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

February 27, 2024 updated by: Ludocare SAS

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France
        • Cabinet de pneumologie pédiatrique La Fourane
      • Amiens, France
        • CHU Amiens
      • Boulogne-Billancourt, France
        • APHP - Hôpital Ambroise Paré
      • Brest, France
        • CHRU Morvan
      • Caen, France
        • CHU Caen
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand
      • Créteil, France
        • CHI Créteil
      • Le Havre, France
        • Groupe Hospitalier Du Havre
      • Marseille, France
        • CH Saint Joseph
      • Montluçon, France
        • Cabinet Medeo
      • Montpellier, France
        • Hopital Arnaud de Villeneuve
      • Paris, France
        • APHP - Hôpital Armand Trousseau
      • Paris, France
        • APHP - Hôpital Robert Debré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the mean number of severe asthma exacerbations per patient between the two treatment groups during the 12-month follow-up.
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of the maintenance treatment measured with c-ACT
Time Frame: 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.
12 months
Tolerance to the maintenance treatment evaluated by the number and type of adverse events
Time Frame: 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.
12 months
Global costs estimation evaluated by price
Time Frame: 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...).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludocare SAS

Collaborators

Clinact

Investigators

  • Principal Investigator: David Drummond, MD, APHP - Necker

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asthma JoeCare
  • 2021-A00350-41 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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