Healt status guided COPD (March)
Completed
- Conditions
- chronic bronchitisCOPD10038716
- Registration Number
- NL-OMON32772
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 330
Inclusion Criteria
- diagnosis of COPD
- aged > 40 yrs
- smoking history > 10 pack-yrs
- FEV1/ forced vital capacity (FVC) <0.70 post-bronchodilator
Exclusion Criteria
- Myocardial infarction less than 3 months ago
- Inability to read and understand the Dutch language.
- history of asthma or allergic rhinitis before the age of 40
- regular use of oxygen
- unstable or life-threatening comorbid condition
- Dementia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Change in health status (SGRQ total score) over time.<br /><br>2. The second primary outcome will be the exacerbation frequency, measured by<br /><br>medication use. (</p><br>
- Secondary Outcome Measures
Name Time Method <p>Change in CCQ score.<br /><br>Changes in 6 minute walking distance test results.<br /><br>Changes in mMRC-score and HADS-score<br /><br>Hospital admissions.<br /><br>Death.<br /><br>Changes in lung function<br /><br>Quality adjusted life years (QALY*s)<br /><br><br /><br>The CCQ has a total score and 3 subdomain scores. Total scores and subdomain<br /><br>scores will be compared to other questionnaires that address the same factors.<br /><br>This way it can be assessed if the subdomain scores can be used as a valid<br /><br>method to diagnose problems in the different domains.<br /><br>• Total score: Total SGRQ<br /><br>• Symptom domain: SGRQ symptom domain<br /><br>• Functional domain: SGRQ section 6 and 7<br /><br>• Mental domain: Depression and anxiety scale (HADS)</p><br>