4.3. Inclusion criteria
Recruitment has started in June 2012 and is expected to conclude in June 2014. Researchers and the study physicians will review the eligibility of all patients. Eligible patients need to meet the following inclusion criteria:
(1) a clinical diagnosis of COPD according to the GOLD
criteria (FEV1 b 80% of the predicted value and
FEV1/FVC b 0.70);
(2) ≥1 diagnostic comorbidity from the following list,
selected because of their prevalence, potential for having similar symptoms as COPD exacerbations or potential to become unstable if COPD exacerbations are treated : ischaemic heart disease (history of myocardial infarction, angina pectoris), heart failure (defined according to the ESC guidelines), diabetes (steroid-induced or stable diabetes type 1 or 2); or active symptoms of anxiety and/or depression (AD) (using a cut-off score of ≥11 from the Hospital Anxiety and Depression Scale) (HADS) and/or having AD symptoms that are currently being treated;
(3) ≥3 COPD exacerbations, defined as respiratory problems that required a course of oral corticosteroids/antibiotics in the two years preceding study entry; and/or ≥1 hospitalisation for respiratory problems in the two years preceding study entry;
(4) ≥40 years of age;
(5) stable at the time of inclusion (at least 4 weeks
post-exacerbation, 6 weeks post-hospitalisation or
post-rehabilitation);
(6) able to understand and read the English or Dutch
language.