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Comprehensive Disease Management Program in Chronic Obstructive Pulmonary Disease (COPD) Patients in the Community (COPD_CDM)

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ClinicalTrials.gov Identifier: NCT00982384
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : May 20, 2015
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Ofra Kalter-Leibovici MD, Sheba Medical Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Other: Disease management Other: Best care Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comprehensive Disease Management Program in COPD Patients in the Community: Randomized Controlled Trial
Study Start Date : October 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Disease management
Comprehensive disease management in addition to best care according to clinical guidelines for COPD patients
Other: Disease management
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

Active Comparator: Best care
Best care according to clinical guidelines for COPD patients
Other: Best care
Comprehensive care for COPD patients recommended in clinical guidelines




Primary Outcome Measures :
  1. Hospital admission for acute exacerbation of COPD or all-cause mortality [ Time Frame: Within 2 to 5 years after randomization ]

Secondary Outcome Measures :
  1. Total days of hospitalization for acute exacerbations of COPD [ Time Frame: Within 2 to 5 years after randomization ]
  2. Quality of life [ Time Frame: Within 2 to 5 years after randomization ]
  3. Total number of acute exacerbations of COPD [ Time Frame: Within 2 to 5 years after randomization ]
  4. Depression [ Time Frame: Within 2 to 5 years after randomization ]
  5. Functional capacity [ Time Frame: Within 2 to 5 years after randomization ]
  6. Spirometry parameters [ Time Frame: Within 2 to 5 years after randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 40 years or older
  2. Advanced COPD

Exclusion Criteria:

  1. Permanent tracheostomy
  2. Heart failure with significant left-ventricular dysfunction
  3. Severe other chronic disease
  4. Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate
  5. No telephone or permanent address
  6. Bedridden
  7. Refusal to use telemonitoring equipment
  8. Participation in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982384


Locations
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Israel
Bat-Yam COPD Center
Bat-Yam, Israel
COPD Center, Hadera
Hadera, Israel
Sponsors and Collaborators
Sheba Medical Center
Clalit Health Services
Investigators
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Principal Investigator: Ofra Kalter - Leibovici, M.D. Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center
Study Director: Gershon Fink, M.D. Clalit Health Services

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ofra Kalter-Leibovici MD, Director of the Unit of Cardiovascular Epidemiology, Gertner Institute., Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00982384     History of Changes
Other Study ID Numbers: SHEBA-09-7120-OK-CTIL
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Ofra Kalter-Leibovici MD, Sheba Medical Center:
Chronic obstructive pulmonary disease
Disease management
Pulmonary rehabilitation
Quality of life

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases