Systematic development and validation of an exacerbation risk index for COPD patients in general practice: tailoring treatment to an individual*s needs
- Conditions
- Experts currently see COPD as a systemic illness, not just as a pulmonary illnesschronic bronchitislung emphysema10024967
- Registration Number
- NL-OMON32202
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
Patients *40 years of age with COPD in GOLD stage II to IV (postbronchodilator FEV1/FVC*0.70, postbronchodilator FEV1*80% predicted are eligible if in- or outpatient treatment of their last exacerbation ended *4 weeks ago. If patients had an exacerbation in the previous 4 weeks, (s)he can be invited when free of exacerbations for at least 4 weeks. We will include any patient who is able to complete the baseline assessment.
We will exclude patients who received mechanical ventilation in the previous 12 months because of their extremely poor prognosis and patients with co-morbidities associated with a life expectancy of *12 months. We will also exclude patients diagnosed with dementia, psychosis or other psychiatric illness that invalidate assessment of patient-reported parameters (health-related quality of life, physical activity, dyspnea etc). Finally, we will exclude patients if the baseline assessment including the questionnaires cannot be completed due to language difficulties.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Exacerbations and health-related quality of life</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>