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

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ClinicalTrials.gov Identifier: NCT02212483
Recruitment Status : Active, not recruiting
First Posted : August 8, 2014
Last Update Posted : May 2, 2019
Sponsor:
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
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment Phase
Asthma Other: First home intervention with advice Other: First home intervention without any advice Other: Final home visit Not Applicable

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.

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients (ECENVIR Study)
Study Start Date : September 5, 2014
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 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.
Other: First home intervention with advice
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, audit and advices.

Other: 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.


Active Comparator: 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.

Other: 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.

Other: 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.
Other: 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.





Primary Outcome Measures :
  1. Therapeutic pressure versus asthma control [ Time Frame: 12 months ]
    The primary objective of this study is to assess the efficacy of home interventions of MIECs on asthma control.


Secondary Outcome Measures :
  1. Drug consumption and medical care [ Time Frame: 12 months ]
    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.

  2. Advices compliance [ Time Frame: 12 months ]
    One of the secondary objectives is to compare the following after home interventions of MIECs : compliance with advices of MIECs.

  3. Quality of life questionnaire [ Time Frame: 12 months ]
    One of the secondary objectives is to compare the following after home interventions of MIECs : quality of life before and after home intervention.

  4. Indoor pollutants concentrations [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 24 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 (> 0.35 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 during the last 24 months) 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 year before inclusion during a home intervention of a MIEC
  • smokers with a consumption of more than 10 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212483


Locations
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France
Strasbourg UH
Strasbourg, Alsace, France
Aix-en-Provence Hospital
Aix-en-Provence, France, 13616
Caen University Hospital
Caen, France, 14033
Chalon
Chalon-sur-Saone, France, 71100
Chauny Hospital
Chauny, France
Dijon University Hospital
Dijon, France, 21079
Grenoble University Hospital
Grenoble, France, 38700
Lille UH
Lille, France
Macon Hospital
Macon, France, 71018
Marseille University Hospital
Marseille, France, 13915
Montpellier University Hospital
Montpellier, France, 34295
Nantes University Hospital
Nantes, France, 44093
Trousseau Hospital
Paris, France, 75012
Necker Hospital
Paris, France, 75015
Vire Hospital
Vire, France, 14504
Sponsors and Collaborators
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
Investigators
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Principal Investigator: Jean-Pierre Gangneux, MD Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02212483     History of Changes
Other Study ID Numbers: 35RC12_9713_ECENVIR
2012-A01414-39 ( Other Identifier: ID RCB )
12/42-875 ( Other Identifier: CPP )
13.424 ( Other Identifier: CCTIRS )
913428 ( Other Identifier: CNIL )
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Keywords provided by Rennes University Hospital:
Asthma
Medical Indoor Environment Counselors
Pediatric
Environment
Clinical effectiveness
Economical impact
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases