LOGOGRAM: Validation of Allergy Care Flowcharts in Primary Care: Experience From Occitanie (LOGOGRAM)

June 2, 2026 updated by: University Hospital, Montpellier

Validation Des Diagrammes de Flux d'Allergies en Soins Primaires : expérience de la région Occitanie

This study, aimed at validating decision trees developed through collaboration between general practitioners and allergists, seeks to provide French data to optimize care pathways for patients with allergic diseases from the primary care level and to reduce the delays and negative consequences associated with incorrect diagnoses. Most patients with allergic conditions are initially seen in primary care, often during exacerbations. Although allergies, in their many clinical forms, account for approximately 6-8% of primary care consultations, clinicians frequently receive little or no formal training in this field and may not be fully aware of the latest evidence, associated risks, or appropriate referral pathways. These gaps can significantly affect the quality of care and patients' quality of life, while also contributing to higher morbidity and mortality. In this context, the European Academy of Allergy and Clinical Immunology established a multidisciplinary task force to transform existing allergy guidelines into simple, practical, and accessible tools to facilitate diagnosis and management in primary care. The group developed five decision trees covering asthma, anaphylaxis, drug allergy, food allergy, rhinitis, and urticaria to support primary care physicians and other non-specialists in managing patients with symptoms suggestive of allergic or hypersensitivity reactions. The results of this project will be directly applicable to the daily clinical practice of general practitioners in France and could serve as a model for replication in other regions and countries, although adaptations may be required depending on national healthcare systems.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with suspected asthma, anaphylaxis, drug allergy, food allergy, rhinitis and urticaria.
  • Patients aged 1 year or older at inclusion, registered with a health insurance plan.
  • Patient or legal representative of the minor patient who agrees to participate in the research.

Exclusion Criteria:

  • Adults placed under guardianship or curatorship.
  • Patients already followed by an allergist and/or a specialist doctor for their allergies.
  • Patients who participate in a clinical research study relating to an antiallergic medication, immunosuppressant, immunomodulator in the year preceding their consultation visit with the GP.

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Interventional arm
Patients consulting in participating centers after implementation of decision trees designed to support physicians in the diagnosis and management of allergic diseases
Other: Implementation of an innovative tool based around AI-automated decision trees on an application
The application provides immediate access to the algorithms (decision trees). Investigators can access a dedicated interface and enter participant data, including the suspected diagnosis, symptoms, acute episode or history of allergic disease, and the medical decision made (diagnosis, therapeutic management, or referral to a specialist). Management options based on the five algorithms are then generated to support physicians in the diagnosis and management of allergic diseases.
No Intervention: Non-interventional arm
Patients consulting in participating centers before implementation of clinical decision trees intended to support physicians in the diagnosis and management of allergic diseases.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of referral to allergy specialists following primary care consultations for allergic diseases
Time Frame: through study completion, an average of 4 years
Comparison of the proportion of patients referred to an allergy specialist by general practitioners after consultations for suspected allergic diseases before and after implementation of the clinical decision trees in participating centers.
through study completion, an average of 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ease of use of the clinical decision trees
Time Frame: through study completion, an average of 4 years
The ease of use of the clinical decision trees will be assessed using an online questionnaire completed by general practitioners at the end of their participation. The questionnaire will evaluate ease of use (score from 1 to 5, from very difficult to very easy), precision of the clinical decision trees (score from 1 to 5, from inaccurate to very precise), confidence felt during their application in clinical practice (score from 1 to 5, from not confident at all to totally confident), average duration of use (minutes), and willingness to continue using the clinical decision trees in routine practice (yes/no).
through study completion, an average of 4 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL23_0327
  • 2025-A02183-46 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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