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Examine the Impact of Early Education on COPD Management

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by University of Alberta
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT02398643
First received: March 20, 2015
Last updated: March 5, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Other: Pulmonary Education (PE)
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Supportive Care
Official Title: Examine the Impact of Early Chronic Disease Management Education Following Hospital Discharge in Acute Exacerbation of COPD

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: March 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Usual Care
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02398643

Contacts
Contact: Brandie Walker, MD, PhD, FRCPC 403-220-4135 blthorla@ucalgary.ca
Contact: Lisette Machado, MSc 403-210-7827 lmachado@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N4Z6
Contact: Brandie Walker, MD, PhD    403-220-4135    blthorla@ucalgary.ca   
Contact: Lisette Machado, MD    403-210-7827    lmachado@ucalgary.ca   
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         
Sponsors and Collaborators
University of Alberta
University of Calgary
Investigators
Principal Investigator: Michael Stickland, PhD University of Alberta
  More Information

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02398643     History of Changes
Other Study ID Numbers: REB14-0504
AIHS-CRIO Project Grant ( Other Identifier: Alberta Innovated Health Solutions (AIHS) )
Study First Received: March 20, 2015
Last Updated: March 5, 2017

Keywords provided by University of Alberta:
Acute Exacerbation of COPD
COPD
Emphysema
Chronic Bronchitis

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 25, 2017