Monitoring Asthma and COPD in Primary Care (Monaco)
Primary Purpose
Lung Diseases, Obstructive, Asthma
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
half-yearly monitoring routine
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Diseases, Obstructive focused on measuring COPD, Asthma, Lung function, Monitoring, Primary Care
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
Sites / Locations
- Regional Diagnostic Centre, Etten-Leur, The Netherlands (SHL)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
Device: monitoring services
Control group: no monitoring procedures
Outcomes
Primary Outcome Measures
Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR)
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.
Moreover special attention will be paid to process evaluation (e.g, compliance to recommendations by general practitioner and patients).
Full Information
NCT ID
NCT00542061
First Posted
October 8, 2007
Last Updated
March 8, 2010
Sponsor
Radboud University Medical Center
Collaborators
PICASSO: Partners in Care Solutions for COPD
1. Study Identification
Unique Protocol Identification Number
NCT00542061
Brief Title
Monitoring Asthma and COPD in Primary Care
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
PICASSO: Partners in Care Solutions for COPD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Obstructive, Asthma
Keywords
COPD, Asthma, Lung function, Monitoring, Primary Care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Device: monitoring services
Arm Title
B
Arm Type
No Intervention
Arm Description
Control group: no monitoring procedures
Intervention Type
Device
Intervention Name(s)
half-yearly monitoring routine
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tjard Schermer, PhD
Organizational Affiliation
Radboud University Nijmegen Medical Centre, department of general practice
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lisette van den Bemt, MSc
Organizational Affiliation
Radboud University Nijmegen Medical Centre, department of general practice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris van Weel, MD PhD professor
Organizational Affiliation
Radboud University Nijmegen Medical Centre, department of general practice
Official's Role
Study Chair
Facility Information:
Facility Name
Regional Diagnostic Centre, Etten-Leur, The Netherlands (SHL)
City
Etten-Leur
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19740044
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.
Results Reference
derived
Links:
URL
http://www.umcn.nl
Description
Website Radboud University Nijmegen Medical Centre
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Monitoring Asthma and COPD in Primary Care
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