Back to resultsCOPE With COPD Trial
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Case Management and Self-Management Education
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
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
Sites / Locations
- Amherstburg FHT
- Chatham-Kent FHT
- Harrow FHT
- Leamington FHT
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Case Management and Self-Management Education
Usual Care
Arm 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.
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.
Outcomes
Primary Outcome Measures
COPD Assessment Test (CAT)
COPD related quality of life measure in primary care.
Secondary Outcome Measures
Health Care Utilization for Emergency Department visits proportion and rate per year
The proportion of subjects that utilized the Emergency for a COPD exacerbation
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.
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.
Full Information
NCT ID
NCT02343055
First Posted
October 22, 2014
Last Updated
July 26, 2018
Sponsor
Lawson Health Research Institute
Collaborators
Pfizer, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT02343055
Brief Title
COPE With COPD Trial
Official Title
Collaborative Self-Management Patient Education Will Improve Health Outcomes in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Pfizer, GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case Management and Self-Management Education
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Case Management and Self-Management Education
Intervention 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.
Primary Outcome Measure Information:
Title
COPD Assessment Test (CAT)
Description
COPD related quality of life measure in primary care.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Health Care Utilization for Emergency Department visits proportion and rate per year
Description
The proportion of subjects that utilized the Emergency for a COPD exacerbation
Time Frame
1 year
Title
Health Care Utilization for Hospital Admission proportion and rate per year
Description
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
Title
Severe Exacerbation proportion and rate per year
Description
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
Other Pre-specified Outcome Measures:
Title
Quality of Life
Description
Improvement of Quality of Life using the CAT score(COPD Assessment Test)
Time Frame
1 year
Title
Improvement in Knowledge of COPD and confidence in self-management
Description
Improvement in Bristol COPD Knowledge Questionnaire and patient self report
Time Frame
1 year
Title
Process of Care
Description
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
Time Frame
1 year
Title
Dyspnea Improvement
Description
Change in dyspnea using the modified MRC questionnaire - Medical Research Council (MRC).
Time Frame
1 year
Title
Disease control
Description
Disease control using the Clinical COPD questionnaire (CCQ)
Time Frame
1 year
Title
Symptom Profile
Description
Change in Symptom profile (cough, wheeze, sputum production)
Time Frame
1 year
Title
Forced Expiratory Volume at 1sec (FEV1) % predicted
Description
FEV1
Time Frame
1 year
Title
Proportion of Patients on therapy appropriate to their stage of disease
Description
Evaluate medication prescribed related to stage of disease
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Licskai
Organizational Affiliation
Lawson Health Research Institution
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amherstburg FHT
City
Amherstburg
State/Province
Ontario
ZIP/Postal Code
N9V 0B4
Country
Canada
Facility Name
Chatham-Kent FHT
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L 5K5
Country
Canada
Facility Name
Harrow FHT
City
Harrow
State/Province
Ontario
ZIP/Postal Code
NOR 1G0
Country
Canada
Facility Name
Leamington FHT
City
Leamington
State/Province
Ontario
ZIP/Postal Code
N8H 1N8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30923313
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.
Results Reference
derived
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COPE With COPD Trial
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