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

NCT01101126 | Terminated DMC

• 1 other identifier: SHEBA-10-7741-OK-CTIL
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Asthma

Keywords

Chronic obstructive pulmonary disease (COPD); Asthma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Quality of life

  Every 6 months during 1-3 years' follow-up

• Pulmonary function tests

  Every 6 months during 1-3 years' follow-up

• Physical function

  Every 6 months during 1-3 years' follow-up

• Depression

  Every 6 months during 1-3 years' follow-up

Study Arms (2)

Disease Management

EXPERIMENTAL

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

Other: Pulmonary disease management

Unual care

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

Pulmonary disease management OTHER

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

Disease Management

Usual care OTHER

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

Unual care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• years or older
• Having unstable COPD or Asthma

You may not qualify if:

• Significant LV dysfunction
• Other severe chronic morbidity compromising short-term survival
• Significant cognitive impairment or psychiatric disease
• Bedridden
• Homeless or no telephone connection

Sponsors & Collaborators

• Sheba Medical Center: lead
• Maccabi Healthcare Services, Israel: collaborator

Study Sites (2)

Maccabi Pulmonary Clinic

Bat Yam, Israel

Location

Maccabi Pulmonary Clinic

Holon, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Meir Raz, M.D.

  Maccabi Healthcare Services, Israel

  PRINCIPAL INVESTIGATOR

• Ofra Kalter - Leibovici, M.D.

  Sheba Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 9, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

IL (2)