Monitoring Asthma and COPD in Primary Care (Monaco)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||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|
- Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR) [ Time Frame: At baseline, after one year follow-up, and after two years follow-up ]
- Number of exacerbations; generic HRQoL (SF12); lung function indices; level of respiratory symptoms (MRC); satisfaction with the health care received (EuroPep); direct and indirect medical costs. [ 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 ]
- Moreover special attention will be paid to process evaluation (e.g, compliance to recommendations by general practitioner and patients). [ Time Frame: half-yearly for general practitioners and yearly for patients ]
|Study Start Date:||March 2005|
|Study Completion Date:||April 2008|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
Device: monitoring services
Device: half-yearly monitoring routine
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.
No Intervention: B
Control group: no monitoring procedures
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542061
|Regional Diagnostic Centre, Etten-Leur, The Netherlands (SHL)|
|Study Director:||Tjard Schermer, PhD||Radboud University Nijmegen Medical Centre, department of general practice|
|Principal Investigator:||Lisette van den Bemt, MSc||Radboud University Nijmegen Medical Centre, department of general practice|
|Study Chair:||Chris van Weel, MD PhD professor||Radboud University Nijmegen Medical Centre, department of general practice|