Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice
21. november 2011 opdateret af: E. Bischoff, Radboud University Medical Center
Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care
In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:
- usual general practitioner (GP) care (at patient's initiative);
- regular practice nurse review; and
- integrated self-management education.
All three interventions are based on existing guidelines, materials, and field experiences.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Considering the ageing of the Dutch population and the current and increasing shortage of general practitioners (GPs), the capacity of primary healthcare is a major and growing concern. Delegation of care normally provided by GPs with care provided by trained practice nurses is now rapidly emerging for patients with chronic respiratory disease, i.e. asthma and chronic obstructive pulmonary disease (COPD). However, most general practices still provide care at initiative of the patient self, because of the lack in scientific evidence and the costs of implementing a regular care structure. Self-care by patients may be an alternative to alleviate the growing load on primary health care.
The following two main research questions are addressed in this study.
- Does an integrated self-management education intervention for patients with COPD in general practice contribute to attaining long-term treatment targets, compared to regular monitoring by a practice nurse and usual GP care?
- What is the cost-effectiveness of an integrated self-management education intervention for patients with COPD, compared to regular monitoring by a practice nurse and usual GP care?
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
165
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Nijmegen, Holland, 6500 HB
- Radboud University, Department of General Medicine
-
-
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
35 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Registered in one of the general practices participating in the study
- Diagnosis of COPD, with Global Initiative for Chronic Obstructive Lung Diseases (GOLD) stage I, II or III
- Age ≥35 years
- Willing to provide written informed consent
Exclusion Criteria:
- Very poor prognosis with regard to respiratory condition (GOLD stage IV)
- Severe co-morbid conditions with a reduced life expectancy
- Unable to communicate in the Dutch language
- Objections to one or more of the disease management modes in the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: usual care
usual care, i.e.
COPD care at patient's own initiative, mostly for medical help during exacerbations
|
care at initiative of the patient (usual GP care)
|
|
Eksperimentel: monitoring controls
regular COPD care (monitoring) provided by practice nurse according to current COPD guidelines
|
protocol based on existing Guidelines: Dutch College of General Practitioners (NHG) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
|
|
Eksperimentel: self-management
disease specific self-management program 'Living Well with COPD'
|
disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
disease-specific health-related quality of life (HRQoL)
Tidsramme: two years
|
two years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
the number of exacerbations
Tidsramme: two years
|
two years
|
|
generic quality of life
Tidsramme: two years
|
two years
|
|
decline post- and pre-bronchodilator (BD) lung function indices
Tidsramme: two years
|
two years
|
|
level of respiratory symptoms
Tidsramme: two years
|
two years
|
|
satisfaction with the health care received
Tidsramme: two years
|
two years
|
|
compliance with (non-) pharmaceutical treatment
Tidsramme: two years
|
two years
|
|
direct and indirect medical costs
Tidsramme: two years
|
two years
|
|
COPD related self-efficacy
Tidsramme: two years
|
two years
|
|
COPD coping styles
Tidsramme: two years
|
two years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Chris van Weel, FRCP, Department of General Practice, Radboud University, Nijmegen, The Netherlands
- Studieleder: Tjard Schermer, PhD, Department of General Practice, Radboud University, Nijmegen, The Netherlands
- Ledende efterforsker: Erik Bischoff, MD, Department of General Practice, Radboud University, Nijmegen, The Netherlands
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
- Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
- Monninkhof E, van der Valk P, van der Palen J, van Herwaarden C, Partridge MR, Zielhuis G. Self-management education for patients with chronic obstructive pulmonary disease: a systematic review. Thorax. 2003 May;58(5):394-8. doi: 10.1136/thorax.58.5.394.
- Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD. Patient Educ Couns. 2004 Mar;52(3):271-7. doi: 10.1016/S0738-3991(03)00102-2.
- Bischoff EW, Akkermans R, Bourbeau J, van Weel C, Vercoulen JH, Schermer TR. Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial. BMJ. 2012 Nov 28;345:e7642. doi: 10.1136/bmj.e7642.
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. januar 2005
Primær færdiggørelse (Faktiske)
1. december 2008
Studieafslutning (Faktiske)
1. december 2008
Datoer for studieregistrering
Først indsendt
9. august 2005
Først indsendt, der opfyldte QC-kriterier
9. august 2005
Først opslået (Skøn)
10. august 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. november 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. november 2011
Sidst verificeret
1. november 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MONC95582
- ZonMw grant: 945.04.230 (Andet bevillings-/finansieringsnummer: ZonMw)
- Picasso grant: 005.2004 (Andet bevillings-/finansieringsnummer: Picasso)
- CMO: 2004/249 (Anden identifikator: Medical Ethics Committee)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .