Evaluation of Efficacy and Tolerance of JOE on 4 to 11 Years Old Asthmatic Patients of GINA 2,3,4 and 5 Grades

Asthma in Children Clinical Trial

— JoeCare  

Official title:

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 Asthma Maintenance Treatments and Provided by a Robot Named JOE.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04942639
• Other study ID #: Asthma JoeCare
• Secondary ID: 2021-A00350-41
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Ludocare SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 213
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Device:
• JOE
Audiovisual support by the robot when taking maintenance treatments at home.

Locations

Country	Name	City	State
France	Cabinet de pneumologie pédiatrique La Fourane	Aix-en-Provence
France	CHU Amiens	Amiens
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	Groupe Hospitalier du Havre	Le Havre
France	CH Saint Joseph	Marseille
France	Cabinet Medeo	Montluçon
France	Hôpital Arnaud de Villeneuve	Montpellier
France	APHP - Hôpital Armand Trousseau	Paris
France	APHP - Hôpital Robert Debré	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Ludocare SAS	Clinact

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the mean number of severe asthma 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	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
Secondary	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
Secondary	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