COPE With COPD Trial

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

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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Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Case Management and Self-Management Education

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Amherstburg, Ontario, Canada, N9V 0B4
      • Amherstburg FHT
    • Chatham, Ontario, Canada, N7L 5K5
      • Chatham-Kent FHT
    • Harrow, Ontario, Canada, NOR 1G0
      • Harrow FHT
    • Leamington, Ontario, Canada, N8H 1N8
      • Leamington FHT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: Usual Care; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Assessment Test (CAT)	COPD related quality of life measure in primary care.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Improvement of Quality of Life using the CAT score(COPD Assessment Test)	1 year
Improvement in Knowledge of COPD and confidence in self-management	Improvement in Bristol COPD Knowledge Questionnaire and patient self report	1 year
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
Dyspnea Improvement	Change in dyspnea using the modified MRC questionnaire - Medical Research Council (MRC).	1 year
Disease control	Disease control using the Clinical COPD questionnaire (CCQ)	1 year
Symptom Profile	Change in Symptom profile (cough, wheeze, sputum production)	1 year
Forced Expiratory Volume at 1sec (FEV1) % predicted	FEV1	1 year
Proportion of Patients on therapy appropriate to their stage of disease	Evaluate medication prescribed related to stage of disease	1 year

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: GlaxoSmithKline; Pfizer
• Investigators: Principal Investigator: Christopher Licskai, Lawson Health Research Institution

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: January 20, 2015
• First Posted (Estimate): January 21, 2015

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 00000941

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO