## Protocol Section
### Identification Module
**NCT ID:** NCT05064579

**Acronym:** COPA

**Brief Title:** Towards an Algorithmic Approach to Asthma Management: Collaborative Definition of Algorithm Objectives With Families

**Official Title:** Towards an Algorithmic Approach to Asthma Management: Collaborative Definition of Algorithm Objectives With Families

#### Organization Study ID Info
**ID:** APHP210819
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
#### Secondary ID Infos
**Domain:** ID RCB number
**ID:** 2021-A00041-40
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2023-01-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-01-30

**Type:** ACTUAL

#### Start Date
**Date:** 2022-01-18

**Type:** ACTUAL

**Status Verified Date:** 2023-03

#### Study First Post Date
**Date:** 2021-10-01
**Type:** ACTUAL
**Study First Submit Date:** 2021-09-22
**Study First Submit QC Date:** 2021-09-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assistance Publique - Hôpitaux de Paris

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.).

### Conditions Module

**Conditions:**

- Childhood Asthma

**Keywords:**

- Childhood asthma

- Algorithms for managing childhood asthma

- Big data

- Artificial intelligence

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 307

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Questionnaires

**Label:** Patients with asthma

#### Arm Group 2

**Description:** Holders of parental authority of patients with asthma described in group A

**Intervention Names:**

- Other: Questionnaires

**Label:** Holders of parental authority

#### Arm Group 3

**Description:** Doctors caring for patients with asthma described in group A

**Intervention Names:**

- Other: Questionnaires

**Label:** Doctors

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Doctors

- Holders of parental authority

- Patients with asthma

**Description:** 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.

**Name:** Questionnaires

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Mean score attributed to each goal

**Time Frame:** Day 0

#### Secondary Outcomes

**Description:** For each goal, the correlation of the scores attributed by children, their parents, and their doctors, will be calculated.

**Measure:** Correlation of goals between respondents

**Time Frame:** Day 0

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 8 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Participants will be recruited in hospitals in the Ile-de-france region

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boulogne-Billancourt

**Country:** France

**Facility:** Hôpital Ambroise Paré

**Zip:** 92100

**Location 2:**

**City:** Colombes

**Country:** France

**Facility:** Hôpital Louis Mourier

**Zip:** 92700

**Location 3:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Trousseau-Allergologie pédiatrique

**Zip:** 75012

**Location 4:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Trousseau-Pneumologie pédiatrique

**Zip:** 75012

**Location 5:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Necker-Enfants Malades

**Zip:** 75015

**Location 6:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Robert Debré

**Zip:** 75019

#### Overall Officials

**Official 1:**

**Affiliation:** Assistance Publique - Hôpitaux de Paris

**Name:** David Drummond, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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:** 38389509

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Misc Info Module

- Version Holder: 2024-05-24
