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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01101126
Other study ID # SHEBA-10-7741-OK-CTIL
Secondary ID
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


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
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