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

Not Applicable

Terminated

• Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Other: Pulmonary disease management; Other: Usual care

• Registration Number: NCT01101126
• Lead Sponsor: Sheba Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 492

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disease Management	Pulmonary disease management	Comprehensive care delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals in the community
Unual care	Usual care	Care delivered by the primary practitioner with the advice of a consultant pulmonologist

Primary Outcome Measures

Name	Time	Method
Healthcare services utilization for acute exacerbations of pulmonary disease	Every 6 months during 1-3 years' follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life	Every 6 months during 1-3 years' follow-up	Health-related quality of life
Pulmonary function tests	Every 6 months during 1-3 years' follow-up	Pulmonary function tests
Physical function	Every 6 months during 1-3 years' follow-up	6-minutes walk test assessment
Depression	Every 6 months during 1-3 years' follow-up	PHQ-9 Questionnaire

Trial Locations

Locations (1)

Maccabi Pulmonary Clinic; 🇮🇱 Holon, Israel