Monitoring Asthma and COPD in Primary Care (Monaco)

March 8, 2010 updated by: Radboud University Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Etten-Leur, Netherlands
        • Regional Diagnostic Centre, Etten-Leur, The Netherlands (SHL)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At baseline, after one year follow-up, and after two years follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
half-yearly for general practitioners and yearly for patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

February 1, 2007

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

October 8, 2007

First Submitted That Met QC Criteria

October 8, 2007

First Posted (ESTIMATE)

October 10, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2010

Last Update Submitted That Met QC Criteria

March 8, 2010

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Picasso 04-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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