NCT04942639

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

June 17, 2021

Last Update Submit

February 27, 2024

Conditions

Asthma in Children

Keywords

Asthma, Children, Prevention, Severe Asthma Exacerbations

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Effectiveness of the maintenance treatment measured with c-ACT

    12 months

  • Tolerance to the maintenance treatment evaluated by the number and type of adverse events

    12 months

  • Global costs estimation evaluated by price

    12 months

Study Arms (2)

Standard + JOE

EXPERIMENTAL

Standard Maintenance Treatment plus JOE robot

Device: JOE

Standard

NO INTERVENTION

Standard maintenance Treatment

Interventions

JOEDEVICE

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

Standard + JOE

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Cabinet de pneumologie pédiatrique La Fourane

Aix-en-Provence, France

Location

CHU Amiens

Amiens, France

Location

APHP - Hôpital Ambroise Paré

Boulogne-Billancourt, France

Location

CHRU Morvan

Brest, France

Location

CHU Caen

Caen, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHI Créteil

Créteil, France

Location

Groupe Hospitalier du Havre

Le Havre, France

Location

CH Saint Joseph

Marseille, France

Location

Cabinet Medeo

Montluçon, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, France

Location

APHP - Hôpital Armand Trousseau

Paris, France

Location

APHP - Hôpital Robert Debré

Paris, France

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analysis performed on anonymous database.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two parallel groups: Standard Asthma Maintenance Treatment (SAMT) vs SAMT + Joe robot (a new DTX)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 28, 2021

Study Start

October 18, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(13)