Regional Diagnostic Centre, Etten-Leur, The Netherlands (SHL)
Etten-Leur, Netherlands
NCT Number: NCT00542061
The purpose of this study is to determine the clinical effectiveness and cost-effectiveness of a written expert advice for GPs on additional diagnostic, treatment, and referral of patients based on half-yearly monitoring routines for patients with COPD or ashtma with a persistent obstruction in primary care based on a multicentre randomised nested clinical trial
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Notify Me25 year and older
All sexes
Interventional
Not applicable
Etten-Leur, Netherlands
In the Netherlands, the majority of patients (60-80 %) with asthma or COPD are treated in primary care, primarily by General Practitioners (GPs). In 1995 a Regional Diagnostic Centre, Etten-Leur, The Netherlands (also called SHL: Stichting Huisartsen Laboratorium) started a lung function monitoring service for patients with asthma and COPD of GPs in the region. The GP receives recommendations on treatment, additional diagnostics and referrals of the patient based on extensive anamnesis (i.e. dyspnoea, symptoms, smoking stage), measurement of lung function, and BMI. Moreover,the general practitioners are supported by an Asthma/COPD nurse that visit the general practice half-yearly.
Main research question of this study: Is a written expert advice for GPs on additional diagnostic, treatment, and referral of patients based on half-yearly monitoring of patients with COPD or asthma with a persistent airway obstruction with support of an AC nurse consultant related to less impaired health related quality of life (HRQoL), less symptoms and better lung function of the patients compared to usual care?
A multi-centre, single blinded (patient, lung function assistant, advisor, and research team are blinded), parallel group study is carried out to compare the monitoring intervention with usual care during 24 months. General practices were allocated by a minimisation procedure and all participating patients of a general practice were allocated to the same treatment group (nested design).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A written expert advice for GPs on additional diagnostic, treatment, and referral of patients with asthma and COPD based on half-yearly monitoring routines (lung function assessments including extensive anamnese) supported by half-yearly visits of an AC nurse consultant to the general practices.
Time frame: At baseline, after one year follow-up, and after two years follow-up
Time frame: Yearly: SF12, MRC, exacerbations; At baseline and end of the trial: EuroPEP, lung function indices; Continues by general practitioner registration: costs and exacerbations
Time frame: half-yearly for general practitioners and yearly for patients
Radboud University Medical Center
Other
Clinical Effectiveness and Cost-effectiveness of a Monitoring System for Patients With COPD and Asthma With Persistent Obstruction in Primary Care; a Multicentre Randomised Nested Clinical Trial
Acronym: Monaco
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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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