- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655667
Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis
August 1, 2012 updated by: Shuna Gould, Research in Real-Life Ltd
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.
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
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
38859
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB24 3BA
- Research in Real Life Ltd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Aged 40 years or older
- 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
- Recieved two or more prescriptions for COPD therapies in the 12 months post diagnosis year 1.
Exclusion Criteria:
- Aged less than 40 years
- No diagnosis of COPD between 1990 and 2009
- Less than three years continuous practice data including two years prior to and one year post diagnosis
- Less than two prescriptions for COPD therapies in the 12 months post diagnosis year 1.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David B Price, MD, Research in Real-Life Ltd
- Study Director: Dermot Ryan, MBBS, University of Edinburgh
- Study Director: Rupert Jones, MBBS, Peninsula College of Medinicne and Dentistry
- Study Director: Eric Bateman, MD, University of Cape Town
- Study Director: Matt Kearney, MPH, Department of Health, United Kingdom
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
July 31, 2012
First Submitted That Met QC Criteria
August 1, 2012
First Posted (Estimate)
August 2, 2012
Study Record Updates
Last Update Posted (Estimate)
August 2, 2012
Last Update Submitted That Met QC Criteria
August 1, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 015/11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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