COPE With COPD Trial

NCT02343055 | Completed

• 1 other identifier: 00000941
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 4

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. .

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• COPD Assessment Test (CAT)

  COPD related quality of life measure in primary care.

  1 Year

Secondary Outcomes (3)

• Health Care Utilization for Emergency Department visits proportion and rate per year

  1 year

• Health Care Utilization for Hospital Admission proportion and rate per year

  1 year

• Severe Exacerbation proportion and rate per year

  1 year

Other Outcomes (8)

• Quality of Life

  1 year

• Improvement in Knowledge of COPD and confidence in self-management

  1 year

• Process of Care

  1 year

Study Arms (2)

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

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.

Case Management and Self-Management Education; Usual Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current or Ex-smokers
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Pfizer: collaborator
• GlaxoSmithKline: collaborator

Study Sites (4)

Amherstburg FHT

Amherstburg, Ontario, N9V 0B4, Canada

Location

Chatham-Kent FHT

Chatham, Ontario, N7L 5K5, Canada

Location

Harrow FHT

Harrow, Ontario, NOR 1G0, Canada

Location

Leamington FHT

Leamington, Ontario, N8H 1N8, Canada

Location

Related Publications (1)

• 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.

  PMID: 30923313 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Case Management

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Christopher Licskai

  Lawson Health Research Institution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: January 21, 2015
• Study Start: October 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 30, 2018

Record last verified: 2015-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)