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Evaluate the Efficacy of the OITcontrol Application.

Primary Purpose

Food Allergy in Children

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
OITcontrol app monitoring
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Food Allergy in Children

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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: 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.

Sites / Locations

  • Hospital Fundación Alcorcón
  • Hospital Severo Ochoa
  • Universidad de Navarra
  • Hospital Gregorio Marañón
  • Hospital Clínico San Carlos
  • Hospital Infanta Leonor
  • Hospital Universitario Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

OITcontrol group

paperPRO group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 20, 2023
Last Updated
October 9, 2023
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT05794568
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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. 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". Evaluate patient safety with OITcontrol based on: Number of reactions in the hospital, Number of reactions outside the hospital, 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. Evaluate the consumption of health resources regarding the use, derived from the OIT of the following resources: Number of extraordinary visits to the allergy department, Number of phone calls for questions, Number of visits to the emergency department.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy in Children

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OITcontrol group
Arm Type
Active Comparator
Arm Title
paperPRO group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
OITcontrol app monitoring
Intervention Description
App to monitor OIT patients
Primary Outcome Measure Information:
Title
The effectiveness of OITcontrol as an application to improve the quality of life.
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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.
Facility Information:
Facility Name
Hospital Fundación Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Severo Ochoa
City
Leganés
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28010
Country
Spain
Facility Name
Hospital Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

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Evaluate the Efficacy of the OITcontrol Application.

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