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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD), Asthma

Intervention / Treatment
-----------------
* Other: Pulmonary disease management
* Other: Usual care


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disease Management<br>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<br>* Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations<br>|
| Active Comparator: Unual care<br>Care delivered by the primary practitioner with the advice of a consultant pulmonologist | Other: Usual care<br>* Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic obstructive pulmonary disease (COPD), Asthma