Chronic Bronchitis Chronic lung disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis of COPD based on post-bronchodilatator FEV1 according to the GOLD standards (=NHG standard). - Diagnosis of COPD as the major functionally limiting disease. - Current use of bronchodilator therapy.
Exclusion criteria
Exclusion criteria: - Primary diagnosis of asthma (onset = 12 % postbronchodilator reversibility in FEV1) - Primary diagnosis of cardiac disease - Primary diagnosis of other functionally limiting disease, that could significantly affect either patient mortality (e.g. malignant neoplasm) or participation in the study (e.g. confusional states, psychoses)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - (Clinical COPD Questionnaire) CCQ Symptom recovery time in the event of an exacerbation; number of 3 day CCQ units for the CCQ symptom score to have recovered from the exacerbation onset to the pre-exacerbation 3 unit average. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Treatmet delay (Number of days between exacerbation onset and initiation of treatment; course of antibiotics and/or prednison) - Contact delay (Number of days between exacerbation onset and contacting a health care provider - Health related quality of life I (St.George Respiratory Questionnaire) - Health related quality of life II (number of unfavourable days in 6 months that the Clinical COPD Questionnaire (CCQ) score is >= the individual mean minus 1 standard deviation) - Anxiety (Hospital Anxiety and Depression Scale) - Depression (Hospital Anxiety and Depression Scale) - Symptoms (Medical Research Counsil scale for dyspnea) - Self-efficacy ( exacerbation-related self-efficacy using a self-developped 9-item questionnaire with a 5 point-likert scale. - Healthcare utilization: * time to first respiratory related hospital admissions; number of days between inclusion and first hospital admission * number of respiratory related hospital admissions * proportion of patients having >= 1 respiratory related hospital admission * number of respiratory related hospital days * number of respiratory related emergency room visits (incl. ambulance calls) * number of respiratory related scheduled visits to GP, RN and RP. * number of respiratory related unscheduled visits to GP, RN and RP. * number of telephone calls to GP, RN and RP. * number of courses of oral steroids and/or antibiotics | — |
Countries
Netherlands