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Completed

NCT Number: NCT02343055

COPE With COPD Trial

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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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amherstburg FHT, Amherstburg, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. COPD Assessment Test (CAT)

    Time frame: 1 Year

    COPD related quality of life measure in primary care.

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • GlaxoSmithKline
  • Pfizer

Registry information

Official study title

Collaborative Self-Management Patient Education Will Improve Health Outcomes in COPD

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 21, 2015
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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