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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
First home intervention with advice
First home intervention without any advice
Final home visit
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Asthma, Medical Indoor Environment Counselors, Pediatric, Environment, Clinical effectiveness, Economical impact

Eligibility Criteria

6 Years - 44 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Strasbourg UH
  • Aix-en-Provence Hospital
  • Bordeaux University Hospital
  • Caen University Hospital
  • Chalon
  • Chauny Hospital
  • Dijon University Hospital
  • Grenoble University Hospital
  • Lille UH
  • Macon Hospital
  • Marseille European Hospital
  • Marseille University Hospital
  • Nantes University Hospital
  • Reims University Hospital
  • Rouen University Hospital
  • Vire Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Intervention group

Control group

Non intervention group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Therapeutic pressure versus asthma control
The primary objective of this study is to assess the efficacy of home interventions of MIECs on asthma control.

Secondary Outcome Measures

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.
Advices compliance
One of the secondary objectives is to compare the following after home interventions of MIECs : compliance with advices of MIECs.
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.
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.

Full Information

First Posted
August 5, 2014
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT02212483
Brief Title
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
Acronym
ECENVIR
Official Title
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients (ECENVIR Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2014 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Medical Indoor Environment Counselors, Pediatric, Environment, Clinical effectiveness, Economical impact

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non intervention group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
First home intervention with advice
Intervention Description
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, audit and advices.
Intervention Type
Other
Intervention Name(s)
First home intervention without any advice
Intervention Description
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, home audit but without any advice.
Intervention Type
Other
Intervention Name(s)
Final home visit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Therapeutic pressure versus asthma control
Description
The primary objective of this study is to assess the efficacy of home interventions of MIECs on asthma control.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Drug consumption and medical care
Description
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
Title
Advices compliance
Description
One of the secondary objectives is to compare the following after home interventions of MIECs : compliance with advices of MIECs.
Time Frame
12 months
Title
Quality of life questionnaire
Description
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
Title
Indoor pollutants concentrations
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Gangneux, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Strasbourg UH
City
Strasbourg
State/Province
Alsace
Country
France
Facility Name
Aix-en-Provence Hospital
City
Aix-en-Provence
ZIP/Postal Code
13616
Country
France
Facility Name
Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Chalon
City
Chalon-sur-Saone
ZIP/Postal Code
71100
Country
France
Facility Name
Chauny Hospital
City
Chauny
Country
France
Facility Name
Dijon University Hospital
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38700
Country
France
Facility Name
Lille UH
City
Lille
Country
France
Facility Name
Macon Hospital
City
Macon
ZIP/Postal Code
71018
Country
France
Facility Name
Marseille European Hospital
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Marseille University Hospital
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Reims University Hospital
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Vire Hospital
City
Vire
ZIP/Postal Code
14504
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27665387
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.
Results Reference
result
PubMed Identifier
31897973
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.
Results Reference
result

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

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