Asthma in ChildrenJoeCareNCT04942639
Evaluation of Efficacy and Tolerance of JOE on 4 to 11 Years Old Asthmatic Patients of GINA 2,3,4 and 5 Grades
A study testing JOE in people with Asthma in Children, run by Ludocare SAS at 13 sites in France.
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. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- JOE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 13 sitesFrance
- Study dates
- 18 Oct 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Cabinet de pneumologie pédiatrique La Fourane
Aix-en-Provence
CHU Amiens
Amiens
APHP - Hôpital Ambroise Paré
Boulogne-Billancourt
CHRU Morvan
Brest
CHU Caen
Caen
CHU Clermont-Ferrand
Clermont-Ferrand
CHI Créteil
Créteil
Groupe Hospitalier du Havre
Le Havre
CH Saint Joseph
Marseille
Cabinet Medeo
Montluçon
Hôpital Arnaud de Villeneuve
Montpellier
APHP - Hôpital Armand Trousseau
Paris
APHP - Hôpital Robert Debré
Paris
About this study
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.
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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- JOE
- Keywords
- Asthma, Children, Prevention, Severe Asthma Exacerbations
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JOEDevice
Audiovisual support by the robot when taking maintenance treatments at home.
| Study group | Role | What they receive |
|---|---|---|
| Standard + JOE | Experimental | Standard Maintenance Treatment plus JOE robot Receives: Device: JOE |
| Standard | No intervention | Standard maintenance Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
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.
Measured: 12 months
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...).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start18 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups: Standard Asthma Maintenance Treatment (SAMT) vs SAMT + Joe robot (a new DTX)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludocare SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinact
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942639
- Sponsor's protocol ID
- Asthma JoeCare
- Other IDs
- 2021-A00350-41
- Acronym
- JoeCare
- Status last verified
- Feb 2024
- First submitted
- 17 Jun 2021
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04942639
- Acronym / sponsor ID
- JoeCare / Asthma JoeCare
- Conditions
- Asthma in Children
- Keywords
- Asthma, Children, Prevention, Severe Asthma Exacerbations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Ludocare SASIndustry (pharma, biotech, devices)
- Collaborators
- Clinact
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups: Standard Asthma Maintenance Treatment (SAMT) vs SAMT + Joe robot (a new DTX)
| Arm | Type | Receives |
|---|---|---|
| Standard + JOE | Experimental | Device: JOEStandard Maintenance Treatment plus JOE robot |
| Standard | No intervention | –Standard maintenance Treatment |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JOEAudiovisual support by the robot when taking maintenance treatments at home. | Device | Standard + JOE |
Primary outcome
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.
3 secondary outcomes
Effectiveness of the maintenance treatment measured with c-ACT
Time frame: 12 months
Tolerance to the maintenance treatment evaluated by the number and type of adverse events
Time frame: 12 months
Global costs estimation evaluated by price
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Asthma in Children
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JOE in people with Asthma in Children, run by Ludocare SAS at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.