Monitoring Asthma and COPD in Primary Care

Asthma Clinical Trial

— Monaco  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542061
• Other study ID #: Picasso 04-008
• Status: Completed
• Phase: N/A
• First received: October 8, 2007
• Last updated: March 8, 2010
• Start date: March 2005
• Est. completion date: April 2008

Study information

• Verified date: October 2007
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma
• Lung Diseases
• Lung Diseases, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Regional Diagnostic Centre, Etten-Leur, The Netherlands (SHL)	Etten-Leur

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	PICASSO: Partners in Care Solutions for COPD

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR)		At baseline, after one year follow-up, and after two years follow-up
Secondary	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.		Yearly: SF12, MRC, exacerbations; At baseline and end of the trial: EuroPEP, lung function indices; Continues by general practitioner registration: costs and exacerbations
Secondary	Moreover special attention will be paid to process evaluation (e.g, compliance to recommendations by general practitioner and patients).		half-yearly for general practitioners and yearly for patients

External Links

•   Website Radboud University Nijmegen Medical Centre