Comprehensive Disease Management Program in Chronic Obstructive Pulmonary Disease (COPD) Patients in the Community

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Other: Disease management; Other: Best care

• Registration Number: NCT00982384
• Lead Sponsor: Sheba Medical Center

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 Timeline

• Study First Submitted: 2009-09-14
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Study Start: 2009-10
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disease management	Disease management	Comprehensive disease management in addition to best care according to clinical guidelines for COPD patients
Best care	Best care	Best care according to clinical guidelines for COPD patients

Primary Outcome Measures

Name	Time	Method
Hospital admission for acute exacerbation of COPD or all-cause mortality	Within 2 to 5 years after randomization

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Bat-Yam COPD Center; 🇮🇱 Bat-Yam, Israel

COPD Center, Hadera; 🇮🇱 Hadera, Israel