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Clinical Trials/ACTRN12612000514808
ACTRN12612000514808
Completed
未知

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 sites300 target enrollmentMay 15, 2012

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Repatriation General Hospital
Enrollment
300
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 15, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Repatriation General Hospital

Eligibility Criteria

Inclusion Criteria

  • 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.

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) 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.

Outcomes

Primary Outcomes

Not specified

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