Asthma in Children
Conditions
Keywords
Asthma, Children, Prevention, Severe Asthma Exacerbations
Brief summary
The main objective of this study is to evaluate efficacy and safety of patient's learning in self-taking of prescribed asthma maintenance treatments and provided by JOE (a new DTX), on the number of severe exacerbations in children with an asthma graded 2, 3, 4 and 5 according to GINA classification.
Detailed description
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 asthama maintenance treatments.To confirm efficacy and safety of a patient's learning in self-taking of asthma maintenance 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, 4 or 5 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 asthma maintenace treatment (group SCT) vs standard asthma maintenance treatment + JOE (a new DTx) (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.
Interventions
DEVICEJOE
Audiovisual support by the robot when taking maintenance treatments at home.
Sponsors
Clinact
Ludocare SAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analysis performed on anonymous database.
Intervention model description
Two parallel groups: Standard Asthma Maintenance Treatment (SAMT) vs SAMT + Joe robot (a new DTX)
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* 4-11years old, * able to use JOE * persistent uncontrolled asthma, graded 2, 3 , 4 or 5 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the mean number of severe asthma exacerbations per patient between the two treatment groups during the 12-month follow-up. | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the maintenance treatment measured with c-ACT | 12 months | 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. |
| Tolerance to the maintenance treatment evaluated by the number and type of adverse events | 12 months | 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. |
| Global costs estimation evaluated by price | 12 months | Evaluation of the global treatment costs, including the treatment of intercurrent events linked to the disease and their possible consequences (unplanned medical consultations, hospitalizations...). |
Countries
France
Outcome results
None listed