Evaluation of an Environmental Counsellor's Home Stay in Children Treated for Asthma or Allergic Rhinitis Via a Standardized Medical Questionnaire Randomized Controlled Superiority Trial in Parallel Arms, Multicentric (EvalPCE)

NCT ID: NCT04927689

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2026-01-15

Brief Summary

Assessment of asthmatic children and children with allergic rhinitis at day 0 and 6 months after a home visit by an environmental consultant via standardized medical questionnaires.

Detailed Description

Asthma and allergic rhinitis are chronic diseases whose control is multifactorial (drug treatment, therapeutic education of the family and the child, consideration of a possible allergen...). When this control is not optimal, it leads to significant school absenteeism, pediatric emergency room visits and hospitalizations. Environmental conditions at home play a role in asthma exacerbations and poor control of allergic rhinitis in children. Mites, animal allergens, passive smoking, molds, cockroaches, household products, etc., are the main causes. The visit of a home environment advisor, who intervenes on medical prescription, makes it possible to evaluate the source of allergens and pollutants in the home and then to propose changes to the home. This position was created in France in 2009 by the Ministry of the Environment and is funded by the Agence Régional de Santé (ARS - Regional Health Agency). The few studies carried out to assess the effectiveness of a home visit by an environmental advisor on exacerbations of these diseases are contradictory: some show an improvement in the quality of life of asthmatic children after a home visit (via the average reduction in the number of days with symptoms/year) as well as a reduction in asthma-related morbidity thanks to a reduction in exposure to indoor allergens. Others have shown that it does not reduce the number of emergency room visits for asthma exacerbations. Furthermore, it would appear that targeted allergen avoidance measures do not reduce drug treatment in asthmatics who are already on optimal pharmacological treatment.

To our knowledge, there are no studies in France that use standardized medical questionnaires to assess disease control and quality of life before and after the visit of a home environmental consultant. For example, in Angers and Nantes, evaluation questionnaires are carried out with patients at 6 months and 1 year after a home visit, but the answers are not standardized and sometimes very subjective.

Conditions

Category 3 Study (Non-interventional Research)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patient under 18 years of age
• With asthma or allergic rhinitis
• For whom a home visit by an environmental consultant is prescribed

Exclusion Criteria

• Parental refusal to participate in the study
• Poor understanding of the French language not allowing to fill in the questionnaire
• Asthmatic child under 7 years old or child with allergic rhinitis under 6 years old (questionnaires not validated below these ages)
• Patient concerned by a current request for relocation

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CARBALLIDO

Role: STUDY_DIRECTOR

University Hospital, Angers

Locations

CHU Angers

Angers, , France

Countries

France

Other Identifiers

49RC21_0186

Identifier Type: -

Identifier Source: org_study_id