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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2024-12-31

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 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.

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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 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.

Conditions

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Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two parallel groups: Standard Asthma Maintenance Treatment (SAMT) vs SAMT + Joe robot (a new DTX)

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Data analysis performed on anonymous database.

Study Groups

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Standard + JOE

Standard Maintenance Treatment plus JOE robot

Group Type EXPERIMENTAL

JOE

Intervention Type DEVICE

Audiovisual support by the robot when taking maintenance treatments at home.

Standard

Standard maintenance Treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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JOE

Audiovisual support by the robot when taking maintenance treatments at home.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No