Chronic Obstructive Pulmonary Disease (COPD)COPD_CDMNCT00982384
Comprehensive Disease Management Program in Chronic Obstructive Pulmonary Disease (COPD) Patients in the Community
A study testing Disease management and Best care in people with Chronic Obstructive Pulmonary Disease (COPD), run by Sheba Medical Center at 2 sites in Israel.
Trial summary
The purpose of this study is to determine whether comprehensive disease management program combined with best care recommended in clinical guidelines, is more effective than best care alone in patients with advanced chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Disease management and Best care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,202 participants
- Where
- 2 sitesIsrael
- Study dates
- Oct 2009to Dec 2014
- 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
- Age 40 years or older
- Advanced COPD
Who cannot join
- Permanent tracheostomy
- Heart failure with significant left-ventricular dysfunction
- Severe other chronic disease
- Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate
- No telephone or permanent address
- Bedridden
- Refusal to use telemonitoring equipment
- Participation in another clinical trial
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Comprehensive Disease Management Program in COPD Patients in the Community: Randomized Controlled Trial
The purpose of this study is to determine whether comprehensive disease management program combined with best care recommended in clinical guidelines, is more effective than best care alone in patients with advanced chronic obstructive pulmonary disease (COPD).
Read the detailed description
The study objective is to evaluate the effectiveness of a comprehensive program among patients with advanced COPD, implemented by a multi-disciplinary team. The program consists of best care recommended in clinical guidelines, combined with disease management, compared to best care only.
The program will include designated COPD centers operated by multi-disciplinary teams (pulmonologists, nurse practitioners, physiotherapists, social workers and dietitians). Disease management will be provided in these centers by qualified designated nurses.
- Being tested
- Disease management, Best care
- Keywords
- Chronic obstructive pulmonary disease, Disease management, Pulmonary rehabilitation, Quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease managementOther
Disease management by COPD nurses, including active follow-up and coordination of care in addition to best care according to clinical guidelines for COPD patients
Best careOther
Comprehensive care for COPD patients recommended in clinical guidelines
| Study group | Role | What they receive |
|---|---|---|
| Disease management | Experimental | Comprehensive disease management in addition to best care according to clinical guidelines for COPD patients Receives: Other: Disease management |
| Best care | Active comparator | Best care according to clinical guidelines for COPD patients Receives: Other: Best care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admission for acute exacerbation of COPD or all-cause mortality
Measured: Within 2 to 5 years after randomization
Secondary outcomes (6)
Total days of hospitalization for acute exacerbations of COPD
Measured: Within 2 to 5 years after randomization
Quality of life
Measured: Within 2 to 5 years after randomization
Total number of acute exacerbations of COPD
Measured: Within 2 to 5 years after randomization
Depression
Measured: Within 2 to 5 years after randomization
Functional capacity
Measured: Within 2 to 5 years after randomization
Spirometry parameters
Measured: Within 2 to 5 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2014
- Study completionDec 2014
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Clalit Health Services
- Responsible party
- Principal investigator, Ofra Kalter-Leibovici MD, Sheba Medical Center
- Investigators
- Ofra Kalter - Leibovici, M.D., Principal investigator, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical CenterGershon Fink, M.D., Study director, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982384
- Sponsor's protocol ID
- SHEBA-09-7120-OK-CTIL
- Acronym
- COPD_CDM
- Status last verified
- May 2015
- First submitted
- 14 Sep 2009
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Disease Management Program in COPD Patients in the Community: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00982384
- Acronym / sponsor ID
- COPD_CDM / SHEBA-09-7120-OK-CTIL
- Keywords
- Chronic obstructive pulmonary disease, Disease management, Pulmonary rehabilitation, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,202 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Clalit Health Services
- Study start
- Oct 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Sep 2009 (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 comprehensive disease management program combined with best care recommended in clinical guidelines, is more effective than best care alone in patients with advanced chronic obstructive pulmonary disease (COPD).
Detailed description
The study objective is to evaluate the effectiveness of a comprehensive program among patients with advanced COPD, implemented by a multi-disciplinary team. The program consists of best care recommended in clinical guidelines, combined with disease management, compared to best care only.
The program will include designated COPD centers operated by multi-disciplinary teams (pulmonologists, nurse practitioners, physiotherapists, social workers and dietitians). Disease management will be provided in these centers by qualified designated nurses.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease management | Experimental | Other: Disease managementComprehensive disease management in addition to best care according to clinical guidelines for COPD patients |
| Best care | Active comparator | Other: Best careBest care according to clinical guidelines for COPD patients |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 40 years or older
- Advanced COPD
Key exclusion criteria (8 listed)
- Permanent tracheostomy
- Heart failure with significant left-ventricular dysfunction
- Severe other chronic disease
- Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate
- No telephone or permanent address
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 |
|---|---|---|
| Disease managementDisease management by COPD nurses, including active follow-up and coordination of care in addition to best care according to clinical guidelines for COPD patients | Other | Disease management |
| Best careComprehensive care for COPD patients recommended in clinical guidelines | Other | Best care |
Primary outcome
Hospital admission for acute exacerbation of COPD or all-cause mortality
Time frame: Within 2 to 5 years after randomization
6 secondary outcomes
Total days of hospitalization for acute exacerbations of COPD
Time frame: Within 2 to 5 years after randomization
Quality of life
Time frame: Within 2 to 5 years after randomization
Total number of acute exacerbations of COPD
Time frame: Within 2 to 5 years after randomization
Depression
Time frame: Within 2 to 5 years after randomization
Functional capacity
Time frame: Within 2 to 5 years after randomization
Spirometry parameters
Time frame: Within 2 to 5 years after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 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.
Ofra Kalter - Leibovici, M.D. principal investigator
Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center
Gershon Fink, M.D. study director
Clalit Health Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disease management and Best care in people with Chronic Obstructive Pulmonary Disease (COPD), 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 20 May 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hospital admission for acute exacerbation of COPD or all-cause mortality (time frame: Within 2 to 5 years after randomization). 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 20 May 2015.