Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01655667
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2012-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38859}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-01', 'studyFirstSubmitDate': '2012-07-31', 'studyFirstSubmitQcDate': '2012-08-01', 'lastUpdatePostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diagnosis', 'Primary Care', 'Comorbidities', 'Healthcare utilisation'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '24717623', 'type': 'DERIVED', 'citation': 'Jones RC, Price D, Ryan D, Sims EJ, von Ziegenweidt J, Mascarenhas L, Burden A, Halpin DM, Winter R, Hill S, Kearney M, Holton K, Moger A, Freeman D, Chisholm A, Bateman ED; Respiratory Effectiveness Group. Opportunities to diagnose chronic obstructive pulmonary disease in routine care in the UK: a retrospective study of a clinical cohort. Lancet Respir Med. 2014 Apr;2(4):267-76. doi: 10.1016/S2213-2600(14)70008-6. Epub 2014 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'To characterise and understand the current UK COPD population including demographics, active comorbidities and missed opportunities for COPD diagnosis in the years previous to diagnosis', 'detailedDescription': "Using real-world primary care clinical databases, ascertain whether 1) trends in respiratory resource utilisation prior to COPD diagnosis (including lower respiratory tract infections \\[LRTIs\\], consultations and hospitalisations) could be used as 'flags' to aid earlier diagnosis, and 2) characterize comorbid conditions present at the time of COPD diagnosis, and evaluate the relationship to COPD disease severity and age at diagnosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects aged 40 years or older, with an electronically coded diagnosis of COPD made between 1990 and 2009, a minimum of three years continuous practice data including two years prior to and one year post diagnosis to ensure patients recieved COPD therapy post diagnosis (defined as two or more prescriptions for COPD therapies in the 12 months post diagnosis year 1). COPD therapies included short- and long-acting bronchodilators, inhaled corticosteroids, theophylline and leukotriene receptor antagonists.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 40 years or older\n* Electronically coded diagnosis of COPD made between 1990 and 2009\n* A minimum of three years continuous practice data including two years prior to and one year post diagnosis to ensure patients recieved COPD therapy post diagnosis\n* Recieved two or more prescriptions for COPD therapies in the 12 months post diagnosis year 1.\n\nExclusion Criteria:\n\n* Aged less than 40 years\n* No diagnosis of COPD between 1990 and 2009\n* Less than three years continuous practice data including two years prior to and one year post diagnosis\n* Less than two prescriptions for COPD therapies in the 12 months post diagnosis year 1.'}, 'identificationModule': {'nctId': 'NCT01655667', 'briefTitle': 'Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis', 'organization': {'class': 'NETWORK', 'fullName': 'Research in Real-Life Ltd'}, 'officialTitle': 'Improving Diagnosis of COPD Through Characterisation of Comorbidities Present at, and Healthcare Utilisation Prior to, Diagnosis of COPD in UK. A Retrospective Primary Care Database.', 'orgStudyIdInfo': {'id': '015/11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Obstructive Pulmonary Disease', 'description': 'All patients with a coded diagnosis of COPD entered into their electronic clinical record between 1990 and 2009.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB24 3BA', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Research in Real Life Ltd', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'David B Price, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research in Real-Life Ltd'}, {'name': 'Dermot Ryan, MBBS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Edinburgh'}, {'name': 'Rupert Jones, MBBS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peninsula College of Medinicne and Dentistry'}, {'name': 'Eric Bateman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Cape Town'}, {'name': 'Matt Kearney, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Health, United Kingdom'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research in Real-Life Ltd', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Department of Health, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor David Price', 'investigatorFullName': 'Shuna Gould', 'investigatorAffiliation': 'Research in Real-Life Ltd'}}}}