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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— COPD_CDM  

Official title:

Comprehensive Disease Management Program in COPD Patients in the Community: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982384
• Other study ID #: SHEBA-09-7120-OK-CTIL
• Status: Completed
• Phase: N/A
• First received: September 14, 2009
• Last updated: May 19, 2015
• Start date: October 2009
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1202
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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
• Best care
Comprehensive care for COPD patients recommended in clinical guidelines

Locations

Country	Name	City	State
Israel	Bat-Yam COPD Center	Bat-Yam
Israel	COPD Center, Hadera	Hadera

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital admission for acute exacerbation of COPD or all-cause mortality		Within 2 to 5 years after randomization	Yes
Secondary	Total days of hospitalization for acute exacerbations of COPD		Within 2 to 5 years after randomization	No
Secondary	Quality of life		Within 2 to 5 years after randomization	No
Secondary	Total number of acute exacerbations of COPD		Within 2 to 5 years after randomization	No
Secondary	Depression		Within 2 to 5 years after randomization	No
Secondary	Functional capacity		Within 2 to 5 years after randomization	No
Secondary	Spirometry parameters		Within 2 to 5 years after randomization	No