COPE With COPD Trial

Lawson Health Research Institute

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Case Management and Self-Management Education

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02343055

00000941

Details and patient eligibility

About

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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Enrollment: 182 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups, including a placebo group

Case Management and Self-Management Education

Experimental group

Description:

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.

Treatment:

Other: Case Management and Self-Management Education

Usual Care

Placebo Comparator group

Description:

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.

Treatment:

Other: Case Management and Self-Management Education