Comprehensive Disease Management Program in COPD Patients in the Community: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sheba Medical Center
- Enrollment
- 1,202
- Locations
- 2
- Primary Endpoint
- Hospital admission for acute exacerbation of COPD or all-cause mortality
Study Overview
Brief Summary
The purpose of this study is to determine whether comprehensive disease management program combined with best care recommended in clinical guidelines, is more effective than best care alone in patients with advanced chronic obstructive pulmonary disease (COPD).
Detailed Description
The study objective is to evaluate the effectiveness of a comprehensive program among patients with advanced COPD, implemented by a multi-disciplinary team. The program consists of best care recommended in clinical guidelines, combined with disease management, compared to best care only.
The program will include designated COPD centers operated by multi-disciplinary teams (pulmonologists, nurse practitioners, physiotherapists, social workers and dietitians). Disease management will be provided in these centers by qualified designated nurses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 40 years or older
- •Advanced COPD
Exclusion Criteria
- •Permanent tracheostomy
- •Heart failure with significant left-ventricular dysfunction
- •Severe other chronic disease
- •Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate
- •No telephone or permanent address
- •Refusal to use telemonitoring equipment
- •Participation in another clinical trial
Arms & Interventions
Disease management
Comprehensive disease management in addition to best care according to clinical guidelines for COPD patients
Intervention: Disease management (Other)
Best care
Best care according to clinical guidelines for COPD patients
Intervention: Best care (Other)
Outcomes
Primary Outcomes
Hospital admission for acute exacerbation of COPD or all-cause mortality
Time Frame: Within 2 to 5 years after randomization
Secondary Outcomes
- Depression(Within 2 to 5 years after randomization)
- Functional capacity(Within 2 to 5 years after randomization)
- Spirometry parameters(Within 2 to 5 years after randomization)
- Total days of hospitalization for acute exacerbations of COPD(Within 2 to 5 years after randomization)
- Total number of acute exacerbations of COPD(Within 2 to 5 years after randomization)
- Quality of life(Within 2 to 5 years after randomization)
Investigators
Ofra Kalter-Leibovici MD
Director of the Unit of Cardiovascular Epidemiology, Gertner Institute.
Sheba Medical Center