Asthma is one of the most prevalent chronic respiratory diseases, with potential lifethreatening impacts. Indeed, asthma is still responsible for about a thousand deceases per year in France, and constitutes a public health problem in our country as in many countries in the world. The economic burden of asthma is also very high, in terms of health care, and indirect costs including lost work and lost school days. A few international and French studies have shown a positive clinical impact of Medical Indoor Environment Counselors (MIECs) visiting homes of asthma patients, mainly pediatrics. It has been proposed that MIECs could contribute to reduce patient exposure to many allergens and irritants, among them, house dust mite allergens, formaldehyde or molds. Most of the studies that show a significant decrease of hospitalization or visit in an emergency ward for asthma are monocentric and study the eviction of 1 such identified risk factor. By contrast, meta-analysis underline that additional studies are needed to evaluate the effectiveness of these interventions in adults, in a multicentric and controlled manner, with both clinical, environmental and economical endpoints.
Methodology/Study schedule : A prospective multicenter randomised, open label, controlled trial with blind evaluation of the primary evaluation criterion on three parallel groups of patients. Procedures : Home intervention of MIECs that comprise diagnostic of allergen/irritant exposure (after sampling), advices for allergen/irritant avoidance and follow up of advice compliance. After randomisation and agreement of the patient and the family, the " intervention group " will benefit from a first home intervention of a MIEC during the 4 weeks following inclusion, then a final visit at the end of the study after 12 months. Two comparative groups will be identified : * the " control group " who will benefit from a first home intervention of a MIEC but without advices (only audit + sampling), then a final and a complete visit at the end of the study * a " non intervention " group with no initial visit, but who will benefit from a complete home intervention of a MIEC at the end of the study. Substantial modification of the 20th of June, 2016 : Modification of the design : change into a 2 parallel groups evaluation Justification: At its meeting of June 1, 2016, considering the inclusion difficulties, the Scientific Council decided to give up the "Control" group. The study design is then : a prospective multicenter randomised, open label, controlled trial with blind evaluation of the primary evaluation criterion on three parallel groups of patients. The objective is to recruit 50 to 70 patients by arm. Expected findings and impact : If our hypothesis that home intervention of MIECs are cost-effective on asthma control, then it is relevant to include such service in the medical care during the management of asthma patients with a reimbursement by the social security.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
107
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, audit and advices.
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, home audit but without any advice.
Final home visit at the end of the study after 12 months, with sampling and home audit. For the "intervention group", checking of the advice compliance. For the both comparative groups, delivery of advices.
Strasbourg UH
Strasbourg, Alsace, France
Aix-en-Provence Hospital
Aix-en-Provence, France
Bordeaux University Hospital
Bordeaux, France
Caen University Hospital
Caen, France
Chalon
Chalon-sur-Saône, France
Chauny Hospital
Chauny, France
Dijon University Hospital
Dijon, France
Grenoble University Hospital
Grenoble, France
Lille UH
Lille, France
Marseille European Hospital
Marseille, France
...and 6 more locations
Therapeutic pressure versus asthma control
The primary objective of this study is to assess the efficacy of home interventions of MIECs on asthma control.
Time frame: 12 months
Drug consumption and medical care
One of the secondary objectives is to compare the following after home interventions of MIECs, evolution of drug consumption and medical care needed by asthmatic patients.
Time frame: 12 months
Advices compliance
One of the secondary objectives is to compare the following after home interventions of MIECs : compliance with advices of MIECs.
Time frame: 12 months
Quality of life questionnaire
One of the secondary objectives is to compare the following after home interventions of MIECs : quality of life before and after home intervention.
Time frame: 12 months
Indoor pollutants concentrations
One of the secondary objectives is to compare the following after home interventions of MIECs : evolution of exposure to indoor pollutants in the intervention group.
Time frame: 12 months
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