Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(An excess of all-cause acute health services utilization in the intervention arm)
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
Ofra Kalter-Leibovici MD, Sheba Medical Center Identifier:
First received: April 8, 2010
Last updated: January 20, 2015
Last verified: January 2015

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 Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Other: Pulmonary disease management
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Healthcare services utilization for acute exacerbations of pulmonary disease [ Time Frame: Every 6 months during 1-3 years' follow-up ] [ Designated as safety issue: Yes ]
    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:
  • Quality of life [ Time Frame: Every 6 months during 1-3 years' follow-up ] [ Designated as safety issue: No ]
    Health-related quality of life

  • Pulmonary function tests [ Time Frame: Every 6 months during 1-3 years' follow-up ] [ Designated as safety issue: No ]
    Pulmonary function tests

  • Physical function [ Time Frame: Every 6 months during 1-3 years' follow-up ] [ Designated as safety issue: No ]
    6-minutes walk test assessment

  • Depression [ Time Frame: Every 6 months during 1-3 years' follow-up ] [ Designated as safety issue: No ]
    PHQ-9 Questionnaire

Enrollment: 492
Study Start Date: March 2010
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01101126

Maccabi Pulmonary Clinic
Bat-Yam, Israel
Maccabi Pulmonary Clinic
Holon, Israel
Sponsors and Collaborators
Sheba Medical Center
Maccabi Healthcare Services, Israel
Principal Investigator: Meir Raz, M.D. Maccabi Healthcare Services, Israel
Study Director: Ofra Kalter - Leibovici, M.D. Sheba Medical Center
  More Information

No publications provided

Responsible Party: Ofra Kalter-Leibovici MD, Dr., Sheba Medical Center Identifier: NCT01101126     History of Changes
Other Study ID Numbers: SHEBA-10-7741-OK-CTIL
Study First Received: April 8, 2010
Last Updated: January 20, 2015
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Chronic obstructive pulmonary disease (COPD)

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases processed this record on February 26, 2015