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.

Repatriation General Hospital0 个研究点目标入组 300 人开始时间: 2012年5月15日最近更新: 2020年1月13日

适应症

试验速览

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•1) a clinical diagnosis of COPD according to the GOLD criteria; 2) >= 1 diagnostic comorbidity: ischaemic heart disease (history of myocardial infarction, angina pectoris); heart failure (defined according to the ESC guidelines; diabetes (stable type 1 or 2); or active symptoms of depression and/or anxiety (using cut-off scores from the Hospital Anxiety and Depression Scale (HADS); 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 6 weeks post-hospitalisation or post-rehabilitation); 6) FEV1 < 80% of the predicted value and FEV1/FVC<0.70; 7) able to understand and read the English or Dutch language; 8) 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) or any other condition which, according to expert clinical judgment of the Chief Investigator, is likely to limit 12-month survival; 3) other serious lung disease (e.g. alpha1-antitrypsin deficiency; interstitial lung diseases); 4) patients with active psychotic symptoms or suicidal ideation; 5) patients with cognitive impairment (Mini-Mental State Exam < 24); 6) patients who are currently enrolled in other clinical trials; 7) currently enrolled in other clinical trials or intensive case-management programs.

发起方

Repatriation General Hospital