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Monitoring Asthma and COPD in Primary Care (Monaco)

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ClinicalTrials.gov Identifier: NCT00542061
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : March 9, 2010
Sponsor:
Collaborator:
PICASSO: Partners in Care Solutions for COPD
Information provided by:
Radboud University

October 8, 2007
October 10, 2007
March 9, 2010
March 2005
February 2007   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00542061 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Monitoring Asthma and COPD in Primary Care
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
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

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).

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Lung Diseases, Obstructive
  • Asthma
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.
  • Experimental: A
    Device: monitoring services
    Intervention: Device: half-yearly monitoring routine
  • No Intervention: B
    Control group: no monitoring procedures
van den Bemt L, Schermer TR, Smeele IJ, Boonman-de Winter LJ, van Boxem T, Denis J, Grootens-Stekelenburg JG, Grol RP, van Weel C. An expert-supported monitoring system for patients with chronic obstructive pulmonary disease in general practice: results of a cluster randomised controlled trial. Med J Aust. 2009 Sep 7;191(5):249-54.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Same as current
April 2008
February 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient is categorised as asthmatic disease with persistent airway obstruction or COPD in the monitoring system SHL confirmed by the most recent lung function assessment (FEV1/FVC < 70% after BD and FEV1 ≥ 50% pred after BD) or (FEV1 < 80% predicted after BD and ≥ 9% reversibility)
  • The patient is monitored by the AC service of the SHL.
  • The GP of the patient is willing to participate in the trial.
  • Written informed consent of participant

Exclusion Criteria:

  • Patients treated primary by a pulmonologist
  • Patients currently participating in another respiratory intervention study
  • When the GP considers it detrimental to the patient to participate in the study
  • Serious other non-pulmonary diseases (or disease-stages) that are presumed to lead to "lost to follow-up" because of the severity of the disease course (like diseases with low survival rate or mental deterioration)
  • Serious other pulmonary diseases that effect bronchial symptoms and/or lung function, e.g. sarcoidosis, lung cancer, lung fibrosis
  • Illiteracy
Sexes Eligible for Study: All
25 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00542061
Picasso 04-008
No
Not Provided
Not Provided
Not Provided
Radboud University
PICASSO: Partners in Care Solutions for COPD
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
Radboud University
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP