Clinical trial NCT00542061: Monitoring Asthma and COPD in Primary 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases, Obstructive
Asthma
Keywords: COPD
Asthma
Lung function
Monitoring
Primary Care
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: PICASSO: Partners in Care Solutions for COPD
First posted: 2007-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

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 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

Primary outcomes:
measure: Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR)
timeFrame: At baseline, after one year follow-up, and after two years follow-up
Secondary outcomes:
measure: 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.
timeFrame: Yearly: SF12, MRC, exacerbations; At baseline and end of the trial: EuroPEP, lung function indices; Continues by general practitioner registration: costs and exacerbations
measure: Moreover special attention will be paid to process evaluation (e.g, compliance to recommendations by general practitioner and patients).
timeFrame: half-yearly for general practitioners and yearly for patients
Other outcomes:
Locations:
city: Etten-Leur
country: Netherlands
facility: Regional Diagnostic Centre, Etten-Leur, The Netherlands (SHL)
Study officials:
affiliation: Radboud University Nijmegen Medical Centre, department of general practice
name: Tjard Schermer, PhD
role: STUDY_DIRECTOR
affiliation: Radboud University Nijmegen Medical Centre, department of general practice
name: Lisette van den Bemt, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Nijmegen Medical Centre, department of general practice
name: Chris van Weel, MD PhD professor
role: STUDY_CHAIR
References:
citation: 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.