Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis
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| First Received Date ICMJE | July 31, 2012 | ||||||||||||||||||||
| Last Updated Date | August 1, 2012 | ||||||||||||||||||||
| Start Date ICMJE | December 2010 | ||||||||||||||||||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01655667 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis | ||||||||||||||||||||
| Official Title ICMJE | 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. | ||||||||||||||||||||
| Brief Summary | 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 |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||||||||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||||||||||
| Study Population | 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. |
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| Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||||||
| Study Group/Cohort (s) | Chronic Obstructive Pulmonary Disease
All patients with a coded diagnosis of COPD entered into their electronic clinical record between 1990 and 2009. |
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| Publications * | Not Provided | ||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||
| Enrollment ICMJE | 38859 | ||||||||||||||||||||
| Completion Date | June 2012 | ||||||||||||||||||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 40 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | United Kingdom | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT01655667 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | 015/11 | ||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||
| Responsible Party | Shuna Gould, Research in Real-Life Ltd | ||||||||||||||||||||
| Study Sponsor ICMJE | Research in Real-Life Ltd | ||||||||||||||||||||
| Collaborators ICMJE | Department of Health, United Kingdom | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Research in Real-Life Ltd | ||||||||||||||||||||
| Verification Date | August 2012 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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