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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Other: Disease management; Other: Best care

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 Type: Interventional
• Enrollment (Actual): 1202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Bat-Yam, Israel
    • Bat-Yam COPD Center
  • Hadera, Israel
    • COPD Center, Hadera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disease management; Comprehensive disease management in addition to best care according to clinical guidelines for COPD patients	Other: Disease 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
Active Comparator: Best care; Best care according to clinical guidelines for COPD patients	Other: Best care; Comprehensive care for COPD patients recommended in clinical guidelines

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Total days of hospitalization for acute exacerbations of COPD	Within 2 to 5 years after randomization
Quality of life	Within 2 to 5 years after randomization
Total number of acute exacerbations of COPD	Within 2 to 5 years after randomization
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

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Clalit Health Services
• Investigators: Principal Investigator: Ofra Kalter - Leibovici, M.D., Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center; Study Director: Gershon Fink, M.D., Clalit Health Services

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 14, 2009
• First Submitted That Met QC Criteria: September 22, 2009
• First Posted (Estimate): September 23, 2009

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Quality of life; Chronic obstructive pulmonary disease; Pulmonary rehabilitation; Disease management
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SHEBA-09-7120-OK-CTIL