COPE With COPD Trial

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343055
• Other study ID #: 00000941
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Amherstburg FHT	Amherstburg	Ontario
Canada	Chatham-Kent FHT	Chatham	Ontario
Canada	Harrow FHT	Harrow	Ontario
Canada	Leamington FHT	Leamington	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	GlaxoSmithKline, Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life	Improvement of Quality of Life using the CAT score(COPD Assessment Test)	1 year
Other	Improvement in Knowledge of COPD and confidence in self-management	Improvement in Bristol COPD Knowledge Questionnaire and patient self report	1 year
Other	Process of Care	Process of care: have written action plan, used action plan, advised to quit smoking, offered pharmacologic help with quitting, quit smoking, current packs/day, diagnosis confirmed by spirometry, vaccination rates, instructed on inhaler technique, vaccination rates	1 year
Other	Dyspnea Improvement	Change in dyspnea using the modified MRC questionnaire - Medical Research Council (MRC).	1 year
Other	Disease control	Disease control using the Clinical COPD questionnaire (CCQ)	1 year
Other	Symptom Profile	Change in Symptom profile (cough, wheeze, sputum production)	1 year
Other	Forced Expiratory Volume at 1sec (FEV1) % predicted	FEV1	1 year
Other	Proportion of Patients on therapy appropriate to their stage of disease	Evaluate medication prescribed related to stage of disease	1 year
Primary	COPD Assessment Test (CAT)	COPD related quality of life measure in primary care.	1 Year
Secondary	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
Secondary	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
Secondary	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