Monitoring Asthma and COPD in Primary Care (Monaco)

This study has been completed.
Sponsor:
Collaborator:
PICASSO: Partners in Care Solutions for COPD
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00542061
First received: October 8, 2007
Last updated: March 8, 2010
Last verified: October 2007
  Purpose

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


Condition Intervention
Lung Diseases, Obstructive
Asthma
Device: half-yearly monitoring routine

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: March 2005
Study Completion Date: April 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542061

Locations
Netherlands
Regional Diagnostic Centre, Etten-Leur, The Netherlands (SHL)
Etten-Leur, Netherlands
Sponsors and Collaborators
Radboud University
PICASSO: Partners in Care Solutions for COPD
Investigators
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
  More Information

Additional Information:
No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00542061     History of Changes
Other Study ID Numbers: Picasso 04-008
Study First Received: October 8, 2007
Last Updated: March 8, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
COPD
Asthma
Lung function
Monitoring
Primary Care

Additional relevant MeSH terms:
Asthma
Lung Diseases
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014