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COPE With COPD Trial

26. juli 2018 opdateret af: Lawson Health Research Institute

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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Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

182

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Amherstburg, Ontario, Canada, N9V 0B4
        • Amherstburg FHT
      • Chatham, Ontario, Canada, N7L 5K5
        • Chatham-Kent FHT
      • Harrow, Ontario, Canada, NOR 1G0
        • Harrow FHT
      • Leamington, Ontario, Canada, N8H 1N8
        • Leamington FHT

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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 komparator: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
COPD Assessment Test (CAT)
Tidsramme: 1 Year
COPD related quality of life measure in primary care.
1 Year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health Care Utilization for Emergency Department visits proportion and rate per year
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Life
Tidsramme: 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
Tidsramme: 1 year
Improvement in Bristol COPD Knowledge Questionnaire and patient self report
1 year
Process of Care
Tidsramme: 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
Tidsramme: 1 year
Change in dyspnea using the modified MRC questionnaire - Medical Research Council (MRC).
1 year
Disease control
Tidsramme: 1 year
Disease control using the Clinical COPD questionnaire (CCQ)
1 year
Symptom Profile
Tidsramme: 1 year
Change in Symptom profile (cough, wheeze, sputum production)
1 year
Forced Expiratory Volume at 1sec (FEV1) % predicted
Tidsramme: 1 year
FEV1
1 year
Proportion of Patients on therapy appropriate to their stage of disease
Tidsramme: 1 year
Evaluate medication prescribed related to stage of disease
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Lawson Health Research Institute

Samarbejdspartnere

GlaxoSmithKline
Pfizer

Efterforskere

  • Ledende efterforsker: Christopher Licskai, Lawson Health Research Institution

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2011

Primær færdiggørelse (Faktiske)

1. januar 2015

Studieafslutning (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først indsendt

22. oktober 2014

Først indsendt, der opfyldte QC-kriterier

20. januar 2015

Først opslået (Skøn)

21. januar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juli 2018

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 00000941

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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