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

Sponsor

Sheba Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT01101126

Collaborator

Maccabi Healthcare Services, Israel (Other)

492

Enrollment

Locations

Arms

Duration (Months)

246

Patients Per Site

6.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Mar 1, 2010

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

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

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

Primary Outcome Measures

Healthcare services utilization for acute exacerbations of pulmonary disease [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Bedridden
Homeless or no telephone connection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maccabi Pulmonary Clinic	Bat-Yam		Israel
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ofra Kalter-Leibovici MD, Dr., Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT01101126

Other Study ID Numbers:

SHEBA-10-7741-OK-CTIL

First Posted:

Apr 9, 2010

Last Update Posted:

Jan 21, 2015

Last Verified:

Jan 1, 2015

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

Chronic obstructive pulmonary disease (COPD)

Asthma

Additional relevant MeSH terms:

Asthma

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jan 21, 2015