Chronic Obstructive Pulmonary Disease (COPD)NCT02398643
Examine the Impact of Early Education on COPD Management
A study testing Pulmonary Education (PE) in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Alberta at 1 site in Canada.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations result in frequent, prolonged hospitalizations. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Pulmonary Education (PE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Dec 2020
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to the pulmonary ward for an AECOPD will be offered participation into this arm of the study.
Who cannot join
- Patients found to have an acute cardiac injury during admission, mobility issues or residence outside the greater Calgary area will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examine the Impact of Early Chronic Disease Management Education Following Hospital Discharge in Acute Exacerbation of COPD
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations result in frequent, prolonged hospitalizations. While originally considered a disease specific to the lung, data has shown that COPD is associated with substantial cardiovascular (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown; however, it may be due to chronic inflammation which is exacerbated with a flare-up of the disease, and/or chronic inactivity which is similarly worsened with bed-rest during a hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk. Disease management programs, such as pulmonary rehabilitation and patient self-management education, are part of guideline therapy for COPD; however, these are not regularly implemented following a hospitalization, and how these interventions affect patient outcomes, behavior, physical activity, inflammation and CV risk have not been well studied. The proposed long-term project will examine how early referral to chronic disease management programs after hospital discharge, affect patient outcomes. This study will provide invaluable information about outpatient management for a disease which has a tremendous impact on healthcare.
Read the detailed description
Purpose: To examine the impact of early pulmonary education (PE) following hospital discharge on QoL, pulmonary/CV outcomes and AECOPD hospitalizations.
Rationale: Studies have shown that education improves self-efficacy and QoL in COPD. Whether these improvements translate to increased exercise tolerance, physical activity, reduced CV risk and hospitalizations in patients recently discharged from hospital requires examination.
Hypothesis: Patients who receive early education will have improved QoL, pulmonary/CV outcomes, and less COPD hospitalizations in the 6 months following hospital discharge. Education will improve self efficacy, physical activity and QoL while reducing CV risk as compared to usual care.
Study Design \& Subject Recruitment: In Calgary, patients discharged following an AECOPD hospitalization are referred to the Calgary COPD and Asthma Program (CCAP) where they are seen by a Certified Respiratory Educator 1-2 times within the month following discharge. For this study, patients will be recruited from the CCAP program and randomized into receiving usual care; general education sessions over the month following discharge, or the experimental arm; focused education following discharge from hospital. Patients found to have an acute cardiac injury, mobility issues or residence outside the greater Calgary area will be excluded. All education visits will be 1hr in length, and occur at a local outpatient clinic. The education will focus on patient self-management and will use Living Well with COPD supporting literature (www.livingwellwithcopd.com) designed to improve patient self-management and physical activity. All patients will be followed up 6 months after discharge and will be interviewed to assess disease status, management review and if there has been a history of recurrence or relapse of the AECOPD. Hospital admissions and length of stay will be obtained through electronic medical records as described above. Patient assessments will include: quality of life, 6min walk, dyspnea, self-efficacy, physical activity, pulse wave velocity (PWV), vascular function and systemic inflammation (TNF, MMP-2, IL-6 and CRP). All data will be collected before, immediately and 6 months after education. The control group will have the same data collected at the same scheduled time. See above for descriptions of methods.
Data Handling: Data will be entered onto a secure anonymized database.
Data Analysis: The influence of education on QoL, 6min walk, dyspnea, self-efficacy, physical activity, pulse wave velocity, vascular function and systemic inflammation will be evaluated using a multivariate mixed-model multivariate analysis of variance (MANOVA) with treatment (education vs. usual care) being a fixed between-group variable and time (pre, immediate post, 6months post) as a repeated variable.
Sample size: Based on previous work, a total sample size of 140 (70 in each group) will be sufficient to detect a clinically significant difference in QoL and a significant difference in hospital readmission rates. Based on outhe investigators r recent work, this sample could detect a 10% difference in PWV and physical activity.
- Being tested
- Pulmonary Education (PE), Usual Care
- Keywords
- Acute Exacerbation of COPD, COPD, Emphysema, Chronic Bronchitis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Education (PE)Other
Patients enrolled in PE will undergo focused education sessions following discharge from hospital.
