Examine the Impact of Early Education on COPD Management
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02398643|
Recruitment Status : Recruiting
First Posted : March 25, 2015
Last Update Posted : September 6, 2017
|Condition or disease||Intervention/treatment|
|Chronic Obstructive Pulmonary Disease (COPD)||Other: Pulmonary Education (PE) Other: Usual Care|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Examine the Impact of Early Chronic Disease Management Education Following Hospital Discharge in Acute Exacerbation of COPD|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||September 2018|
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.
Other: Pulmonary Education (PE)
Patients enrolled in PE will undergo focused education sessions following discharge from hospital.
Patients randomized to usual care will receive general education sessions by a Certified Respiratory Educator within the month of being discharged.
Other: Usual Care
Patients enrolled in usual care will receive general education sessions following discharge from hospital.
- 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.
- 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
- Inflammatory markers (TNF-alpha) [ Time Frame: Change in baseline TNF-alpha post respiratory education and 6 months ]TNF-alpha
- Inflammatory markers (MMP-2) [ Time Frame: Change in baseline MMP-2 post respiratory education and 6 months ]MMP-2
- Inflammatory markers (CRP) [ Time Frame: Change in baseline CRP post respiratory education and 6 months ]CRP - -reactive protein is a non-specific serum marker of inflammation (range <8 is normal)
- Quality of Life (QoL) [ Time Frame: Change in baseline Quality of Life post respiratory education and 6 months ]COPD Assessment Tool (CAT) will be used to assess quality of life.
- Quality of Life (QoL) [ Time Frame: Change in baseline Quality of Life post respiratory education and 6 months ]St. George Respiratory Questionnaire (SGRQ) will be used to assess quality of life.
- Quality of Life (QoL) [ Time Frame: Change in baseline Quality of Life post respiratory education and 6 months ]COPD Self Efficacy Scale will be used to assess quality of life.
- Dyspnea [ Time Frame: Change in baseline dyspnea post respiratory education and 6 months ]Modified Medical Research Council Dyspnea Scale (MMRC) will be used to assess dyspnea (breathlessness)
- Physical Activity [ Time Frame: Change in baseline physical activity post respiratory education and 6 months ]Physical activity will be assessed by an accelerometer worn on the patients wrist or upper arm
- Hospital Re-admissions [ Time Frame: One year re-admission ]Re-admission rates for AECOPD will be documented
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398643
|Contact: Brandie Walker, MD, PhD, FRCPCfirstname.lastname@example.org|
|Contact: Lisette Machado, MScemail@example.com|
|University of Calgary||Recruiting|
|Calgary, Alberta, Canada, T2N4Z6|
|Contact: Brandie Walker, MD, PhD 403-220-4135 firstname.lastname@example.org|
|Contact: Lisette Machado, MD 403-210-7827 email@example.com|
|Principal Investigator: Michael Stickland, PhD|
|Sub-Investigator: Richard Leigh, MD,|
|Sub-Investigator: Brian H Rowe, MD, MSc|
|Sub-Investigator: Mohit Bhutani, MD, FRCPC|
|Sub-Investigator: Brandie Walker, MD, PhD, FRCPC|
|Principal Investigator:||Michael Stickland, PhD||University of Alberta|