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

May 19, 2015 updated by: Ofra Kalter-Leibovici MD, Sheba Medical Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Within 2 to 5 years after randomization
Within 2 to 5 years after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Total days of hospitalization for acute exacerbations of COPD
Time Frame: Within 2 to 5 years after randomization
Within 2 to 5 years after randomization
Quality of life
Time Frame: Within 2 to 5 years after randomization
Within 2 to 5 years after randomization
Total number of acute exacerbations of COPD
Time Frame: Within 2 to 5 years after randomization
Within 2 to 5 years after randomization
Depression
Time Frame: Within 2 to 5 years after randomization
Within 2 to 5 years after randomization
Functional capacity
Time Frame: Within 2 to 5 years after randomization
Within 2 to 5 years after randomization
Spirometry parameters
Time Frame: Within 2 to 5 years after randomization
Within 2 to 5 years after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-09-7120-OK-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe