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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05064579
Other study ID # APHP210819
Secondary ID 2021-A00041-40
Status Completed
Phase
First received
Last updated
Start date January 18, 2022
Est. completion date January 30, 2023

Study information

Verified date March 2023
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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. To do this, parents and children fill out a paper questionnaire, which is completed by their doctor, when they come to the hospital for consultation, hospitalization, or to perform lung function tests. Concerning children and parents, these questionnaires include a part aimed at prioritizing each person's objectives and a second part collecting general information regarding their characteristics (age, sex, asthma history, etc.).


Recruitment information / eligibility

Status Completed
Enrollment 307
Est. completion date January 30, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Refusal to participate in the study - Difficulties in French writing and / or speaking

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaires
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.

Locations

Country Name City State
France Hôpital Ambroise Paré Boulogne-Billancourt
France Hôpital Louis Mourier Colombes
France Hôpital Necker-Enfants Malades Paris
France Hôpital Robert Debré Paris
France Hôpital Trousseau-Allergologie pédiatrique Paris
France Hôpital Trousseau-Pneumologie pédiatrique Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. D — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Correlation of goals between respondents For each goal, the correlation of the scores attributed by children, their parents, and their doctors, will be calculated. Day 0
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