Usual CareOther
Patients enrolled in usual care will receive general education sessions following discharge from hospital.
| Study group | Role | What they receive |
|---|---|---|
| Early Pulmonary Education (EPE) | Other | Patients randomized to EPE will receive focused education sessions by a Certified Respiratory Educator. Education sessions will start within two weeks of discharge from hospital. Receives: Other: Pulmonary Education (PE) |
| Usual Care | Other | Patients randomized to usual care will receive general education sessions by a Certified Respiratory Educator within the month of being discharged. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Function
Peripheral arterial tone (PAT) and arterial stiffness will be used to assess vascular function.
Measured: Change in baseline vascular function post respiratory education and 6 months
Secondary outcomes (10)
Inflammatory markers (IL-6)
IL-6: is an interleukin that acts as both a pro-inflammatory and anti-inflammatory cytokine
Measured: Change in baseline IL-6 post respiratory education and 6 months
Inflammatory markers (TNF-alpha)
TNF-alpha
Measured: Change in baseline TNF-alpha post respiratory education and 6 months
Inflammatory markers (MMP-2)
MMP-2
Measured: Change in baseline MMP-2 post respiratory education and 6 months
Inflammatory markers (CRP)
CRP - -reactive protein is a non-specific serum marker of inflammation (range <8 is normal)
Measured: Change in baseline CRP post respiratory education and 6 months
Quality of Life (QoL)
COPD Assessment Tool (CAT) will be used to assess quality of life.
Measured: Change in baseline Quality of Life post respiratory education and 6 months
Quality of Life (QoL)
St. George Respiratory Questionnaire (SGRQ) will be used to assess quality of life.
Measured: Change in baseline Quality of Life post respiratory education and 6 months
Quality of Life (QoL)
COPD Self Efficacy Scale will be used to assess quality of life.
Measured: Change in baseline Quality of Life post respiratory education and 6 months
Dyspnea
Modified Medical Research Council Dyspnea Scale (MMRC) will be used to assess dyspnea (breathlessness)
Measured: Change in baseline dyspnea post respiratory education and 6 months
Physical Activity
Physical activity will be assessed by an accelerometer worn on the patients wrist or upper arm
Measured: Change in baseline physical activity post respiratory education and 6 months
Hospital Re-admissions
Re-admission rates for AECOPD will be documented
Measured: One year re-admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2019
- Study completionDec 2020
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 University of AlbertaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
- Investigators
- Michael Stickland, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398643
- Sponsor's protocol ID
- REB14-0504
- Other IDs
- AIHS-CRIO Project Grant
- Status last verified
- Jul 2021
- First submitted
- 20 Mar 2015
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examine the Impact of Early Chronic Disease Management Education Following Hospital Discharge in Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT02398643
- Acronym / sponsor ID
- REB14-0504
- Keywords
- Acute Exacerbation of COPD, COPD, Emphysema, Chronic Bronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 25 Mar 2015 (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.
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations result in frequent, prolonged hospitalizations. While originally considered a disease specific to the lung, data has shown that COPD is associated with substantial cardiovascular (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown; however, it may be due to chronic inflammation which is exacerbated with a flare-up of the disease, and/or chronic inactivity which is similarly worsened with bed-rest during a hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk. Disease management programs, such as pulmonary rehabilitation and patient self-management education, are part of guideline therapy for COPD; however, these are not regularly implemented following a hospitalization, and how these interventions affect patient outcomes, behavior, physical activity, inflammation and CV risk have not been well studied. The proposed long-term project will examine how early referral to chronic disease management programs after hospital discharge, affect patient outcomes. This study will provide invaluable information about outpatient management for a disease which has a tremendous impact on healthcare.
Detailed description
Purpose: To examine the impact of early pulmonary education (PE) following hospital discharge on QoL, pulmonary/CV outcomes and AECOPD hospitalizations.
Rationale: Studies have shown that education improves self-efficacy and QoL in COPD. Whether these improvements translate to increased exercise tolerance, physical activity, reduced CV risk and hospitalizations in patients recently discharged from hospital requires examination.
Hypothesis: Patients who receive early education will have improved QoL, pulmonary/CV outcomes, and less COPD hospitalizations in the 6 months following hospital discharge. Education will improve self efficacy, physical activity and QoL while reducing CV risk as compared to usual care.
