- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02343055
COPE With COPD Trial
Collaborative Self-Management Patient Education Will Improve Health Outcomes in COPD
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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Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
Ontario
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Amherstburg, Ontario, Kanada, N9V 0B4
- Amherstburg FHT
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Chatham, Ontario, Kanada, N7L 5K5
- Chatham-Kent FHT
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Harrow, Ontario, Kanada, NOR 1G0
- Harrow FHT
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Leamington, Ontario, Kanada, N8H 1N8
- Leamington FHT
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: 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.
|
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.
|
Komparator placebo: 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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
COPD Assessment Test (CAT)
Ramy czasowe: 1 Year
|
COPD related quality of life measure in primary care.
|
1 Year
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Health Care Utilization for Emergency Department visits proportion and rate per year
Ramy czasowe: 1 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
Ramy czasowe: 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.
|
1 year
|
Severe Exacerbation proportion and rate per year
Ramy czasowe: 1 year
|
The proportion of subjects experiencing one or more exacerbations in the study interval.
An exacerbation diary will be completed for each event.
|
1 year
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Quality of Life
Ramy czasowe: 1 year
|
Improvement of Quality of Life using the CAT score(COPD Assessment Test)
|
1 year
|
Improvement in Knowledge of COPD and confidence in self-management
Ramy czasowe: 1 year
|
Improvement in Bristol COPD Knowledge Questionnaire and patient self report
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1 year
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Process of Care
Ramy czasowe: 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
|
1 year
|
Dyspnea Improvement
Ramy czasowe: 1 year
|
Change in dyspnea using the modified MRC questionnaire - Medical Research Council (MRC).
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1 year
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Disease control
Ramy czasowe: 1 year
|
Disease control using the Clinical COPD questionnaire (CCQ)
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1 year
|
Symptom Profile
Ramy czasowe: 1 year
|
Change in Symptom profile (cough, wheeze, sputum production)
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1 year
|
Forced Expiratory Volume at 1sec (FEV1) % predicted
Ramy czasowe: 1 year
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FEV1
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1 year
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Proportion of Patients on therapy appropriate to their stage of disease
Ramy czasowe: 1 year
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Evaluate medication prescribed related to stage of disease
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1 year
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Christopher Licskai, Lawson Health Research Institution
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 00000941
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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