NCT05794568

Evaluate the Efficacy of the OITcontrol Application.

Multicenter, Open, Controlled, Randomized Study to Evaluate the Efficacy of the OITcontrol Application in Monitoring Patients in OIT With Food.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Food Allergy in Children

Interventions

Type	Name	Description
DEVICE	OITcontrol app monitoring	App to monitor OIT patients

Timeline

• Start date: 2021-11-15
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2023-04-03
• Last updated: 2023-10-10

Locations

7 sites across 1 country: Spain