Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Sheba Medical Center
- Enrollment
- 492
- Locations
- 2
- Primary Endpoint
- Healthcare services utilization for acute exacerbations of pulmonary disease
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Homeless or no telephone connection
Outcomes
Primary Outcomes
Healthcare services utilization for acute exacerbations of pulmonary disease
Time Frame: 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 Outcomes
- Quality of life(Every 6 months during 1-3 years' follow-up)
- Pulmonary function tests(Every 6 months during 1-3 years' follow-up)
- Physical function(Every 6 months during 1-3 years' follow-up)
- Depression(Every 6 months during 1-3 years' follow-up)
Investigators
Ofra Kalter-Leibovici MD
Dr.
Sheba Medical Center