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Clinical Trials/NL-OMON39810
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

Medisch Spectrum Twente0 sites140 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

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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