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

Medisch Spectrum Twente0 个研究点目标入组 140 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•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.

•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

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