"type":47,"coordinates":265},[266,267],-2.15761,53.40979,{"lat":267,"lon":266},{"facility":270,"status":42,"city":271,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":272,"geoPoint":276,"contacts":18},"North Tees and Hartlepool NHS Foundation Trust","Stockton-on-Tees",{"type":47,"coordinates":273},[274,275],-1.3187,54.56848,{"lat":275,"lon":274},{"facility":278,"status":54,"city":279,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":280,"geoPoint":284,"contacts":18},"Sherwood Forest Hospitals NHS Foundation Trust","Sutton in Ashfield",{"type":47,"coordinates":281},[282,283],-1.26135,53.12542,{"lat":283,"lon":282},{"facility":286,"status":54,"city":287,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":288,"geoPoint":292,"contacts":18},"Somerset Foundation Trust","Taunton",{"type":47,"coordinates":289},[290,291],-3.10293,51.01494,{"lat":291,"lon":290},{"facility":294,"status":54,"city":295,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":296,"geoPoint":300,"contacts":18},"Whiston Hospital","Whiston",{"type":47,"coordinates":297},[298,299],-2.78907,53.41997,{"lat":299,"lon":298},{"facility":286,"status":54,"city":302,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":303,"geoPoint":307,"contacts":18},"Yeovil",{"type":47,"coordinates":304},[305,306],-2.63211,50.94159,{"lat":306,"lon":305},{"type":309,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[311,312,314,316,318,320,322,324,326,328,330],{"name":28,"class":6},{"name":313,"class":6},"University College, London",{"name":315,"class":6},"Imperial College London",{"name":317,"class":6},"University of Cambridge",{"name":319,"class":6},"University of Southampton",{"name":321,"class":6},"University of Nottingham",{"name":323,"class":6},"University of Leicester",{"name":238,"class":325},"UNKNOWN",{"name":327,"class":6},"Newcastle University",{"name":329,"class":6},"University of Bristol",{"name":331,"class":325},"Asthma and Lung UK","100542797","phase-3-supported-rescue-packs-post-discharge-in-chronic-obstructive-pulmonary-disease-100542797",false,"NCT06347536","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","RAPID","Inclusion Criteria:\n\n* Age ≥ 40 years\n* 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.\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Individuals who require invasive ventilation during the hospital admission\n* Patients who have an expected survival of less than 90 days\n* Patients with signs of new consolidation on chest X-ray (if available).\n* Individuals who have been discharged to a residential or nursing home to residential or nursing home.\n* Individuals who are unable to manage a supported self-management plan.\n* Individuals with no access to telephone.\n* Individuals who are already taking part in an interventional trial.\n* Previous participation in the RAPID trial.","ALL","40 Years",{"count":343,"type":344},1400,"ESTIMATED","INTERVENTIONAL",[347],"PHASE3","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.\n\nSevere 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.\n\nA 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\u002Ftext 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.",[350,351],"COPD","COPD Exacerbation",[350,353,354,355,356],"exacerbation","hospital admission","rescue packs","self-management support","2025-02-06",{"date":359,"type":360},"2025-02-10","ACTUAL",{"date":362,"type":360},"2025-01-30",{"date":364,"type":344},"2027-12-31",{"name":5,"class":6},34]