AllergyLOGOGRAMNCT07631039
LOGOGRAM: Validation of Allergy Care Flowcharts in Primary Care: Experience From Occitanie
A study testing Implementation of an innovative tool based around AI-automated decision trees on an application in people with Allergy, run by University Hospital, Montpellier at 10 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Allergy
- What is being tested?
- Implementation of an innovative tool based around AI-automated decision trees on an application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 10 sitesFrance
- Study dates
- Sep 2026to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites
Msp Espace Sante Servian
Béziers, Occitanie, 34500
Jérôme CAMPAGNAC, MD, +33467764005, jerome.campagnac@umontpellier.fr
MSP Universitaire Avicenne
Cabestany, Occitanie, 66330
Agnes OUDE ENGBERINK, MD, +33426030690, agnes.oude-engberink@umontpellier.fr
Msp Montpellier -Cevenne
Montpellier, Occitanie, 34080
Karolina GRIFFITHS, MD, +33783452124, karolina.griffiths@umontpellier.fr
Msp Narbo Ouest
Narbonne, Occitanie, 11100
Jean-Baptiste TOSTAIN, MD, +33468938819, jean-baptiste.tostain@umontpellier.fr
Msp Charles Gide
Nîmes, Occitanie, 30000
Alexis VANDEVENTER, MD, +33448065260, alexis.vandeventer@umontpellier.fr
Msp Beau Art
Perpignan, Occitanie, 66000
Sylvain PAVAGEAU, MD, +33468516033, sylvain.pavageau@umontpellier.fr
MSP Calypso
Roujan, Occitanie, 34320
Bénédicte TEISSERENC, MD, + 33686169 218, benedicte.teisserenc@umontpellier.fr
Département Universitaire de Médecine Générale MSPU CHU Montpellier
Saint-Georges-dOrques, Occitanie, 34680
Béatrice LOGNOS, MD, +33603451697, beatrice.lognos@umontpellier.fr
Msp Sud Minevoir
Saint-Marcel-sur-Aude, Occitanie, 11120
Melissa MORENO, MD, +33411669785, drmelissamoreno@outlook.fr!
MSP Pézenas-Tourbes
Tourbes, Occitanie, 34120
Laure FERRIERE, MD, +33467988160, laureferrieres@gmail.com
About this study
Official title: 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.
- Conditions
- Allergy
- Being tested
- Implementation of an innovative tool based around AI-automated decision trees on an application
- Keywords
- diagnosis, general practitioner, flowchart, care pathway
- Medical subject headings
- Hypersensitivity, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of an innovative tool based around AI-automated decision trees on an applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Patients consulting in participating centers after implementation of decision trees designed to support physicians in the diagnosis and management of allergic diseases Receives: Other: Implementation of an innovative tool based around AI-automated decision trees on an application |
| Non-interventional arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Rate of referral to allergy specialists following primary care consultations for allergic diseases
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.
Measured: through study completion, an average of 4 years
Secondary outcomes (1)
Ease of use of the clinical decision trees
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).
Measured: through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge cluster randomized study design. Participants are enrolled in 10 investigation centers. Centers (clusters), rather than individual participants, are randomized according to a stepped-wedge cluster design, with sequential implementation of the intervention at predefined time periods until all centers receive the intervention.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631039
- Sponsor's protocol ID
- RECHMPL23_0327
- Other IDs
- 2025-A02183-46
- Acronym
- LOGOGRAM
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Des Diagrammes de Flux d'Allergies en Soins Primaires : expérience de la région Occitanie
- ClinicalTrials.gov ID
- NCT07631039
- Acronym / sponsor ID
- LOGOGRAM / RECHMPL23_0327
- Conditions
- Allergy
- Keywords
- diagnosis, general practitioner, flowchart, care pathway
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized study design. Participants are enrolled in 10 investigation centers. Centers (clusters), rather than individual participants, are randomized according to a stepped-wedge cluster design, with sequential implementation of the intervention at predefined time periods until all centers receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Other: Implementation of an innovative tool based around AI-automated decision trees on an applicationPatients consulting in participating centers after implementation of decision trees designed to support physicians in the diagnosis and management of allergic diseases |
| Non-interventional arm | No intervention | –Patients consulting in participating centers before implementation of clinical decision trees intended to support physicians in the diagnosis and management of allergic diseases. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of an innovative tool based around AI-automated decision trees on an applicationThe 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. | Other | Interventional arm |
Primary outcome
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.
1 secondary outcome
Ease of use of the clinical decision trees
Time frame: through study completion, an average of 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of an innovative tool based around AI-automated decision trees on an application in people with Allergy, run by University Hospital, Montpellier at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascal DEMOLY, Pr (+33467336107, pascal.demoly@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of referral to allergy specialists following primary care consultations for allergic diseases (time frame: through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.