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

Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services

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.

Study Overview

• Status: Terminated
• Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Other: Pulmonary disease management; Other: Usual care

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 Type: Interventional
• Enrollment (Actual): 492
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare services utilization for acute exacerbations of pulmonary disease	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.	Every 6 months during 1-3 years' follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: 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 record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 20, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Asthma; Chronic obstructive pulmonary disease (COPD)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma
• Other Study ID Numbers: SHEBA-10-7741-OK-CTIL