Towards an Algorithmic Approach to Asthma Management: Collaborative Definition of Algorithm Objectives With Families (COPA)

February 28, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.).

Study Type

Observational

Enrollment (Actual)

307

Contacts and Locations

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

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Hôpital Ambroise Paré
      • Colombes, France, 92700
        • Hôpital Louis Mourier
      • Paris, France, 75019
        • Hopital Robert Debre
      • Paris, France, 75015
        • Hôpital Necker-Enfants Malades
      • Paris, France, 75012
        • Hôpital Trousseau-Allergologie pédiatrique
      • Paris, France, 75012
        • Hôpital Trousseau-Pneumologie pédiatrique

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

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Holders of parental authority
Holders of parental authority of patients with asthma described in group A
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.
Doctors
Doctors caring for patients with asthma described in group A
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean score attributed to each goal
Time Frame: Day 0
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of goals between respondents
Time Frame: Day 0
For each goal, the correlation of the scores attributed by children, their parents, and their doctors, will be calculated.
Day 0

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: David Drummond, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 18, 2022

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210819
  • 2021-A00041-40 (Other Identifier: ID RCB number)

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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