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Clinical Trials/NCT01101126
NCT01101126
Terminated
Not Applicable

Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services

Sheba Medical Center1 site in 1 country492 target enrollmentMarch 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
Sheba Medical Center
Enrollment
492
Locations
1
Primary Endpoint
Healthcare services utilization for acute exacerbations of pulmonary disease
Status
Terminated
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to determine whether disease management program is effective in preventing acute exacerbations in patients with unstable chronic obstructive pulmonary disease (COPD) or asthma.

Detailed Description

The aim of the present study is to test the efficacy of a comprehensive community disease management program in patients with unstable chronic obstructive pulmonary disease (COPD) or asthma. The intervention is delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals at the community, in the Jerusalem and the Lowland District of Maccabi Health Services in Israel. The main purpose is to evaluate the effect of the intervention on the use acute care and emergency health services for acute exacerbation of the lung disease. Secondary objectives include the evaluation of the effect of the intervention on quality of life, physical function, pulmonary function test, depression and all-cause mortality.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
April 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ofra Kalter-Leibovici MD

Dr.

Sheba Medical Center

Eligibility Criteria

Inclusion Criteria

  • Men and women
  • 40 years or older
  • Having unstable COPD or Asthma

Exclusion Criteria

  • Significant LV dysfunction
  • Other severe chronic morbidity compromising short-term survival
  • Significant cognitive impairment or psychiatric disease
  • Homeless or no telephone connection

Outcomes

Primary Outcomes

Healthcare services utilization for acute exacerbations of pulmonary disease

Time Frame: Every 6 months during 1-3 years' follow-up

The proportion of patients who, due to exacerbation of their COPD or asthma, have at least one out of hours visit to a "off-hour non-hospital based acute-care facilities", or a visit to a hospital emergency room, or a hospitalization within the two years of follow-up.

Secondary Outcomes

  • Quality of life(Every 6 months during 1-3 years' follow-up)
  • Pulmonary function tests(Every 6 months during 1-3 years' follow-up)
  • Physical function(Every 6 months during 1-3 years' follow-up)
  • Depression(Every 6 months during 1-3 years' follow-up)

Study Sites (1)

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