Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients (ACDM-Maccabi)
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|ClinicalTrials.gov Identifier: NCT01101126|
Recruitment Status : Terminated (An excess of all-cause acute health services utilization in the intervention arm)
First Posted : April 9, 2010
Last Update Posted : January 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD) Asthma||Other: Pulmonary disease management Other: Usual care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||492 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||April 2013|
Experimental: Disease Management
Comprehensive care delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals in the community
Other: Pulmonary disease management
Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations
Active Comparator: Unual care
Care delivered by the primary practitioner with the advice of a consultant pulmonologist
Other: Usual care
Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist
- 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.
- Quality of life [ Time Frame: Every 6 months during 1-3 years' follow-up ]Health-related quality of life
- Pulmonary function tests [ Time Frame: Every 6 months during 1-3 years' follow-up ]Pulmonary function tests
- Physical function [ Time Frame: Every 6 months during 1-3 years' follow-up ]6-minutes walk test assessment
- Depression [ Time Frame: Every 6 months during 1-3 years' follow-up ]PHQ-9 Questionnaire
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): NCT01101126
|Maccabi Pulmonary Clinic|
|Maccabi Pulmonary Clinic|
|Principal Investigator:||Meir Raz, M.D.||Maccabi Healthcare Services, Israel|
|Study Director:||Ofra Kalter - Leibovici, M.D.||Sheba Medical Center|