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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Disease management
Best care
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic obstructive pulmonary disease, Disease management, Pulmonary rehabilitation, Quality of life

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bat-Yam COPD Center
  • COPD Center, Hadera

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Disease management

Best care

Arm Description

Comprehensive disease management in addition to best care according to clinical guidelines for COPD patients

Best care according to clinical guidelines for COPD patients

Outcomes

Primary Outcome Measures

Hospital admission for acute exacerbation of COPD or all-cause mortality

Secondary Outcome Measures

Total days of hospitalization for acute exacerbations of COPD
Quality of life
Total number of acute exacerbations of COPD
Depression
Functional capacity
Spirometry parameters

Full Information

First Posted
September 14, 2009
Last Updated
May 19, 2015
Sponsor
Sheba Medical Center
Collaborators
Clalit Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT00982384
Brief Title
Comprehensive Disease Management Program in Chronic Obstructive Pulmonary Disease (COPD) Patients in the Community
Acronym
COPD_CDM
Official Title
Comprehensive Disease Management Program in COPD Patients in the Community: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Clalit Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic obstructive pulmonary disease, Disease management, Pulmonary rehabilitation, Quality of life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Disease management
Arm Type
Experimental
Arm Description
Comprehensive disease management in addition to best care according to clinical guidelines for COPD patients
Arm Title
Best care
Arm Type
Active Comparator
Arm Description
Best care according to clinical guidelines for COPD patients
Intervention Type
Other
Intervention Name(s)
Disease management
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Best care
Intervention Description
Comprehensive care for COPD patients recommended in clinical guidelines
Primary Outcome Measure Information:
Title
Hospital admission for acute exacerbation of COPD or all-cause mortality
Time Frame
Within 2 to 5 years after randomization
Secondary Outcome Measure Information:
Title
Total days of hospitalization for acute exacerbations of COPD
Time Frame
Within 2 to 5 years after randomization
Title
Quality of life
Time Frame
Within 2 to 5 years after randomization
Title
Total number of acute exacerbations of COPD
Time Frame
Within 2 to 5 years after randomization
Title
Depression
Time Frame
Within 2 to 5 years after randomization
Title
Functional capacity
Time Frame
Within 2 to 5 years after randomization
Title
Spirometry parameters
Time Frame
Within 2 to 5 years after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 40 years or older Advanced COPD Exclusion Criteria: Permanent tracheostomy Heart failure with significant left-ventricular dysfunction Severe other chronic disease Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate No telephone or permanent address Bedridden Refusal to use telemonitoring equipment Participation in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofra Kalter - Leibovici, M.D.
Organizational Affiliation
Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gershon Fink, M.D.
Organizational Affiliation
Clalit Health Services
Official's Role
Study Director
Facility Information:
Facility Name
Bat-Yam COPD Center
City
Bat-Yam
Country
Israel
Facility Name
COPD Center, Hadera
City
Hadera
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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