COPE With COPD Trial

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's182 enrolled

Overview

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. .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

182

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Case Management and Self-Management EducationOTHER

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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (4)

Amherstburg FHT

Amherstburg, Ontario, Canada

Chatham-Kent FHT

Chatham, Ontario, Canada

Harrow FHT

Harrow, Ontario, Canada

Leamington FHT

Leamington, Ontario, Canada

Outcomes

Primary Outcomes

COPD Assessment Test (CAT)

COPD related quality of life measure in primary care.

Time frame: 1 Year

Secondary Outcomes

Health Care Utilization for Emergency Department visits proportion and rate per year

The proportion of subjects that utilized the Emergency for a COPD exacerbation

Time frame: 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.

Time frame: 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.

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.