COPE With COPD Trial | NCT02343055

NCT02343055

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Pfizer	INDUSTRY
GlaxoSmithKline	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case Management and Self-Management Education	Experimental	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
Usual Care	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Case Management and Self-Management Education	Other	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.

Outcomes Module

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Name	Affiliation	Role
Christopher Licskai	Lawson Health Research Institution	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Amherstburg FHT		Amherstburg	Ontario	N9V 0B4	Canada
Chatham-Kent FHT

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30923313	Derived	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.

IPD Sharing Statement Module

Condition Browse Module

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Intervention Browse Module

ID	Term
D019090	Case Management

ID	Term
D010347	Patient Care Planning
D003191	Comprehensive Health Care
D010346	Patient Care Management
D006298	Health Services Administration

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.