Early Warning System for Allergic Rhinitis in the MASK-air® App
Randomised Controlled Trial on an Early Warning System for Allergic Rhinitis in the MASK-air® App
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In patients with allergic rhinitis, forecasting potential exacerbation of symptoms may allow patients to adopt the most adequate preventive measures. In this context, we are developing an early warning system combining atmospheric, pollen, patient symptoms and online activity data.
This early warning system will be incorporated in a mobile health app, and aims to provide patients with messages indicating whether exacerbations are expected in the subsequent five days.
To test the effectiveness of the early warning system in avoiding a worsening of patients' symptoms, undertaking a randomised controlled trial is warranted, particularly comparing personalised forecasting messages versus generic messages.
The clinical study will assess an early warning system, which will be developed through the CATALYSE project. This early warning system will be incorporated in MASK-air®, a mobile health app implemented in 19 European countries, and which allows for patients to register their daily allergic rhinitis symptoms(rhinitis, conjunctivitis and asthma) and medication. The early warning system will be based on: patients' symptom information (as registered in MASK-air®); and atmospheric and pollen forecasts provided by SILAM model and Copernicus systems (which are able to provide forecasts for six main allergic pollen types in Europe, and is able to assimilate new observations registered with an hourly time resolution).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bernardo Sousa-Pinto, PhD
- Phone Number: +351912362153
- Email: bernardo@med.up.pt
Study Locations
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Porto, Portugal
- Faculty of Medicine University of Porto
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Contact:
- Bernardo Sousa-Pinto, PhD
- Phone Number: +351912362153
- Email: bernardo@med.up.pt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients (≥18 years old) of both sexes with clinical diagnosis of allergic rhinitis according to ARIA associated with pollen allergy.
Exclusion Criteria:
- Illiterate patients
- Patients without smartphone
- Patients who are not able to complete a daily monitoring questionnaire on allergic rhinitis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Generic messages already delivered by MASK-air®
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Experimental: Early warning system personalised forecasting messages
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Early warning system personalised forecasting messages
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Combined symptom medication score values
Time Frame: From enrollment to the end of intervention at 2 weeks
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Daily symptom and medication data provided by patients allow the calculation of two validated daily combined symptom-medication scores from formulae previously published:
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From enrollment to the end of intervention at 2 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Universidade do Porto
- 101057131 (Other Grant/Funding Number: Horizon Europe research and innovation framework programme)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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