Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02398643 |
| Other study ID # |
REB14-0504 |
| Secondary ID |
AIHS-CRIO Projec |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2015 |
| Est. completion date |
December 2020 |
Study information
| Verified date |
July 2021 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
