Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients (ACDM-Maccabi)
This study is currently recruiting participants.
Verified January 2013 by Sheba Medical Center
Sponsor:
Sheba Medical Center
Collaborator:
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
Ofra Kalter-Leibovici MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01101126
First received: April 8, 2010
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Asthma |
Other: Pulmonary disease management Other: Usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services |
Resource links provided by NLM:
Further study details as provided by Sheba Medical Center:
Primary Outcome Measures:
- Healthcare services utilization for acute exacerbations of pulmonary disease [ Time Frame: Every 6 months during 1-3 years' follow-up ] [ Designated as safety issue: Yes ]The proportion of participants referred to emergency care or hospitalized because of an acute exacerbation of the pulmonary disease within the first year of follow-up
Secondary Outcome Measures:
- Quality of life [ Time Frame: Every 6 months during 1-3 years' follow-up ] [ Designated as safety issue: No ]Health-related quality of life
- Pulmonary function tests [ Time Frame: Every 6 months during 1-3 years' follow-up ] [ Designated as safety issue: No ]Pulmonary function tests
- Physical function [ Time Frame: Every 6 months during 1-3 years' follow-up ] [ Designated as safety issue: No ]6-minutes walk test assessment
- Depression [ Time Frame: Every 6 months during 1-3 years' follow-up ] [ Designated as safety issue: No ]PHQ-9 Questionnaire
| Estimated Enrollment: | 600 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Disease Management
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
Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations
|
|
Active Comparator: Unual care
Care delivered by the primary practitioner with the advice of a consultant pulmonologist
|
Other: Usual care
Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist
|
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women
- 40 years or older
- Having unstable COPD or Asthma
Exclusion Criteria:
- Significant LV dysfunction
- Other severe chronic morbidity compromising short-term survival
- Significant cognitive impairment or psychiatric disease
- Bedridden
- Homeless or no telephone connection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101126
Contacts
| Contact: Ofra Kalter-Leibovici, M.D. | +972-3-530-3247 | OfraL@gertner.health.gov.il |
| Contact: Michal Benderly, PhD | +972-3-530-3261 | MichalB@gertner.health.gov.il |
Locations
| Israel | |
| Maccabi Pulmonary Clinic | Recruiting |
| Bat-Yam, Israel | |
| Contact: Meir Raz, M.D. 972-50-8800402 raz_meir@mac.org.il | |
| Principal Investigator: Meir Raz, M.D. | |
| Maccabi Pulmonary Clinic | Active, not recruiting |
| Holon, Israel | |
Sponsors and Collaborators
Sheba Medical Center
Maccabi Healthcare Services, Israel
Investigators
| Principal Investigator: | Meir Raz, M.D. | Maccabi Healthcare Services, Israel |
| Study Director: | Ofra Kalter - Leibovici, M.D. | Sheba Medical Center |
More Information
No publications provided
| Responsible Party: | Ofra Kalter-Leibovici MD, Dr., Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT01101126 History of Changes |
| Other Study ID Numbers: | SHEBA-10-7741-OK-CTIL |
| Study First Received: | April 8, 2010 |
| Last Updated: | January 30, 2013 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
Chronic obstructive pulmonary disease (COPD) Asthma |
Additional relevant MeSH terms:
|
Asthma Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchial Diseases |
Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013