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

Sheba Medical Center

Status: Terminated

Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Other: Pulmonary disease management; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01101126

SHEBA-10-7741-OK-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 492 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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492 participants in 2 patient groups

Disease Management

Experimental group

Description:

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

Treatment:

Other: Pulmonary disease management

Unual care

Active Comparator group

Description:

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

Treatment:

Other: Usual care