Food AllergyALLERGIDOCNCT04887441
Allergology: Information, Data and Knowledge Organization
An observational study of Food Allergy and Peanut Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Digital technology is essential in the field of health, via connected objects, the medical Internet or even telemedicine; and the info-communication practices (ways of getting information and communicating) of the actors go through digital devices. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Food Allergy, Peanut Allergy
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthcare professional of the Allergy Unit of the University Hospital of Montpellier (France)
Who may be able to join
- Professionals from the Allergy Unit (doctors, interns, paramedics, study coordinators), in total around 20-30 people.
- Observations will be conducted during their team meetings and will not impact their workflow.
- Subjects publishing information on allergy on public web sites
Who cannot join
- Professional not willing to participate to the research.
- Users publishing information on private web sites or forums.
Trial locations and contacts
1 site in 1 country.
About this study
Digital technology is essential in the field of health, via connected objects, the medical Internet or even telemedicine; and the info-communication practices (ways of getting information and communicating) of the actors go through digital devices. In addition, at present, the mass of activity documents to be managed in healthcare establishments and an abundant supply of documentary resources in health, available on the Internet, lead to infobesity, information pollution, and work overload. These phenomena lead to an increase in the time spent searching for relevant information and even to the burnout of healthcare professionals. A contextualization of the information communication systems through which the practices of health professionals pass therefore seems necessary so that the tools for managing, extracting and organizing knowledge can support these actors in their work.
In the field of allergies, there are many players, and the information that is useful to them is abundant and heterogeneous. This study is based on the hypothesis that a knowledge organization model, developed from existing practices, could make it possible to obtain satisfactory results when searching for information, and be integrated into the daily practices of actors by linking up with other already existing systems and tools.
- Conditions
- Food Allergy, Peanut Allergy
- Keywords
- Food allergy, peanuts, Oral Immunotherapy, efficacy, safety
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the ontology model
measure (a) the efficiency of the model developed in the target technology (technology-focused evaluation), (b) the satisfaction of the professionals of the unit (user-focused evaluation) and (c) we will evaluate its formalization by an expert in knowledge organization systems (ontology-focused evaluation). The evaluations (a) and (b) will be made through the integration of the model into a future information communication device, and probably, into another existing device. The task will consist, for example, in the search for information and documents necessary for the information activities of professionals.
Measured: 24 months
Secondary outcomes (1)
Assessment and validation of the model
(a) At the end of the interrogation of a tool designed by professionals, we will calculate the recall rate, precision and F-measure. The efficiency of the model will be considered satisfactory, if the result obtained is equal or superior to other projects (b) The organizational model assessment will engage 10 professionals from the allergology unit. Professionals will assign (anonymously) the marks according to the level of satisfaction of the results of their request: 5 - Very satisfactory, 4 - Satisfactory, 3 - Fairly satisfactory, 2 - Unsatisfactory, 1 - Unsatisfactory. (c) The model will also be evaluated by a knowledge organization systems expert, selected from members of the International Society for Knowledge Organization.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Sep 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- LERASS-CERIC Université Paul Valéry Montpellier 3 Motpellier, Occitanie Region
- Responsible party
- Sponsor
- Investigators
- Davide CAIMMI, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887441
- Sponsor's protocol ID
- RECHMPL21_0253
- Acronym
- ALLERGIDOC
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergology: Information, Data and Knowledge Organization
- ClinicalTrials.gov ID
- NCT04887441
- Acronym / sponsor ID
- ALLERGIDOC / RECHMPL21_0253
- Conditions
- Food Allergy, Peanut Allergy
- Keywords
- Food allergy, peanuts, Oral Immunotherapy, efficacy, safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- LERASS-CERIC Université Paul Valéry Montpellier 3 Motpellier, Occitanie Region
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 14 May 2021 (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.
Digital technology is essential in the field of health, via connected objects, the medical Internet or even telemedicine; and the info-communication practices (ways of getting information and communicating) of the actors go through digital devices. In addition, at present, the mass of activity documents to be managed in healthcare establishments and an abundant supply of documentary resources in health, available on the Internet, lead to infobesity, information pollution, and work overload. These phenomena lead to an increase in the time spent searching for relevant information and even to the burnout of healthcare professionals. A contextualization of the information communication systems through which the practices of health professionals pass therefore seems necessary so that the tools for managing, extracting and organizing knowledge can support these actors in their work.
In the field of allergies, there are many players, and the information that is useful to them is abundant and heterogeneous. This study is based on the hypothesis that a knowledge organization model, developed from existing practices, could make it possible to obtain satisfactory results when searching for information, and be integrated into the daily practices of actors by linking up with other already existing systems and tools.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare professional of the Allergy Unit of the University Hospital of Montpellier (France)
Key inclusion criteria (3 listed)
- Professionals from the Allergy Unit (doctors, interns, paramedics, study coordinators), in total around 20-30 people.
- Observations will be conducted during their team meetings and will not impact their workflow.
- Subjects publishing information on allergy on public web sites
Key exclusion criteria (2 listed)
- Professional not willing to participate to the research.
- Users publishing information on private web sites or forums.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the ontology model
Time frame: 24 months
measure (a) the efficiency of the model developed in the target technology (technology-focused evaluation), (b) the satisfaction of the professionals of the unit (user-focused evaluation) and (c) we will evaluate its formalization by an expert in knowledge organization systems (ontology-focused evaluation). The evaluations (a) and (b) will be made through the integration of the model into a future information communication device, and probably, into another existing device. The task will consist, for example, in the search for information and documents necessary for the information activities of professionals.
1 secondary outcome
Assessment and validation of the model
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: Undecided. NC
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Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
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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. This study is not recruiting at the moment.
Davide CAIMMI study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy and Peanut Allergy, run by University Hospital, Montpellier at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the ontology model (time frame: 24 months). 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 14 May 2021.