Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients (ACDM-Maccabi)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD), Asthma
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pulmonary disease management
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic obstructive pulmonary disease (COPD), Asthma
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
Sites / Locations
- Maccabi Pulmonary Clinic
- Maccabi Pulmonary Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Disease Management
Unual care
Arm Description
Comprehensive care delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals in the community
Care delivered by the primary practitioner with the advice of a consultant pulmonologist
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of life
Health-related quality of life
Pulmonary function tests
Pulmonary function tests
Physical function
6-minutes walk test assessment
Depression
PHQ-9 Questionnaire
Full Information
NCT ID
NCT01101126
First Posted
April 8, 2010
Last Updated
January 20, 2015
Sponsor
Sheba Medical Center
Collaborators
Maccabi Healthcare Services, Israel
1. Study Identification
Unique Protocol Identification Number
NCT01101126
Brief Title
Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients
Acronym
ACDM-Maccabi
Official Title
Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
An excess of all-cause acute health services utilization in the intervention arm
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Maccabi Healthcare Services, Israel
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD), Asthma
Keywords
Chronic obstructive pulmonary disease (COPD), Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
492 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Disease Management
Arm Type
Experimental
Arm Description
Comprehensive care delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals in the community
Arm Title
Unual care
Arm Type
Active Comparator
Arm Description
Care delivered by the primary practitioner with the advice of a consultant pulmonologist
Intervention Type
Other
Intervention Name(s)
Pulmonary disease management
Intervention Description
Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist
Primary Outcome Measure Information:
Title
Healthcare services utilization for acute exacerbations of pulmonary disease
Description
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.
Time Frame
Every 6 months during 1-3 years' follow-up
Secondary Outcome Measure Information:
Title
Quality of life
Description
Health-related quality of life
Time Frame
Every 6 months during 1-3 years' follow-up
Title
Pulmonary function tests
Description
Pulmonary function tests
Time Frame
Every 6 months during 1-3 years' follow-up
Title
Physical function
Description
6-minutes walk test assessment
Time Frame
Every 6 months during 1-3 years' follow-up
Title
Depression
Description
PHQ-9 Questionnaire
Time Frame
Every 6 months during 1-3 years' follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meir Raz, M.D.
Organizational Affiliation
Maccabi Healthcare Services, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ofra Kalter - Leibovici, M.D.
Organizational Affiliation
Sheba Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Maccabi Pulmonary Clinic
City
Bat-Yam
Country
Israel
Facility Name
Maccabi Pulmonary Clinic
City
Holon
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients
We'll reach out to this number within 24 hrs