Evaluate the Efficacy of the OITcontrol Application.

NCT05794568 | Completed

• 1 other identifier: OITcontrol_QL
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 7

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.

Conditions

Food Allergy in Children

Outcome Measures

Primary Outcomes (1)

• The effectiveness of OITcontrol as an application to improve the quality of life.

  Improve the quality of life of patients, as well as their perception of the quality and safety of hospital care, safety and the reduction of the consumption of health resources in patients under OITcontrol. * Baseline variables of the patient's clinical history in relation to their allergy to the allergen in the OIT, their base treatment and/or premedication, and the baseline sensitization parameters (skin test, total and specific IgE to the allergen of the OIT) obtained in the V0. The variables of the first day of treatment will be collected: threshold dose, last tolerated dose, and type of reaction presented. * The variables in the escalation visits will be taken in the space of time between two hospital visits. The data to be collected in a hospital visit correspond to the events that occurred during that hospital visit and in the home doses or extraordinary hospital visits of the previous week from the last ordinary hospi

  12 weeks

Study Arms (2)

OITcontrol group

ACTIVE COMPARATOR

Device: OITcontrol app monitoring

paperPRO group

NO INTERVENTION

Interventions

OITcontrol app monitoring DEVICE

App to monitor OIT patients

OITcontrol group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Allergy to cow's milk and/or eggs not mediated by IgE.
• Uncontrolled asthma. In the case of a patient with asthma, this must be controlled before the start of OIT.
• Severe atopic dermatitis.
• Previous diagnosis of eosinophilic esogaphitis.
• Inflammatory bowel disease.
• Mastocytosis.
• Immunocompromised patients.
• Disorders and/or treatments in which the use of adrenaline is contraindicated.
• 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.
• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (7)

Hospital Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Clínico San Carlos

Madrid, 28010, Spain

Location

Hospital Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: November 15, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 10, 2023

Record last verified: 2022-11

Locations

ES (7)