Loading clinical trials...
Loading clinical trials...
Multicenter, Open, Controlled, Randomized Study to Evaluate the Efficacy of the OITcontrol Application in Monitoring Patients in OIT With Food.
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.
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.
Age
4 - 12 years
Sex
ALL
Healthy Volunteers
Yes
Hospital Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Severo Ochoa
Leganés, Madrid, Spain
Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Infanta Leonor
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Start Date
November 15, 2021
Primary Completion Date
September 30, 2023
Completion Date
September 30, 2023
Last Updated
October 10, 2023
104
ACTUAL participants
OITcontrol app monitoring
DEVICE
Lead Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
NCT06034678
NCT06618963
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04376242