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Examine the Impact of Early Education on COPD Management

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pulmonary Education (PE)
Usual Care
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Acute Exacerbation of COPD, COPD, Emphysema, Chronic Bronchitis

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Early Pulmonary Education (EPE)

Usual Care

Arm Description

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.

Patients randomized to usual care will receive general education sessions by a Certified Respiratory Educator within the month of being discharged.

Outcomes

Primary Outcome Measures

Vascular Function
Peripheral arterial tone (PAT) and arterial stiffness will be used to assess vascular function.

Secondary Outcome Measures

Inflammatory markers (IL-6)
IL-6: is an interleukin that acts as both a pro-inflammatory and anti-inflammatory cytokine
Inflammatory markers (TNF-alpha)
TNF-alpha
Inflammatory markers (MMP-2)
MMP-2
Inflammatory markers (CRP)
CRP - -reactive protein is a non-specific serum marker of inflammation (range <8 is normal)
Quality of Life (QoL)
COPD Assessment Tool (CAT) will be used to assess quality of life.
Quality of Life (QoL)
St. George Respiratory Questionnaire (SGRQ) will be used to assess quality of life.
Quality of Life (QoL)
COPD Self Efficacy Scale will be used to assess quality of life.
Dyspnea
Modified Medical Research Council Dyspnea Scale (MMRC) will be used to assess dyspnea (breathlessness)
Physical Activity
Physical activity will be assessed by an accelerometer worn on the patients wrist or upper arm
Hospital Re-admissions
Re-admission rates for AECOPD will be documented

Full Information

First Posted
March 20, 2015
Last Updated
July 23, 2021
Sponsor
University of Alberta
Collaborators
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT02398643
Brief Title
Examine the Impact of Early Education on COPD Management
Official Title
Examine the Impact of Early Chronic Disease Management Education Following Hospital Discharge in Acute Exacerbation of COPD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Acute Exacerbation of COPD, COPD, Emphysema, Chronic Bronchitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Pulmonary Education (EPE)
Arm Type
Other
Arm Description
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.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Patients randomized to usual care will receive general education sessions by a Certified Respiratory Educator within the month of being discharged.
Intervention Type
Other
Intervention Name(s)
Pulmonary Education (PE)
Intervention Description
Patients enrolled in PE will undergo focused education sessions following discharge from hospital.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patients enrolled in usual care will receive general education sessions following discharge from hospital.
Primary Outcome Measure Information:
Title
Vascular Function
Description
Peripheral arterial tone (PAT) and arterial stiffness will be used to assess vascular function.
Time Frame
Change in baseline vascular function post respiratory education and 6 months
Secondary Outcome Measure Information:
Title
Inflammatory markers (IL-6)
Description
IL-6: is an interleukin that acts as both a pro-inflammatory and anti-inflammatory cytokine
Time Frame
Change in baseline IL-6 post respiratory education and 6 months
Title
Inflammatory markers (TNF-alpha)
Description
TNF-alpha
Time Frame
Change in baseline TNF-alpha post respiratory education and 6 months
Title
Inflammatory markers (MMP-2)
Description
MMP-2
Time Frame
Change in baseline MMP-2 post respiratory education and 6 months
Title
Inflammatory markers (CRP)
Description
CRP - -reactive protein is a non-specific serum marker of inflammation (range <8 is normal)
Time Frame
Change in baseline CRP post respiratory education and 6 months
Title
Quality of Life (QoL)
Description
COPD Assessment Tool (CAT) will be used to assess quality of life.
Time Frame
Change in baseline Quality of Life post respiratory education and 6 months
Title
Quality of Life (QoL)
Description
St. George Respiratory Questionnaire (SGRQ) will be used to assess quality of life.
Time Frame
Change in baseline Quality of Life post respiratory education and 6 months
Title
Quality of Life (QoL)
Description
COPD Self Efficacy Scale will be used to assess quality of life.
Time Frame
Change in baseline Quality of Life post respiratory education and 6 months
Title
Dyspnea
Description
Modified Medical Research Council Dyspnea Scale (MMRC) will be used to assess dyspnea (breathlessness)
Time Frame
Change in baseline dyspnea post respiratory education and 6 months
Title
Physical Activity
Description
Physical activity will be assessed by an accelerometer worn on the patients wrist or upper arm
Time Frame
Change in baseline physical activity post respiratory education and 6 months
Title
Hospital Re-admissions
Description
Re-admission rates for AECOPD will be documented
Time Frame
One year re-admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stickland, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4Z6
Country
Canada

12. IPD Sharing Statement

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Examine the Impact of Early Education on COPD Management

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