Study Design \& Subject Recruitment: In Calgary, patients discharged following an AECOPD hospitalization are referred to the Calgary COPD and Asthma Program (CCAP) where they are seen by a Certified Respiratory Educator 1-2 times within the month following discharge. For this study, patients will be recruited from the CCAP program and randomized into receiving usual care; general education sessions over the month following discharge, or the experimental arm; focused education following discharge from hospital. Patients found to have an acute cardiac injury, mobility issues or residence outside the greater Calgary area will be excluded. All education visits will be 1hr in length, and occur at a local outpatient clinic. The education will focus on patient self-management and will use Living Well with COPD supporting literature (www.livingwellwithcopd.com) designed to improve patient self-management and physical activity. All patients will be followed up 6 months after discharge and will be interviewed to assess disease status, management review and if there has been a history of recurrence or relapse of the AECOPD. Hospital admissions and length of stay will be obtained through electronic medical records as described above. Patient assessments will include: quality of life, 6min walk, dyspnea, self-efficacy, physical activity, pulse wave velocity (PWV), vascular function and systemic inflammation (TNF, MMP-2, IL-6 and CRP). All data will be collected before, immediately and 6 months after education. The control group will have the same data collected at the same scheduled time. See above for descriptions of methods.
Data Handling: Data will be entered onto a secure anonymized database.
Data Analysis: The influence of education on QoL, 6min walk, dyspnea, self-efficacy, physical activity, pulse wave velocity, vascular function and systemic inflammation will be evaluated using a multivariate mixed-model multivariate analysis of variance (MANOVA) with treatment (education vs. usual care) being a fixed between-group variable and time (pre, immediate post, 6months post) as a repeated variable.
Sample size: Based on previous work, a total sample size of 140 (70 in each group) will be sufficient to detect a clinically significant difference in QoL and a significant difference in hospital readmission rates. Based on outhe investigators r recent work, this sample could detect a 10% difference in PWV and physical activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Pulmonary Education (EPE) | Other | Other: Pulmonary Education (PE)Patients randomized to EPE will receive focused education sessions by a Certified Respiratory Educator. Education sessions will start within two weeks of discharge from hospital. |
| Usual Care | Other | Other: Usual CarePatients randomized to usual care will receive general education sessions by a Certified Respiratory Educator within the month of being discharged. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the pulmonary ward for an AECOPD will be offered participation into this arm of the study.
Key exclusion criteria (1 listed)
- Patients found to have an acute cardiac injury during admission, mobility issues or residence outside the greater Calgary area will be excluded.
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 Education (PE)Patients enrolled in PE will undergo focused education sessions following discharge from hospital. | Other | Early Pulmonary Education (EPE) |
| Usual CarePatients enrolled in usual care will receive general education sessions following discharge from hospital. | Other | Usual Care |
Primary outcome
Vascular Function
Time frame: Change in baseline vascular function post respiratory education and 6 months
Peripheral arterial tone (PAT) and arterial stiffness will be used to assess vascular function.
10 secondary outcomes
Inflammatory markers (IL-6)
Time frame: Change in baseline IL-6 post respiratory education and 6 months
Inflammatory markers (TNF-alpha)
Time frame: Change in baseline TNF-alpha post respiratory education and 6 months
Inflammatory markers (MMP-2)
Time frame: Change in baseline MMP-2 post respiratory education and 6 months
Inflammatory markers (CRP)
Time frame: Change in baseline CRP post respiratory education and 6 months
Quality of Life (QoL)
Time frame: Change in baseline Quality of Life post respiratory education and 6 months
Quality of Life (QoL)
Time frame: Change in baseline Quality of Life post respiratory education and 6 months
Quality of Life (QoL)
Time frame: Change in baseline Quality of Life post respiratory education and 6 months
Dyspnea
Time frame: Change in baseline dyspnea post respiratory education and 6 months
Physical Activity
Time frame: Change in baseline physical activity post respiratory education and 6 months
Hospital Re-admissions
Time frame: One year re-admission
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 27 Jul 2021.
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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.
Michael Stickland, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Education (PE) in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Alberta at 1 site in Canada.
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 1 inclusion and 1 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 27 Jul 2021. 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 Canada. 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?
Vascular Function (time frame: Change in baseline vascular function post respiratory education and 6 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 27 Jul 2021.