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.
Status | Completed |
Enrollment | 253 |
Est. completion date | June 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years and older |
Eligibility |
Inclusion Criteria: - age >35 years - acute exacerbation of COPD stage II-IV - residence in the geographical area linked to the study hospital - ability to communicate - give written informed consent Exclusion Criteria: - diagnosis of cognitive impairment - unstable or terminal disease other than COPD - withdrawal of written informed consent before discharge - inability of phone contact - death during hospitalisation |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Slovenia | University Clinic Golnik | Golnik |
Lead Sponsor | Collaborator |
---|---|
The University Clinic of Pulmonary and Allergic Diseases Golnik |
Slovenia,
Farkas J, Kadivec S, Kosnik M, Lainscak M. Effectiveness of discharge-coordinator intervention in patients with chronic obstructive pulmonary disease: study protocol of a randomized controlled clinical trial. Respir Med. 2011 Oct;105 Suppl 1:S26-30. doi: 10.1016/S0954-6111(11)70007-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients hospitalized due to COPD worsening | A hospitalization is defined as an unplanned overnight stay in hospital (different date for admission and discharge) due to acute worsening of COPD. Endpoint will be adjudicated by Endpoint committee. | 180 days | No |
Secondary | All-cause mortality | Mortality will be ascertained at the Central Population Registry. | 180 days | No |
Secondary | Acute exacerbations of COPD | Endpoint will be adjudicated by Endpoint committee. | 180 days | No |
Secondary | Time to hospitalization due to COPD worsening | A hospitalization is defined as an unplanned overnight stay in hospital (different date for admission and discharge) due to acute worsening of COPD. Endpoint will be adjudicated by Endpoint committee. | 180 days | No |
Secondary | Days alive and out of hospital | Endpoint will be adjudicated by Endpoint committee. | 180 days | No |
Secondary | Health-related quality of life | Endpoint will be adjudicated by Endpoint committee. | 180 days | No |
Secondary | Health care costs | Endpoint will be adjudicated by Endpoint committee. | 180 days | No |
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