COPE With COPD Trial

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Case Management and Self-Management Education

• Registration Number: NCT02343055
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2014-10-22
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-21
• Status Verified: 2015-04
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case Management and Self-Management Education	Case Management and Self-Management Education	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.
Usual Care	Case Management and Self-Management Education	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.

Primary Outcome Measures

Name	Time	Method
COPD Assessment Test (CAT)	1 Year	COPD related quality of life measure in primary care.

Secondary Outcome Measures

Name	Time	Method
Health Care Utilization for Emergency Department visits proportion and rate per year	1 year	The proportion of subjects that utilized the Emergency for a COPD exacerbation
Health Care Utilization for Hospital Admission proportion and rate per year	1 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.
Severe Exacerbation proportion and rate per year	1 year	The proportion of subjects experiencing one or more exacerbations in the study interval. An exacerbation diary will be completed for each event.

Trial Locations

Locations (4)

Harrow FHT; 🇨🇦 Harrow, Ontario, Canada

Amherstburg FHT; 🇨🇦 Amherstburg, Ontario, Canada

Chatham-Kent FHT; 🇨🇦 Chatham, Ontario, Canada

Leamington FHT; 🇨🇦 Leamington, Ontario, Canada