Proof of Concept of Remote Management of Chronic Inflammatory Airway Diseases for Patient Empowerment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Ospedaliero Universitaria di Sassari

About this trial

Chronic rhinosinusitis (CRS) is a multifactorial disease characterized by persistent symptomatic inflammation of the mucosa of the nose and paranasal sinuses, with (CRSwNP) or without (CRSsNP) the presence of nasal polyps. It affects 5 to 12% of the general population. CRS is often associated with asthma, which has a prevalence of 4% in the general population, reaching 30%-70% among patients with CRS. The current standard clinical evaluation of patients for both diseases has two main components: a subjective one (self-assessment provided by the patient), based mainly on the PROMs (Patient-Reported Outcome Measures) questionnaire, and an objective one (formulated by the clinician). Questionnaires present accuracy and response rate problems that have been investigated in the literature, finding that short questionnaires, incentives, personalization of questionnaires as well as repeat sending strategies or telephone reminders have a beneficial impact on the quantity and quality of responses. Today there are many new channels provided by technology. Among them, AI chatbots have been used in a variety of healthcare domains such as medical consultations, disease diagnosis, mental health support and, more recently, risk communications for the COVID-19 pandemic, and can offer a better way to collect questionnaires. At the same time, the recent technical solution of new non-invasive techniques for RFID radio frequency identification devices allows subjective reports to be accompanied with objective reports.

The PRECISION project aims to evaluate systems for home monitoring of chronic rhinosinusitis (CRS) and asthma, two highly prevalent chronic diseases. The frequent association between the two pathological conditions is a further argument in support of the rationality of a common approach.

As regards the collection of PROMs, three acquisition channels will be compared: i) AI Chatbots; ii) PhoneBot; iii) Mobile application. Data will be analyzed in relation to patient profiles to define the quality and quality of response.

Regarding objective evaluation, the project will investigate the efficiency of objective remote airflow measurements for both upper (CRS) and lower (asthma) airways using dedicated non-invasive systems based on RFID technology.

Eligibility criteria

Qualifiers

≥ 18 years

affected by chronic rhino sinusitis and/or asthma

not diagnosed with head and neck or lung cancer

no cardiovascular or metabolic uncontrolled diseases

Disqualifiers

< 18 years

affected by cancer or uncontrolled diseases

pregnant or breastfeeding women

uncompleted clinical history data

Trial design

Treatments tested in this trial

  • Radio Frequency IDentification (RFID) device

Treatment groups

136 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators

Azienda Ospedaliero Universitaria di Sassari

Lead sponsor

University of Rome Tor Vergata

Collaborator