- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02398643
Examine the Impact of Early Education on COPD Management
Examine the Impact of Early Chronic Disease Management Education Following Hospital Discharge in Acute Exacerbation of COPD
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N4Z6
- University of Calgary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients admitted to the pulmonary ward for an AECOPD will be offered participation into this arm of the study.
Exclusion Criteria:
- Patients found to have an acute cardiac injury during admission, mobility issues or residence outside the greater Calgary area will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Early Pulmonary Education (EPE)
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.
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Patients enrolled in PE will undergo focused education sessions following discharge from hospital.
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Other: Usual Care
Patients randomized to usual care will receive general education sessions by a Certified Respiratory Educator within the month of being discharged.
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Patients enrolled in usual care will receive general education sessions following discharge from hospital.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascular Function
Time Frame: Change in baseline vascular function post respiratory education and 6 months
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Peripheral arterial tone (PAT) and arterial stiffness will be used to assess vascular function.
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Change in baseline vascular function post respiratory education and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory markers (IL-6)
Time Frame: Change in baseline IL-6 post respiratory education and 6 months
|
IL-6: is an interleukin that acts as both a pro-inflammatory and anti-inflammatory cytokine
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Change in baseline IL-6 post respiratory education and 6 months
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Inflammatory markers (TNF-alpha)
Time Frame: Change in baseline TNF-alpha post respiratory education and 6 months
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TNF-alpha
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Change in baseline TNF-alpha post respiratory education and 6 months
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Inflammatory markers (MMP-2)
Time Frame: Change in baseline MMP-2 post respiratory education and 6 months
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MMP-2
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Change in baseline MMP-2 post respiratory education and 6 months
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Inflammatory markers (CRP)
Time Frame: Change in baseline CRP post respiratory education and 6 months
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CRP - -reactive protein is a non-specific serum marker of inflammation (range <8 is normal)
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Change in baseline CRP post respiratory education and 6 months
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Quality of Life (QoL)
Time Frame: Change in baseline Quality of Life post respiratory education and 6 months
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COPD Assessment Tool (CAT) will be used to assess quality of life.
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Change in baseline Quality of Life post respiratory education and 6 months
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Quality of Life (QoL)
Time Frame: Change in baseline Quality of Life post respiratory education and 6 months
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St. George Respiratory Questionnaire (SGRQ) will be used to assess quality of life.
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Change in baseline Quality of Life post respiratory education and 6 months
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Quality of Life (QoL)
Time Frame: Change in baseline Quality of Life post respiratory education and 6 months
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COPD Self Efficacy Scale will be used to assess quality of life.
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Change in baseline Quality of Life post respiratory education and 6 months
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Dyspnea
Time Frame: Change in baseline dyspnea post respiratory education and 6 months
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Modified Medical Research Council Dyspnea Scale (MMRC) will be used to assess dyspnea (breathlessness)
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Change in baseline dyspnea post respiratory education and 6 months
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Physical Activity
Time Frame: Change in baseline physical activity post respiratory education and 6 months
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Physical activity will be assessed by an accelerometer worn on the patients wrist or upper arm
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Change in baseline physical activity post respiratory education and 6 months
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Hospital Re-admissions
Time Frame: One year re-admission
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Re-admission rates for AECOPD will be documented
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One year re-admission
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB14-0504
- AIHS-CRIO Project Grant (Other Identifier: Alberta Innovated Health Solutions (AIHS))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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