Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
NCT ID: NCT02212483
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2014-09-05
2020-03-05
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
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.
The Control group will still be described.
Study Groups
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Intervention group
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.
First home intervention with advice
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, audit and advices.
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.
Control group
The " control group " is one of the two comparative groups 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.
This group has been suppressed with the last amendment. But data of the subjects included in this group will be analyzed.
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.
Non intervention group
The " non intervention " group is the second comparative group with no initial visit, but will benefit from a complete home intervention of a MIEC at the end of the study.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
44 Years
ALL
No
Sponsors
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Ecole des Hautes Etudes en Santé Publique
OTHER
Institut de Recherche et Documentation en Economie de la Santé, France
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jean-Pierre Gangneux, MD
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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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
Marseille University Hospital
Marseille, , France
Macon Hospital
Mâcon, , France
Nantes University Hospital
Nantes, , France
Reims University Hospital
Reims, , France
Rouen University Hospital
Rouen, , France
Vire Hospital
Vire, , France
Countries
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References
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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.
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.
Other Identifiers
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2012-A01414-39
Identifier Type: OTHER
Identifier Source: secondary_id
12/42-875
Identifier Type: OTHER
Identifier Source: secondary_id
13.424
Identifier Type: OTHER
Identifier Source: secondary_id
913428
Identifier Type: OTHER
Identifier Source: secondary_id
35RC12_9713_ECENVIR
Identifier Type: -
Identifier Source: org_study_id
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