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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
History of Changes
  Purpose

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


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Research in Real-Life Ltd:

Enrollment: 38859
Study Start Date: December 2010
Study Completion Date: June 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Obstructive Pulmonary Disease
All patients with a coded diagnosis of COPD entered into their electronic clinical record between 1990 and 2009.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655667

Locations
United Kingdom
Research in Real Life Ltd
Cambridge, Cambridgeshire, United Kingdom, CB24 3BA
Sponsors and Collaborators
Research in Real-Life Ltd
Department of Health, United Kingdom
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
  More Information

No publications provided

Responsible Party: Shuna Gould, Professor David Price, Research in Real-Life Ltd
ClinicalTrials.gov Identifier: NCT01655667     History of Changes
Other Study ID Numbers: 015/11
Study First Received: July 31, 2012
Last Updated: August 1, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Research in Real-Life Ltd:
Diagnosis
Primary Care
Comorbidities
Healthcare utilisation

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013