Chronic Obstructive Pulmonary DiseasePhase 3NCT01045213
Integrated Care Program for Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Integrated Care in people with Chronic Obstructive Pulmonary Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Integrated eHealth is an innovative, proactive approach to the management of patients with chronic cardiopulmonary disease. Our overall goal is to improve the health of patients by integrating guideline-based education, remote disease monitoring, coordinator-based disease management and healthcare provider-initiated… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Integrated Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2009
- Phase
- Phase 3
- 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
- COPD Diagnosis by Gold Guidelines
- Airflow obstruction on spirometry defined by an FEV1/FVC less than or equal to 70% and an FEV1 less than 50% predicted, or and FEV1 greater than or equal to 50% predicted with a history of a COPD exacerbation within one year, or an FEV1 greater than or equal to 50% predicted and on long-term oxygen therapy.
- Standard land-line telephone
- Legal US residency status residing in Adams, Alamosa, Bent, Crowley, Dolores, El Paso, Fremont, Kiowa, Logan, Morgan, Montezuma, Otero, Prowers, Rio Blanco, or Washington counties in Colorado
Who cannot join
- Asthma
- Co-existing conditions that are likely to cause death within two years. Patients with CXR evidence of interstitial lung disease, or other pulmonary diagnoses at the time of enrollment, aside from COPD-related bronchiectasis. Patients with end-stage liver, renal or muscle disease, HIV, or a diagnosis of dementia.
- Participation in another treatment study
- Inability or unwillingness to cooperate with self-monitoring and reporting components
- Prisoners, pregnant women, institutionalized patients
- Current alcohol or drug abuse
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- Non-English speakers
- Inability to complete a consent
- Illegal alien, non-Colorado resident, or non-resident of targeted counties
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Phase 3 Study of the Efficacy of Proactive Integrated Care in Advanced COPD Patients Located in Areas With High COPD-related Mortality
Integrated eHealth is an innovative, proactive approach to the management of patients with chronic cardiopulmonary disease. Our overall goal is to improve the health of patients by integrating guideline-based education, remote disease monitoring, coordinator-based disease management and healthcare provider-initiated therapy. Patients enrolled in the program receive a set of equipment, including a Health Buddy® telemonitor that connects to a normal telephone, as well as instruments to measure oxygen levels (pulse oximeter), lung function (spirometer) and activity (pedometer). Through the Health Buddy® patients receive guideline-based disease education in their own homes. The Health Buddy® also allows patients to transmit daily information about their symptoms, oxygen levels, lung function and ability to walk to program coordinators located at the University of Colorado Hospital. Our program coordinators are highly experienced nurses or respiratory therapists with expertise in the management of chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Through this remote disease education/monitoring program, patients learn to take a more active role in the management of their own disease. However, once the coordinators identify early warning signs of a potential problem, patients are contacted and connected to their primary healthcare provider for early intervention. By this integrated approach to care, patients learn self-management techniques, physician communication is enhanced, and early interventions for problems are possible. We propose to target the Integrated eHealth Program to areas of Colorado that are highly impacted by COPD.
Key Objectives: The key objectives are to improve COPD care in the 16 Colorado counties with high COPD mortality rates.
Read more
Target Population: We will target patients with severe or very severe COPD.
Expected Outcomes: We expect that this study will increase the use of evidence-based guidelines in the screening, diagnosis and treatment of COPD, resulting in improved quality-of-life and a reduction in healthcare utilization.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Integrated Care
- Keywords
- Chronic obstructive pulmonary disease, COPD
- 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.
Integrated CareOther
Study looking at the efficacy of a combination of Guideline-based COPD education, self-management training, remote telemonitoring and enhanced communication with a coordinator.
| Study group | Role | What they receive |
|---|---|---|
| Proactive Integrated Care | Experimental | COPD education, self-management education, remote monitoring (Health Buddy, pulse oximeter, pedometer, spirometer) and enhance communication with cell phone contact with a coordinator. Receives: Other: Integrated Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life measured by the St. Georges Respiratory Questionnaire
Measured: 3 months
Secondary outcomes (7)
Guideline-based medical care
Measured: 3 months
Oxygen utilization and pre/post exercise oxygen saturations
Measured: 3 months
Smoking status
Measured: 3 months
Exercise status measured by the 6 minute walk test
Measured: 3 months
Symptoms including cough, sputum production and dyspnea (measured by the modified Medical Research Council (MMRC) dyspnea scale)
Measured: 3 months
Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) Index
Measured: 3 months
Healthcare utilization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Vandivier, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045213
- Sponsor's protocol ID
- 08-0588
- Other IDs
- 09 FLA 000317
- Status last verified
- Oct 2012
- First submitted
- 6 Jan 2010
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of the Efficacy of Proactive Integrated Care in Advanced COPD Patients Located in Areas With High COPD-related Mortality
- ClinicalTrials.gov ID
- NCT01045213
- Acronym / sponsor ID
- 08-0588
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Jan 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.
