Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients

Asthma Clinical Trial

— ACDM-Maccabi  

Official title:

Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01101126
• Other study ID #: SHEBA-10-7741-OK-CTIL
• Status: Terminated
• Phase: N/A
• First received: April 8, 2010
• Last updated: January 20, 2015
• Start date: March 2010
• Est. completion date: April 2013

Study information

• Verified date: January 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 disease management program is effective in preventing acute exacerbations in patients with unstable chronic obstructive pulmonary disease (COPD) or asthma.

Description:

The aim of the present study is to test the efficacy of a comprehensive community disease management program in patients with unstable chronic obstructive pulmonary disease (COPD) or asthma. The intervention is delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals at the community, in the Jerusalem and the Lowland District of Maccabi Health Services in Israel.

The main purpose is to evaluate the effect of the intervention on the use acute care and emergency health services for acute exacerbation of the lung disease.

Secondary objectives include the evaluation of the effect of the intervention on quality of life, physical function, pulmonary function test, depression and all-cause mortality.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 492
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Men and women

2. 40 years or older

3. Having unstable COPD or Asthma

Exclusion Criteria:

1. Significant LV dysfunction

2. Other severe chronic morbidity compromising short-term survival

3. Significant cognitive impairment or psychiatric disease

4. Bedridden

5. Homeless or no telephone connection

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Pulmonary disease management
Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations
• Usual care
Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist

Locations

Country	Name	City	State
Israel	Maccabi Pulmonary Clinic	Bat-Yam
Israel	Maccabi Pulmonary Clinic	Holon

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Maccabi Healthcare Services, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare services utilization for acute exacerbations of pulmonary disease	The proportion of patients who, due to exacerbation of their COPD or asthma, have at least one out of hours visit to a "off-hour non-hospital based acute-care facilities", or a visit to a hospital emergency room, or a hospitalization within the two years of follow-up.	Every 6 months during 1-3 years' follow-up	Yes
Secondary	Quality of life	Health-related quality of life	Every 6 months during 1-3 years' follow-up	No
Secondary	Pulmonary function tests	Pulmonary function tests	Every 6 months during 1-3 years' follow-up	No
Secondary	Physical function	6-minutes walk test assessment	Every 6 months during 1-3 years' follow-up	No
Secondary	Depression	PHQ-9 Questionnaire	Every 6 months during 1-3 years' follow-up	No