Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— COPD_CDMOfficial title:
Comprehensive Disease Management Program in COPD Patients in the Community: Randomized Controlled Trial
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).
Status | Completed |
Enrollment | 1202 |
Est. completion date | December 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Israel | Bat-Yam COPD Center | Bat-Yam | |
Israel | COPD Center, Hadera | Hadera |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center | Clalit Health Services |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospital admission for acute exacerbation of COPD or all-cause mortality | Within 2 to 5 years after randomization | Yes | |
Secondary | Total days of hospitalization for acute exacerbations of COPD | Within 2 to 5 years after randomization | No | |
Secondary | Quality of life | Within 2 to 5 years after randomization | No | |
Secondary | Total number of acute exacerbations of COPD | Within 2 to 5 years after randomization | No | |
Secondary | Depression | Within 2 to 5 years after randomization | No | |
Secondary | Functional capacity | Within 2 to 5 years after randomization | No | |
Secondary | Spirometry parameters | Within 2 to 5 years after randomization | No |
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