Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
ECENVIR
5 other identifiers
interventional
107
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Sep 2014
Longer than P75 for not_applicable asthma
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2014
CompletedFirst Posted
Study publicly available on registry
August 8, 2014
CompletedStudy Start
First participant enrolled
September 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2020
CompletedMay 24, 2023
May 1, 2023
4.3 years
August 5, 2014
May 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Drug consumption and medical care
12 months
Advices compliance
12 months
Quality of life questionnaire
12 months
Indoor pollutants concentrations
12 months
Study Arms (3)
Intervention group
EXPERIMENTALAfter 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 COMPARATORThe " 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
OTHERThe " 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.
Interventions
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, audit and advices.
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, home audit but without any advice.
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
You may qualify if:
- 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)
You may not qualify if:
- chronic obstructive pulmonary disease (COPD),
- identified occupational asthma,
- 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,
- Major people being the object of a legal protection (protection(saving) of justice, guardianship, supervision(guardianship)) and private persons of freedom
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Strasbourg UH
Strasbourg, Alsace, France
Aix-en-Provence Hospital
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
Related Publications (2)
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.
PMID: 27665387RESULTGangneux 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.
PMID: 31897973RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Pierre Gangneux, MD
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2014
First Posted
August 8, 2014
Study Start
September 5, 2014
Primary Completion
December 31, 2018
Study Completion
March 5, 2020
Last Updated
May 24, 2023
Record last verified: 2023-05