Clinical trial NCT02343055: COPE With COPD Trial
Official title: Collaborative Self-Management Patient Education Will Improve Health Outcomes in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Pfizer
name: GlaxoSmithKline
First posted: 2015-01-21
Enrollment: 182
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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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Eligibility criteria: 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

Primary outcomes:
measure: COPD Assessment Test (CAT)
timeFrame: 1 Year
Secondary outcomes:
measure: Health Care Utilization for Emergency Department visits proportion and rate per year
timeFrame: 1 year
measure: Health Care Utilization for Hospital Admission proportion and rate per year
timeFrame: 1 year
measure: Severe Exacerbation proportion and rate per year
timeFrame: 1 year
Other outcomes:
measure: Quality of Life
timeFrame: 1 year
measure: Improvement in Knowledge of COPD and confidence in self-management
timeFrame: 1 year
measure: Process of Care
timeFrame: 1 year
measure: Dyspnea Improvement
timeFrame: 1 year
measure: Disease control
timeFrame: 1 year
measure: Symptom Profile
timeFrame: 1 year
measure: Forced Expiratory Volume at 1sec (FEV1) % predicted
timeFrame: 1 year
measure: Proportion of Patients on therapy appropriate to their stage of disease
timeFrame: 1 year
Locations:
city: Amherstburg
country: Canada
facility: Amherstburg FHT
state: Ontario
city: Chatham
country: Canada
facility: Chatham-Kent FHT
state: Ontario
city: Harrow
country: Canada
facility: Harrow FHT
state: Ontario
city: Leamington
country: Canada
facility: Leamington FHT
state: Ontario
Study officials:
affiliation: Lawson Health Research Institution
name: Christopher Licskai
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrone M, Masciantonio MG, Malus N, Stitt L, O'Callahan T, Roberts Z, Johnson L, Samson J, Durocher L, Ferrari M, Reilly M, Griffiths K, Licskai CJ; Primary Care Innovation Collaborative. The impact of integrated disease management in high-risk COPD patients in primary care. NPJ Prim Care Respir Med. 2019 Mar 28;29(1):8. doi: 10.1038/s41533-019-0119-9.