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)

Sponsor:

Collaborator:

Maccabi Healthcare Services, Israel

Information provided by (Responsible Party):

Ofra Kalter-Leibovici MD, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT01101126

First received: April 8, 2010

Last updated: January 20, 2015

Last verified: January 2015

History of Changes

Purpose

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) Asthma	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:

MedlinePlus related topics: COPD Lung Diseases

U.S. FDA Resources

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.

Eligibility


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

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
Bedridden
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 ClinicalTrials.gov identifier: NCT01101126

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


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
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) 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

ClinicalTrials.gov processed this record on September 28, 2016

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