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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01414-39 | Other Identifier | ID RCB | |
| 12/42-875 | Other Identifier | CPP | |
| 13.424 | Other Identifier | CCTIRS | |
| 913428 | Other Identifier | CNIL |
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| Name | Class |
|---|---|
| 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 |
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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Control group | Active Comparator | 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. |
|
| Non intervention group | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First home intervention with advice | Other | A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, audit and advices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Advices compliance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre Gangneux, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strasbourg UH | Strasbourg | Alsace | France | |||
| Aix-en-Provence Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27665387 | Result | 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. | |
| 31897973 | Result | 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. |
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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.
The Control group will still be described.
| First home intervention without any advice | Other | A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, home audit but without any advice. |
|
| Final home visit | Other | 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. |
|
One of the secondary objectives is to compare the following after home interventions of MIECs : compliance with advices of MIECs.
| 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. | 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. | 12 months |
| Aix-en-Provence |
| 13616 |
| France |
| Bordeaux University Hospital | Bordeaux | 33076 | France |
| Caen University Hospital | Caen | 14033 | France |
| Chalon | Chalon-sur-Saône | 71100 | France |
| Chauny Hospital | Chauny | France |
| Dijon University Hospital | Dijon | 21079 | France |
| Grenoble University Hospital | Grenoble | 38700 | France |
| Lille UH | Lille | France |
| Marseille European Hospital | Marseille | 13003 | France |
| Marseille University Hospital | Marseille | 13915 | France |
| Macon Hospital | Mâcon | 71018 | France |
| Nantes University Hospital | Nantes | 44093 | France |
| Reims University Hospital | Reims | 51100 | France |
| Rouen University Hospital | Rouen | 76000 | France |
| Vire Hospital | Vire | 14504 | France |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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