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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05794568
Other study ID # OITcontrol_QL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2021
Est. completion date September 30, 2023

Study information

Verified date November 2022
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OITcontrol app monitoring
App to monitor OIT patients

Locations

Country Name City State
Spain Hospital Fundación Alcorcón Alcorcón Madrid
Spain Hospital Severo Ochoa Leganés Madrid
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Gregorio Marañón Madrid
Spain Hospital Infanta Leonor Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Universidad de Navarra Pamplona Navarra

Sponsors (1)

Lead Sponsor Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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