Integrated eHealth is an innovative, proactive approach to the management of patients with chronic cardiopulmonary disease. Our overall goal is to improve the health of patients by integrating guideline-based education, remote disease monitoring, coordinator-based disease management and healthcare provider-initiated therapy. Patients enrolled in the program receive a set of equipment, including a Health Buddy® telemonitor that connects to a normal telephone, as well as instruments to measure oxygen levels (pulse oximeter), lung function (spirometer) and activity (pedometer). Through the Health Buddy® patients receive guideline-based disease education in their own homes. The Health Buddy® also allows patients to transmit daily information about their symptoms, oxygen levels, lung function and ability to walk to program coordinators located at the University of Colorado Hospital. Our program coordinators are highly experienced nurses or respiratory therapists with expertise in the management of chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Through this remote disease education/monitoring program, patients learn to take a more active role in the management of their own disease. However, once the coordinators identify early warning signs of a potential problem, patients are contacted and connected to their primary healthcare provider for early intervention. By this integrated approach to care, patients learn self-management techniques, physician communication is enhanced, and early interventions for problems are possible. We propose to target the Integrated eHealth Program to areas of Colorado that are highly impacted by COPD.
Key Objectives: The key objectives are to improve COPD care in the 16 Colorado counties with high COPD mortality rates.
Target Population: We will target patients with severe or very severe COPD.
Expected Outcomes: We expect that this study will increase the use of evidence-based guidelines in the screening, diagnosis and treatment of COPD, resulting in improved quality-of-life and a reduction in healthcare utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proactive Integrated Care | Experimental | Other: Integrated CareCOPD education, self-management education, remote monitoring (Health Buddy, pulse oximeter, pedometer, spirometer) and enhance communication with cell phone contact with a coordinator. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD Diagnosis by Gold Guidelines
- Airflow obstruction on spirometry defined by an FEV1/FVC less than or equal to 70% and an FEV1 less than 50% predicted, or and FEV1 greater than or equal to 50% predicted with a history of a COPD exacerbation within one year, or an FEV1 greater than or equal to 50% predicted and on long-term oxygen therapy.
- Standard land-line telephone
- Legal US residency status residing in Adams, Alamosa, Bent, Crowley, Dolores, El Paso, Fremont, Kiowa, Logan, Morgan, Montezuma, Otero, Prowers, Rio Blanco, or Washington counties in Colorado
Key exclusion criteria (9 listed)
- Asthma
- Co-existing conditions that are likely to cause death within two years. Patients with CXR evidence of interstitial lung disease, or other pulmonary diagnoses at the time of enrollment, aside from COPD-related bronchiectasis. Patients with end-stage liver, renal or muscle disease, HIV, or a diagnosis of dementia.
- Participation in another treatment study
- Inability or unwillingness to cooperate with self-monitoring and reporting components
- Prisoners, pregnant women, institutionalized patients
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 |
|---|---|---|
| Integrated CareStudy looking at the efficacy of a combination of Guideline-based COPD education, self-management training, remote telemonitoring and enhanced communication with a coordinator. | Other | Proactive Integrated Care |
Primary outcome
Quality of Life measured by the St. Georges Respiratory Questionnaire
Time frame: 3 months
7 secondary outcomes
Guideline-based medical care
Time frame: 3 months
Oxygen utilization and pre/post exercise oxygen saturations
Time frame: 3 months
Smoking status
Time frame: 3 months
Exercise status measured by the 6 minute walk test
Time frame: 3 months
Symptoms including cough, sputum production and dyspnea (measured by the modified Medical Research Council (MMRC) dyspnea scale)
Time frame: 3 months
Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) Index
Time frame: 3 months
Healthcare utilization
Time frame: 3 months
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 5 Oct 2012.
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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.
William Vandivier, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Integrated Care in people with Chronic Obstructive Pulmonary Disease, run by University of Colorado, Denver at 1 site in United States.
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 4 inclusion and 9 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 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of Life measured by the St. Georges Respiratory Questionnaire (time frame: 3 months). 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 5 Oct 2012.