Clinical trial NCT00982384: Comprehensive Disease Management Program in Chronic Obstructive Pulmonary Disease (COPD) Patients in the Community
Official title: Comprehensive Disease Management Program in COPD Patients in the Community: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease
Disease management
Pulmonary rehabilitation
Quality of life
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Clalit Health Services
First posted: 2009-09-23
Enrollment: 1202
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital admission for acute exacerbation of COPD or all-cause mortality
timeFrame: Within 2 to 5 years after randomization
Secondary outcomes:
measure: Total days of hospitalization for acute exacerbations of COPD
timeFrame: Within 2 to 5 years after randomization
measure: Quality of life
timeFrame: Within 2 to 5 years after randomization
measure: Total number of acute exacerbations of COPD
timeFrame: Within 2 to 5 years after randomization
measure: Depression
timeFrame: Within 2 to 5 years after randomization
measure: Functional capacity
timeFrame: Within 2 to 5 years after randomization
measure: Spirometry parameters
timeFrame: Within 2 to 5 years after randomization
Other outcomes:
Locations:
city: Bat-Yam
country: Israel
facility: Bat-Yam COPD Center
city: Hadera
country: Israel
facility: COPD Center, Hadera
Study officials:
affiliation: Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center
name: Ofra Kalter - Leibovici, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: Gershon Fink, M.D.
role: STUDY_DIRECTOR
References: