Evaluation of Efficacy and Tolerance of JOE on 4 to 11 Years Old Asthmatic Patients of GINA Grade 2,3 or 4.

Study Overview
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Brief Summary
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The main objective of this study is to evaluate efficacy and safety of patient's learning in self-taking of prescribed treatments and provided by JOE, on the number of severe exacerbations in children with an asthma graded 2, 3 or 4 according to GINA classification.

Detailed Description
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A new device, named JOE, manufactured by Ludocare, is available since 2019 in France. This new device, compact and connected, was designed to be easy to use by children suffering from chronic disease. JOE is a robot designed to improve compliance with chronic treatments. To confirm efficacy and safety of a patient's learning in self-taking of prescribed treatments provided by JOE, it has been decided to carry out a clinical study in 4 to 11 years old patients and suffering from asthma graded 2, 3 or 4 according to GINA classification. These patients will be recruited by pneumo-pediatricians at hospital or in private practice. The study is a phase 3, multi-center, prospective, open, 2-parallel groups, randomized and controlled study. Each patient will be randomly allocated in one of two studied treatment groups: standard chronic treatments (group SCT) vs standard chronic treatments + JOE robot(group SCT + JOE). Patients meeting eligible criteria will be included at Day 0 (Visit V0). For each patient the maximal duration of this study will be 12 months. At day 7 a phone call is planned to evaluate patient/parent's motivation and to detect potential technical and/or therapeutic problems. Three visits are planned then after at4 (M4), 8 (M8)and 12 (M12)months.

Official Title
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Phase 3, Multi-centre, Prospective, Open, Randomized, in Two Parallel Groups Study to Evaluate Efficacy and Tolerance of Patient's Learning in Self-taking of Prescribed Treatments and Provided by a Robot Named JOE.

Conditions
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Asthma in Children

Intervention / Treatment
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* Device: JOE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4-11years old, able to use JOE persistent uncontrolled asthma, graded 2, 3 or 4 on GINA classification maintenance treatment since at least 3 months having given their informed written consent Exclusion Criteria: asthma naïve-treatment child without regular follow-up with the investigator participating to another interventional study, with another disease, other treatments or planned modification of prescribed treatments that could interfere with studied disease

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard + JOE<br>Standard Maintenance Treatment plus JOE robot | Device: JOE<br>* Audiovisual support by the robot when taking maintenance treatments at home.<br>|
| No Intervention: Standard<br>Standard maintenance Treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the mean number of exacerbations per patient between the two treatment groups during the 12-month follow-up. | Evaluation of patient's learning in self-taking of prescribed treatments and provided by robot companion JOE on number of severe exacerbations needing systemic corticoids. Comparison, between both treatment groups, of number of severe exacerbations over 12 months of follow-up. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the maintenance treatment measured with c-ACT | Effect of the educational support for the patient when taking treatments and provided by the JOE companion robot on the maintenance treatment effectiveness measured with c-ACT score at each visit. | 12 months | 
| Tolerance to the maintenance treatment evaluated by the number and type of adverse events | Effect of the educational support for the patient when taking treatments and provided by the JOE companion robot on the tolerance of the maintenance treatment evaluated by the number and type of the adverse events declared to the investigator. | 12 months | 
| Global costs estimation evaluated by price | Evaluation of the global treatment costs, including the treatment of intercurrent events linked to the disease and their possible consequences (unplanned medical consultations, hospitalizations...). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adherence