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| Name | Class |
|---|---|
| Clalit Health Services | OTHER |
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The purpose of this study is to determine whether comprehensive disease management program combined with best care recommended in clinical guidelines, is more effective than best care alone in patients with advanced chronic obstructive pulmonary disease (COPD).
The study objective is to evaluate the effectiveness of a comprehensive program among patients with advanced COPD, implemented by a multi-disciplinary team. The program consists of best care recommended in clinical guidelines, combined with disease management, compared to best care only.
The program will include designated COPD centers operated by multi-disciplinary teams (pulmonologists, nurse practitioners, physiotherapists, social workers and dietitians). Disease management will be provided in these centers by qualified designated nurses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disease management | Experimental | Comprehensive disease management in addition to best care according to clinical guidelines for COPD patients |
|
| Best care | Active Comparator | Best care according to clinical guidelines for COPD patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disease management | Other | Disease management by COPD nurses, including active follow-up and coordination of care in addition to best care according to clinical guidelines for COPD patients |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital admission for acute exacerbation of COPD or all-cause mortality | Within 2 to 5 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Total days of hospitalization for acute exacerbations of COPD | Within 2 to 5 years after randomization | |
| Quality of life | Within 2 to 5 years after randomization | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ofra Kalter - Leibovici, M.D. | Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center | Principal Investigator |
| Gershon Fink, M.D. | Clalit Health Services | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bat-Yam COPD Center | Bat Yam | Israel | ||||
| COPD Center, Hadera |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D019468 | Disease Management |
| ID | Term |
|---|---|
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Best care | Other | Comprehensive care for COPD patients recommended in clinical guidelines |
|
| Total number of acute exacerbations of COPD |
| Within 2 to 5 years after randomization |
| Depression | Within 2 to 5 years after randomization |
| Functional capacity | Within 2 to 5 years after randomization |
| Spirometry parameters | Within 2 to 5 years after randomization |
| Hadera |
| Israel |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |