Clinical trial NCT02212483: Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
Official title: Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients (ECENVIR Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Medical Indoor Environment Counselors
Pediatric
Environment
Clinical effectiveness
Economical impact
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ecole des Hautes Etudes en Santé Publique
name: Institut de Recherche et Documentation en Economie de la Santé, France
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2014-08-08
Enrollment: 107
Sex: ALL
Minimum age (years): 6
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age greater than or equal to 6 years and less than 45 (\<45 years),
* patients with an eligible control level of asthma,
* sensitization to one or more allergens demonstrated during the last 36 months with prick tests (papules with a diameter \> 3 mm compared to a negative control or \> 50% of positive control) and/or specific IgE detection (\> 0.10 U/mL),
* patients \> 15 years presenting with a reversibility to ß2-agonists \> 200 mL and/or \> 12% compared to the initial FEV1 value (test performed at least once in life) or patients ≥ 6 years and ≤ 15 years presenting with a reversibility to ß2-agonists \> 200 mL and/or \> 12% compared to the initial FEV1 value (at least once in the life) and/or a positive metacholine challenge (at least once in the life),
* patients sleeping \> 6 nights per week in the same house
* individuals affiliated to 1 of the 3 French social security (for matching data from French social security via SNIIRAM system),
* Only one patient per dwelling,
* Patient oral consent (written attestation by investigator)

Exclusion Criteria:

* chronic obstructive pulmonary disease (COPD),
* identified occupational asthma,
* Move within the 6 months before home intervention or predicted during the first year of inclusion,
* advices provided during the 2 years before inclusion during a home intervention of a MIEC
* active smokers or smoker who given up smoking less than 5 years ago, with a consumption of more than 10 years of 20 cigarettes/day, OR smoker who given up smoking more than 5 years ago, with a consumption of more than 20 years of 20 cigarettes/day,
* patients \< 18 years for whom the parents (or legal guardian) are opposed to the inclusion in ECENVIR study,
* Major people being the object of a legal protection (protection(saving) of justice, guardianship, supervision(guardianship)) and private persons of freedom

Primary outcomes:
measure: Therapeutic pressure versus asthma control
timeFrame: 12 months
Secondary outcomes:
measure: Drug consumption and medical care
timeFrame: 12 months
measure: Advices compliance
timeFrame: 12 months
measure: Quality of life questionnaire
timeFrame: 12 months
measure: Indoor pollutants concentrations
timeFrame: 12 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Strasbourg UH
state: Alsace
city: Aix-en-Provence
country: France
facility: Aix-en-Provence Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Chalon-sur-Saone
country: France
facility: Chalon
city: Chauny
country: France
facility: Chauny Hospital
city: Dijon
country: France
facility: Dijon University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Lille
country: France
facility: Lille UH
city: Macon
country: France
facility: Macon Hospital
city: Marseille
country: France
facility: Marseille European Hospital
city: Marseille
country: France
facility: Marseille University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Reims
country: France
facility: Reims University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Vire
country: France
facility: Vire Hospital
Study officials:
affiliation: Rennes University Hospital
name: Jean-Pierre Gangneux, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Cann P, Paulus H, Glorennec P, Le Bot B, Frain S, Gangneux JP. Home Environmental Interventions for the Prevention or Control of Allergic and Respiratory Diseases: What Really Works. J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):66-79. doi: 10.1016/j.jaip.2016.07.011. Epub 2016 Sep 21.
citation: Gangneux JP, Bouvrais M, Frain S, Morel H, Deguen S, Chevrier S, Le Cann P. Asthma and Indoor Environment: Usefulness of a Global Allergen Avoidance Method on Asthma Control and Exposure to Molds. Mycopathologia. 2020 Apr;185(2):367-371. doi: 10.1007/s11046-019-00417-9. Epub 2020 Jan 2.