Chronic Obstructive Pulmonary Disease (COPD)ACDM-MaccabiNCT01101126
Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Pulmonary disease management in people with Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by Sheba Medical Center at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Asthma
- What is being tested?
- Pulmonary disease management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 2 sitesIsrael
- Study dates
- Mar 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- 40 years or older
- Having unstable COPD or Asthma
Who cannot join
- Significant LV dysfunction
- Other severe chronic morbidity compromising short-term survival
- Significant cognitive impairment or psychiatric disease
- Bedridden
- Homeless or no telephone connection
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services
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.
Read the 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.
- Being tested
- Pulmonary disease management, Usual care
- Keywords
- Chronic obstructive pulmonary disease (COPD), Asthma
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary disease managementOther
Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations
Usual careOther
Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist
| Study group | Role | What they receive |
|---|---|---|
| Disease Management | Experimental | Comprehensive care delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals in the community Receives: Other: Pulmonary disease management |
| Unual care | Active comparator | Care delivered by the primary practitioner with the advice of a consultant pulmonologist Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 6 months during 1-3 years' follow-up
Secondary outcomes (4)
Quality of life
Health-related quality of life
Measured: Every 6 months during 1-3 years' follow-up
Pulmonary function tests
Pulmonary function tests
Measured: Every 6 months during 1-3 years' follow-up
Physical function
6-minutes walk test assessment
Measured: Every 6 months during 1-3 years' follow-up
Depression
PHQ-9 Questionnaire
Measured: Every 6 months during 1-3 years' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2013
- Study completionApr 2013
Why it stopped: An excess of all-cause acute health services utilization in the intervention arm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Maccabi Healthcare Services, Israel
- Responsible party
- Principal investigator, Ofra Kalter-Leibovici MD, Sheba Medical Center
- Investigators
- Meir Raz, M.D., Principal investigator, Maccabi Healthcare Services, IsraelOfra Kalter - Leibovici, M.D., Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101126
- Sponsor's protocol ID
- SHEBA-10-7741-OK-CTIL
- Acronym
- ACDM-Maccabi
- Status last verified
- Jan 2015
- First submitted
- 8 Apr 2010
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services
- ClinicalTrials.gov ID
- NCT01101126
- Acronym / sponsor ID
- ACDM-Maccabi / SHEBA-10-7741-OK-CTIL
- Keywords
- Chronic obstructive pulmonary disease (COPD), Asthma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An excess of all-cause acute health services utilization in the intervention arm
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Maccabi Healthcare Services, Israel
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease Management | Experimental | Other: Pulmonary disease managementComprehensive care delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals in the community |
| Unual care | Active comparator | Other: Usual careCare delivered by the primary practitioner with the advice of a consultant pulmonologist |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women
- 40 years or older
- Having unstable COPD or Asthma
Key exclusion criteria (5 listed)
- Significant LV dysfunction
- Other severe chronic morbidity compromising short-term survival
- Significant cognitive impairment or psychiatric disease
- Bedridden
- Homeless or no telephone connection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary disease managementComprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations | Other | Disease Management |
| Usual carePulmonary disease is managed by the primary practitioner and a consultant pulmonologist | Other | Unual care |
Primary outcome
Healthcare services utilization for acute exacerbations of pulmonary disease
Time frame: 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.
4 secondary outcomes
Quality of life
Time frame: Every 6 months during 1-3 years' follow-up
Pulmonary function tests
Time frame: Every 6 months during 1-3 years' follow-up
Physical function
Time frame: Every 6 months during 1-3 years' follow-up
Depression
Time frame: Every 6 months during 1-3 years' follow-up
Results and safety
The study was stopped early (reason given: An excess of all-cause acute health services utilization in the intervention arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meir Raz, M.D. principal investigator
Maccabi Healthcare Services, Israel
Ofra Kalter - Leibovici, M.D. study director
Sheba Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary disease management in people with Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by Sheba Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: An excess of all-cause acute health services utilization in the intervention arm). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare services utilization for acute exacerbations of pulmonary disease (time frame: Every 6 months during 1-3 years' follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.