Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients

Asthma Clinical Trial

— ECENVIR  

Official title:

Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients (ECENVIR Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212483
• Other study ID #: 35RC12_9713_ECENVIR
• Secondary ID: 2012-A01414-3912
• Status: Completed
• Phase: N/A
• Start date: September 5, 2014
• Est. completion date: March 5, 2020

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 5, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• First home intervention with advice
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, audit and advices.
• First home intervention without any advice
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, home audit but without any advice.
• Final home visit
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.

Locations

Country	Name	City	State
France	Aix-en-Provence Hospital	Aix-en-Provence
France	Bordeaux University Hospital	Bordeaux
France	Caen University Hospital	Caen
France	Chalon	Chalon-sur-Saone
France	Chauny Hospital	Chauny
France	Dijon University Hospital	Dijon
France	Grenoble University Hospital	Grenoble
France	Lille UH	Lille
France	Macon Hospital	Macon
France	Marseille European Hospital	Marseille
France	Marseille University Hospital	Marseille
France	Nantes University Hospital	Nantes
France	Reims University Hospital	Reims
France	Rouen University Hospital	Rouen
France	Strasbourg UH	Strasbourg	Alsace
France	Vire Hospital	Vire

Sponsors (4)

Lead Sponsor	Collaborator
Rennes University Hospital	Ecole des Hautes Etudes en Santé Publique, Institut de Recherche et Documentation en Economie de la Santé, France, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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/s110 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic pressure versus asthma control	The primary objective of this study is to assess the efficacy of home interventions of MIECs on asthma control.	12 months
Secondary	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.	12 months
Secondary	Advices compliance	One of the secondary objectives is to compare the following after home interventions of MIECs : compliance with advices of MIECs.	12 months
Secondary	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.	12 months
Secondary	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.	12 months