Asthma Clinical Trial
— MonacoOfficial 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
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
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Netherlands | Regional Diagnostic Centre, Etten-Leur, The Netherlands (SHL) | Etten-Leur |
Lead Sponsor | Collaborator |
---|---|
Radboud University | PICASSO: Partners in Care Solutions for COPD |
Netherlands,
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 |
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