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

NCT ID: NCT01101126

Last Updated: 2015-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease (COPD) Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Disease Management

Comprehensive care delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals in the community

Group Type EXPERIMENTAL

Pulmonary disease management

Intervention Type OTHER

Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations

Unual care

Care delivered by the primary practitioner with the advice of a consultant pulmonologist

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist

Interventions

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Pulmonary disease management

Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations

Intervention Type OTHER

Usual care

Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maccabi Healthcare Services, Israel

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ofra Kalter-Leibovici MD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meir Raz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Maccabi Healthcare Services, Israel

Ofra Kalter - Leibovici, M.D.

Role: STUDY_DIRECTOR

Sheba Medical Center

Locations

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Maccabi Pulmonary Clinic

Bat Yam, , Israel

Site Status

Maccabi Pulmonary Clinic

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-10-7741-OK-CTIL

Identifier Type: -

Identifier Source: org_study_id

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