Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effects of Discharge Coordinator Intervention on Hospitalizations and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Clinical Trial
This is a single-centre randomized controlled clinical trial which will enroll COPD patients in Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV, hospitalized due to acute exacerbation. Patients will be randomised in a 1:1 fashion to intervention group, which will have care organized by discharge coordinator, and control group which will receive care as usual. The primary endpoint of this study is time to hospitalization due to COPD worsening. Data will be collected at baseline, at the time of hospital discharge, and at following time-points after the hospital discharge: 48 hours, 7-10 days, 30 days, 90 days, and 180 days.
This is a single-centre randomized controlled clinical trial to assess the effectiveness of
discharge coordinator intervention compared to care as usual in patients with COPD.
The study is being conducted at University Clinic of Pulmonary and Allergic Diseases Golnik,
Slovenia. Patients with suspicion of acute exacerbation of COPD will be screened at
admission when they will be informed about study details. After explanations of concerns and
questions that they might have, a signed informed consent will be collected. During 48
hours, patients will be included according to their eligibility. Main inclusion criteria are
COPD stage II-IV according to Global Initiative for Chronic Obstructive Lung Disease (GOLD)
guidelines, ability to perform phone contacts and availability for home visits. Patients
will be excluded if in unstable or terminal stage of disease other than COPD, if they will
die during hospitalization, or if unable to follow the study protocol.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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