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COPE With COPD Trial

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ClinicalTrials.gov Identifier: NCT02343055
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : July 30, 2018
Sponsor:
Collaborators:
Pfizer
GlaxoSmithKline
Information provided by (Responsible Party):
Lawson Health Research Institute

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.

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Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Case Management and Self-Management Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Collaborative Self-Management Patient Education Will Improve Health Outcomes in COPD
Study Start Date : October 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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.




Primary Outcome Measures :
  1. COPD Assessment Test (CAT) [ Time Frame: 1 Year ]
    COPD related quality of life measure in primary care.


Secondary Outcome Measures :
  1. Health Care Utilization for Emergency Department visits proportion and rate per year [ Time Frame: 1 year ]
    The proportion of subjects that utilized the Emergency for a COPD exacerbation

  2. Health Care Utilization for Hospital Admission proportion and rate per year [ Time Frame: 1 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.

  3. Severe Exacerbation proportion and rate per year [ Time Frame: 1 year ]
    The proportion of subjects experiencing one or more exacerbations in the study interval. An exacerbation diary will be completed for each event.


Other Outcome Measures:
  1. Quality of Life [ Time Frame: 1 year ]
    Improvement of Quality of Life using the CAT score(COPD Assessment Test)

  2. Improvement in Knowledge of COPD and confidence in self-management [ Time Frame: 1 year ]
    Improvement in Bristol COPD Knowledge Questionnaire and patient self report

  3. Process of Care [ Time Frame: 1 year ]
    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

  4. Dyspnea Improvement [ Time Frame: 1 year ]
    Change in dyspnea using the modified MRC questionnaire - Medical Research Council (MRC).

  5. Disease control [ Time Frame: 1 year ]
    Disease control using the Clinical COPD questionnaire (CCQ)

  6. Symptom Profile [ Time Frame: 1 year ]
    Change in Symptom profile (cough, wheeze, sputum production)

  7. Forced Expiratory Volume at 1sec (FEV1) % predicted [ Time Frame: 1 year ]
    FEV1

  8. Proportion of Patients on therapy appropriate to their stage of disease [ Time Frame: 1 year ]
    Evaluate medication prescribed related to stage of disease



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343055


Locations
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Canada, Ontario
Amherstburg FHT
Amherstburg, Ontario, Canada, N9V 0B4
Chatham-Kent FHT
Chatham, Ontario, Canada, N7L 5K5
Harrow FHT
Harrow, Ontario, Canada, NOR 1G0
Leamington FHT
Leamington, Ontario, Canada, N8H 1N8
Sponsors and Collaborators
Lawson Health Research Institute
Pfizer
GlaxoSmithKline
Investigators
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Principal Investigator: Christopher Licskai Lawson Health Research Institution
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02343055    
Other Study ID Numbers: 00000941
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: April 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases