Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

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.
    

Intervention name(s): First home intervention with advice; First home intervention without any advice; Final home visit
Intervention type(s): Other; Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Asthma; Medical Indoor Environment Counselors; Pediatric; Environment; Clinical effectiveness; Economical impact