Clinical trial NCT05794568: Evaluate the Efficacy of the OITcontrol Application.
Official title: Multicenter, Open, Controlled, Randomized Study to Evaluate the Efficacy of the OITcontrol Application in Monitoring Patients in OIT With Food.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy in Children
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 104
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main aim of this study is to evaluate the clinical efficacy of the OITcontrol application in patients undergoing OIT of eggs or milk used during the follow-up of this treatment.

Detailed description: 1. Evaluate the quality of life of patients with respect to their food allergy by analyzing the data from the FAQLQ-CF and/or SFAQoL-PF questionnaires.
2. Evaluate the perception of patients on the quality and safety of hospital care through the analysis of the adapted SERVQHOS questionnaire and the "Evolution of the perception of patients on the safety of health services".
3. Evaluate patient safety with OITcontrol based on:

   1. Number of reactions in the hospital,
   2. Number of reactions outside the hospital,
   3. Compliance with the information and recommendations by the patient:

   i. recording shots, ii. reaction log, iii. discordances between the medication used and prescribed after a reaction, iv. avoidance of cofactors.
4. Evaluate the consumption of health resources regarding the use, derived from the OIT of the following resources:

   1. Number of extraordinary visits to the allergy department,
   2. Number of phone calls for questions,
   3. Number of visits to the emergency department.

Eligibility criteria: Inclusion Criteria:

* The patient must be between 4 and 12 years old at the time of informed consent.
* Patients diagnosed with food allergy to eggs and/or milk (clinical history compatible with IgE-mediated reaction with egg or milk together with positive specific IgE against egg white or milk (\>0.35kU/L) and/or skin test by intraepidermal puncture equal to or similar to 3mm for egg white or milk); in case of egg allergy, patients may be allergic to raw or undercooked egg despite their tolerance to well-cooked egg.
* The patient, or their legally authorized representative, has given their consent to participate in the study.
* The patient, or his legally authorized representative, has accepted the OIT treatment after the explanation of its risks and benefits and the requirements for the maintenance phase.
* The patient must, in the opinion of the investigator, be able to meet all the requirements of the study.
* The patient, or their legally authorized representative, who assumes the OIT treatment at home, has a Smartphone with internet access via mobile data and/or Wi-Fi available at home.
* Reaction with the OIT allergen in the controlled oral provocation test (POC) included in the initial phase of treatment.

Exclusion Criteria:

* Present any of the OIT exclusion criteria:

  1. Allergy to cow's milk and/or eggs not mediated by IgE.
  2. Uncontrolled asthma. In the case of a patient with asthma, this must be controlled before the start of OIT.
  3. Severe atopic dermatitis.
  4. Previous diagnosis of eosinophilic esogaphitis.
  5. Inflammatory bowel disease.
  6. Mastocytosis.
  7. Immunocompromised patients.
  8. Disorders and/or treatments in which the use of adrenaline is contraindicated.
  9. Difficulty understanding the risks and benefits of the procedure, and social and family factors that may compromise long-term maintenance therapy. This includes conflicts between parents or legal representatives that may adversely affect treatment.
  10. Inability of parents or legal representative to follow instructions, identify reactions, or administer medication (especially auto-injectable adrenaline).
* Previous allergic reaction with the corresponding OIT food within the month prior to the initial visit.
* Treatment with omalizumab or any other immunomodulatory biologic drug within the three months prior to the initial visit.
* Pregnant women, or women of childbearing potential not using a safe means of contraception (abstinence is considered an acceptable method) during the entire study period.

Primary outcomes:
measure: The effectiveness of OITcontrol as an application to improve the quality of life.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Hospital Fundación Alcorcón
state: Madrid
city: Leganés
country: Spain
facility: Hospital Severo Ochoa
state: Madrid
city: Pamplona
country: Spain
facility: Universidad de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
References: