Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-29 @ 9:40 AM
Study NCT ID:
NCT05794568
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2023-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy of the OITcontrol Application.
Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Organization:
Study Overview
Official Title:
Multicenter, Open, Controlled, Randomized Study to Evaluate the Efficacy of the OITcontrol Application in Monitoring Patients in OIT With Food.
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: