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.

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Obstructive Airway Disease; 10006436

• Registration Number: NL-OMON39810
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 140

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the number of COPD exacerbation days (daily<br /><br>symptom diary). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are health status (spirometry (FEV1, FVC);<br /><br>Health-Related Quality of Life (SF-12, Chronic Respiratory Questionnaire);<br /><br>subjective fatigue (Fatigue Score); anxiety and depression symptoms (HADS)),<br /><br>confidence and competence (COPD Self-Efficacy Scale); adherence of patients<br /><br>with self-treatment protocol (daily symptom diary); satisfaction and confidence<br /><br>of health care providers (semi-structured interviews) and patients<br /><br>(focusgroups); and cost data (cost-effectiveness analysis). </p><br>