Evaluation of Efficacy and Tolerance of JOE on 4 to 11 Years Old Asthmatic Patients of GINA 2,3,4 and 5 Grades
- Conditions
- Asthma in Children
- Interventions
- Device: JOE
- Registration Number
- NCT04942639
- Lead Sponsor
- Ludocare SAS
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 213
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard + JOE JOE Standard Maintenance Treatment plus JOE robot
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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...).
Trial Locations
- Locations (13)
CHU Amiens
🇫🇷Amiens, France
Cabinet de pneumologie pédiatrique La Fourane
🇫🇷Aix-en-Provence, France
APHP - Hôpital Ambroise Paré
🇫🇷Boulogne-Billancourt, France
CHRU Morvan
🇫🇷Brest, France
CHU Caen
🇫🇷Caen, France
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CHI Créteil
🇫🇷Créteil, France
Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, France
Groupe Hospitalier du Havre
🇫🇷Le Havre, France
Cabinet Medeo
🇫🇷Montluçon, France
CH Saint Joseph
🇫🇷Marseille, France
APHP - Hôpital Armand Trousseau
🇫🇷Paris, France
APHP - Hôpital Robert Debré
🇫🇷Paris, France