Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic obstructive pulmonary disease, Disease management, Pulmonary rehabilitation, Quality of life
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.
Interventions
OTHERDisease management
Disease management by COPD nurses, including active follow-up and coordination of care in addition to best care according to clinical guidelines for COPD patients
OTHERBest care
Comprehensive care for COPD patients recommended in clinical guidelines
Sponsors
Clalit Health Services
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 40 years or older 2. Advanced COPD
Exclusion criteria
1. Permanent tracheostomy 2. Heart failure with significant left-ventricular dysfunction 3. Severe other chronic disease 4. Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate 5. No telephone or permanent address 6. Bedridden 7. Refusal to use telemonitoring equipment 8. Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital admission for acute exacerbation of COPD or all-cause mortality | Within 2 to 5 years after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Depression | 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 |
| Functional capacity | Within 2 to 5 years after randomization |
| Spirometry parameters | Within 2 to 5 years after randomization |
| Quality of life | Within 2 to 5 years after randomization |
Countries
Israel
Outcome results
None listed