NL-OMON39810
Completed
Not Applicable
The effects of self-treatment on duration of exacerbations, health status and costs of health care in patients with Chronic Obstructive Pulmonary Disease (COPD) and common co-morbidities. - COPE-III
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Medisch Spectrum Twente
- Enrollment
- 140
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) a clinical diagnosis of COPD according to the GOLD criteria (FEV1 \< 80% of the predicted value and FEV1/FVC\<0\.70\);
- •2\) \>\= 1 diagnostic comorbidity: ischaemic heart disease (history of myocardial infarction, angina pectoris (stable or unstable); heart failure (defined according to the ESC guidelines); diabetes (steroid\-induced or stable diabetes type 1 or 2\); or active symptoms of depression and/or anxiety (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 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; and/or Modified MRC (mMRC) score of 3 or 4;
- •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 Dutch language;
- •7\) written informed consent from the subject prior to participation.
Exclusion Criteria
- •1\) terminal cancer or other serious disease with low survival rate;
- •2\) end stage COPD or Chronic Heart Failure (expected survival \< 12 months);
- •3\) other serious lung disease (e.g. a1\-antitrypsin deficiency; interstitial lung diseases);
- •4\) patients who are currently enrolled in other randomised clinical trials.
- •5\) Mini Mental State Examination score \< 24
Outcomes
Primary Outcomes
Not specified
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