Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis

Chronic Obstructive Pulmonary Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655667
• Other study ID #: 015/11
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: August 1, 2012
• Start date: December 2010
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38859
• Est. completion date: June 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Research in Real Life Ltd	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	Department of Health, United Kingdom

Country where clinical trial is conducted

United Kingdom,