COPE With COPD Trial

Study Overview
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Brief Summary
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The overall objective of this study is to evaluate a collaborative self-management intervention in patients with moderate to severe COPD in a primary care population. To achieve this objective the investigators developed a diagnostic and treatment pathway for the management of COPD in primary care that is based on national guidelines and focused on patient self-management. .

Official Title
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Collaborative Self-Management Patient Education Will Improve Health Outcomes in COPD

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Case Management and Self-Management Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current or Ex-smokers 40 years of age or over Minimum 10 pack year smoking history Post-bronchodilator FEV1 of 70% or less (4 puffs of Salbutamol) and Forced Expiratory Volume at 1sec to Forced Vital Capacity (FEV1/FVC) ratio 70% or less A history of two exacerbations (involving treatment and/or visit to a health care practitioner) in the past 3 years OR 1 exacerbation in the past year Provides informed consent Exclusion Criteria: COPD exacerbation in the past 4 weeks Diagnosis of asthma prior to the age of 40 years Co-existing illness that could interfere with study results (ie. Congestive Heart Failure with exacerbation of symptoms) Scheduled for COPD rehabilitation A terminal illness

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case Management and Self-Management Education<br>A Certified Respiratory Educator (CRE) will obtain a detailed COPD history, provide general and self-management education, and confirm a management plan with the primary care physician. Specific elements of evidence-based management are targetted for intervention. Subjects will return for a follow-up visit in-person with the interdisciplinary care team including a CRE to review their health status including COPD symptoms, exacerbation diary, symptoms, MRC scale, etc as a minimum at 3 and 12 months. Telephone follow up will occur at a minimum at 6 and 9 months. | Other: Case Management and Self-Management Education<br>* A Certified Respiratory Educator (CRE) will obtain a detailed COPD history, provide general and self-management education, and confirm a management plan with the primary care physician. Specific elements of evidence-based management are targetted for intervention. Subjects will return for a follow-up visit in-person with the interdisciplinary care team including a CRE to review their health status including COPD symptoms, exacerbation diary, symptoms, MRC scale, etc as a minimum at 3 and 12 months. Telephone follow up will occur at a minimum at 6 and 9 months.<br>|
| Placebo Comparator: Usual Care<br>A Certified Respiratory Educator (CRE) will meet with subjects to obtain a detailed COPD history and do a breathing test. Subjects will receive COPD care as usually provided by their physician. | Other: Case Management and Self-Management Education<br>* A Certified Respiratory Educator (CRE) will obtain a detailed COPD history, provide general and self-management education, and confirm a management plan with the primary care physician. Specific elements of evidence-based management are targetted for intervention. Subjects will return for a follow-up visit in-person with the interdisciplinary care team including a CRE to review their health status including COPD symptoms, exacerbation diary, symptoms, MRC scale, etc as a minimum at 3 and 12 months. Telephone follow up will occur at a minimum at 6 and 9 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD Assessment Test (CAT) | COPD related quality of life measure in primary care. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Care Utilization for Emergency Department visits proportion and rate per year | The proportion of subjects that utilized the Emergency for a COPD exacerbation | 1 year | 
| Health Care Utilization for Hospital Admission proportion and rate per year | The proportion of subjects that were admitted to hospital for a COPD exacerbation An exacerbation is defined as an increase in or the onset of more than one respiratory symptom (cough, sputum, sputum purulence, wheezing, or dyspnea) lasting 3 days or more and requiring treatment with an antibiotic or a systemic corticosteroid. Respiratory status had to return to baseline for at least 72 hours before another exacerbation would be counted. | 1 year | 
| Severe Exacerbation proportion and rate per year | The proportion of subjects experiencing one or more exacerbations in the study interval. An exacerbation diary will be completed for each event. | 1 year |