Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis

This study has been completed.
Sponsor:
Collaborator:
Department of Health, United Kingdom
Information provided by (Responsible Party):
Shuna Gould, Research in Real-Life Ltd
ClinicalTrials.gov Identifier:
NCT01655667
First received: July 31, 2012
Last updated: August 1, 2012
Last verified: August 2012

July 31, 2012
August 1, 2012
December 2010
February 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01655667 on ClinicalTrials.gov Archive Site
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Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis
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

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

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.

Chronic Obstructive Pulmonary Disease
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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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38859
June 2012
February 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01655667
015/11
Yes
Shuna Gould, Research in Real-Life Ltd
Research in Real-Life Ltd
Department of Health, United Kingdom
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
Research in Real-Life Ltd
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP