Early Warning System for Allergic Rhinitis in the MASK-air® App

NCT06768736 | Not Yet Recruiting

• 2 other identifiers: Universidade do Porto101057131
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective consists in the comparison of the combined symptom medication score values between (i) patients randomised to the early warning system personalised forecasting messages, and (ii) patients randomised to generic messages already delivered by MASK-air®. The combined symptom medication score has recently been developed in a data-driven way and validated (https://eaaci.org/images/CSMS.pdf); it assesses allergic rhinitis control taking into account both reported symptoms and medication use. As secondary objectives, visual analogue scales on allergic rhinitis symptoms (VAS global, nasal, eye, asthma), and medication use will also be separately compared.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Combined symptom medication score values

  Daily symptom and medication data provided by patients allow the calculation of two validated daily combined symptom-medication scores from formulae previously published: * the CSMS (combined symptom-medication score) * e-DASTHMA.

  From enrollment to the end of intervention at 2 weeks

Study Arms (2)

Generic messages already delivered by MASK-air®

NO INTERVENTION

Early warning system personalised forecasting messages

EXPERIMENTAL

Combination Product: Personalised early warning system

Interventions

Personalised early warning system COMBINATION_PRODUCT

Early warning system personalised forecasting messages

Early warning system personalised forecasting messages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult patients (≥18 years old) of both sexes with clinical diagnosis of allergic rhinitis according to ARIA associated with pollen allergy.

You may not qualify if:

• Illiterate patients
• Patients without smartphone
• Patients who are not able to complete a daily monitoring questionnaire on allergic rhinitis.

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar De São João, E.P.E.: collaborator

Study Sites (1)

Faculty of Medicine University of Porto

Porto, Portugal

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Bernardo Sousa-Pinto, PhD

CONTACT

+351912362153; bernardo@med.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: January 30, 2025
• Primary Completion: January 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: February 6, 2025

Record last verified: 2024-12

Locations

PT (1)