Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients (ACDM-Maccabi)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	492 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Quality of life [ Time Frame: Every 6 months during 1-3 years' follow-up ]
   Health-related quality of life
2. Pulmonary function tests [ Time Frame: Every 6 months during 1-3 years' follow-up ]
   Pulmonary function tests
3. Physical function [ Time Frame: Every 6 months during 1-3 years' follow-up ]
   6-minutes walk test assessment
4. Depression [ Time Frame: Every 6 months during 1-3 years' follow-up ]
   PHQ-9 Questionnaire

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

Inclusion Criteria:

1. Men and women
2. 40 years or older
3. Having unstable COPD or Asthma

Exclusion Criteria:

1. Significant LV dysfunction
2. Other severe chronic morbidity compromising short-term survival
3. Significant cognitive impairment or psychiatric disease
4. Bedridden
5. Homeless or no telephone connection

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Israel
Maccabi Pulmonary Clinic
Bat-Yam, Israel
Maccabi Pulmonary Clinic
Holon, Israel

Sponsors and Collaborators

Sheba Medical Center

Maccabi Healthcare Services, Israel

Investigators

Principal Investigator:	Meir Raz, M.D.	Maccabi Healthcare Services, Israel
Study Director:	Ofra Kalter - Leibovici, M.D.	Sheba Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ofra Kalter-Leibovici MD, Dr., Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT01101126 History of Changes
Other Study ID Numbers:	SHEBA-10-7741-OK-CTIL
First Posted:	April 9, 2010
Last Update Posted:	January 21, 2015
Last Verified:	January 2015

Keywords provided by Ofra Kalter-Leibovici MD, Sheba Medical Center:

Chronic obstructive pulmonary disease (COPD); Asthma

Additional relevant MeSH terms:

Asthma; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchial Diseases	Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases