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Trial record 1 of 1 for:    NCT02343055
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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

Tracking Information
First Submitted Date  ICMJE October 22, 2014
First Posted Date  ICMJE January 21, 2015
Last Update Posted Date July 30, 2018
Study Start Date  ICMJE October 2011
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
COPD Assessment Test (CAT) [ Time Frame: 1 Year ]
COPD related quality of life measure in primary care.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 20, 2015)
  • Quality of Life [ Time Frame: 1 year ]
    Improvement of Quality of Life using the CAT score(COPD Assessment Test)
  • Improvement in Knowledge of COPD and confidence in self-management [ Time Frame: 1 year ]
    Improvement in Bristol COPD Knowledge Questionnaire and patient self report
  • 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
  • Dyspnea Improvement [ Time Frame: 1 year ]
    Change in dyspnea using the modified MRC questionnaire - Medical Research Council (MRC).
  • Disease control [ Time Frame: 1 year ]
    Disease control using the Clinical COPD questionnaire (CCQ)
  • Symptom Profile [ Time Frame: 1 year ]
    Change in Symptom profile (cough, wheeze, sputum production)
  • Forced Expiratory Volume at 1sec (FEV1) % predicted [ Time Frame: 1 year ]
    FEV1
  • Proportion of Patients on therapy appropriate to their stage of disease [ Time Frame: 1 year ]
    Evaluate medication prescribed related to stage of disease
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE COPE With COPD Trial
Official Title  ICMJE Collaborative Self-Management Patient Education Will Improve Health Outcomes in COPD
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.

.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Case Management and Self-Management Education
  • 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.
    Intervention: Other: Case Management and Self-Management Education
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2015)
182
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02343055
Other Study ID Numbers  ICMJE 00000941
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE
  • Pfizer
  • GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Christopher Licskai Lawson Health Research Institution
PRS Account Lawson Health Research Institute
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP