NCT05064579

Brief Summary

Using "big data" and artificial intelligence techniques, it becomes possible to envision algorithms for managing childhood asthma on a daily basis. In order to develop such tools, it is necessary to determine with asthma stakeholders (children, parents, doctors) the parameters that future algorithms should seek to maximize / minimize. The main objective of the study is to quantify the respective importance of each of the goals that children with asthma, parents, and their doctors seek to achieve when taking / supervising / prescribing a background therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 18, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 22, 2021

Last Update Submit

September 5, 2025

Conditions

Childhood Asthma

Keywords

Childhood asthmaAlgorithms for managing childhood asthmaBig dataArtificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Mean score attributed to each goal

    Children, their parents (or holders of parental authority), and their doctors will be asked to allocate 20 points to 7 goals they want to prevent with the asthma controller treatment, and another 20 points to 5 goals regarding their treatment modality (more discreet, easier to take, etc). The score for each goal will range from 0 (objective not important to the respondent) to 20 (objective of major importance to the respondent).

    Day 0

Secondary Outcomes (1)

  • Correlation of goals between respondents

    Day 0

Study Arms (3)

Patients with asthma

Children and adolescents aged 8 to 17 years old with a doctor's diagnosis of asthma and controller asthma treatment

Other: Questionnaires

Holders of parental authority

Holders of parental authority of patients with asthma described in group A

Other: Questionnaires

Doctors

Doctors caring for patients with asthma described in group A

Other: Questionnaires

Interventions

QuestionnairesOTHER

Questionnaire in two parts: one part on the objectives related to taking the treatment and the objectives related to the treatment modality and a second part on the general characteristics of each participant and the characteristics of the child's asthma.

DoctorsHolders of parental authorityPatients with asthma

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited in hospitals in the Ile-de-france region

You may qualify if:

  • Minor patients aged 8 years to 17 years and 11 months inclusive with a diagnosis of asthma made by a doctor and a basic treatment for asthma
  • Holders of parental authority for patients meeting the above criteria
  • Doctors caring for children with asthma
  • Information and non-opposition of holders of parental authority and minor patients to participate in the study

You may not qualify if:

  • Refusal to participate in the study
  • Difficulties in French writing and / or speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Hôpital Louis Mourier

Colombes, 92700, France

Location

Hôpital Trousseau-Allergologie pédiatrique

Paris, 75012, France

Location

Hôpital Trousseau-Pneumologie pédiatrique

Paris, 75012, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

Related Publications (1)

  • Masrour O, Personnic J, Amat F, Abou Taam R, Prevost B, Lezmi G, Gonsard A, Nathan N, Pirojoc A, Delacourt C, Wanin S, Drummond D. Objectives for algorithmic decision-making systems in childhood asthma: Perspectives of children, parents, and physicians. Digit Health. 2024 Feb 21;10:20552076241227285. doi: 10.1177/20552076241227285. eCollection 2024 Jan-Dec.

    PMID: 38389509BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David Drummond, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 1, 2021

Study Start

January 18, 2022

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)