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

NCT06217419 | Not Yet Recruiting

• 1 other identifier: H73C22001600002
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps; Asthma

Keywords

Chatbot; Patient empowerment; Chronic rhinosinusitis; Airway diseases; Asthma; Patient-reported outcome measures (PROM)

Outcome Measures

Primary Outcomes (12)

• Trial 1: Measuring patient satisfaction through PREMs (CSQ-8) scores assessment.

  The evaluation will be done through standardized state-of-the-art PREMs ("Client Satisfaction Questionnaire", CSQ-8) scores and interviews. The unit of measure will be a pure number between 1 and 4 of the average CSQ-8 score. The satisfaction using (CSQ-8) between two groups will be measured.

  6 months

• Trial 1: Measuring rate of remotely completion of filling PROMs

  Rate of remote completion of PROMs (specifically SNOT22 for CRS and ACT for asthma) will be measured.

  6 months

• Trial 1: Measuring the difference of FEV1 (%) between remotely use of a portable spirometer and the clinical standard spirometer

  The difference in terms of FEV1 (%) values between the experimental group, which depends on remote self-patient values obtained by a portable spirometer, and the control group, which depends on a clinical standard spirometer, will be measured.

  6 months

• Trial 1: Evaluating the difference of PEF (L/sec) measurements between remotely use of a portable spirometer and the clinical standard spirometer

  The difference in terms of PEF (L/sec) values between the experimental group, which depends on remote self-patient values obtained by a portable spirometer, and the control group, which depends on a clinical standard spirometer, will be measured.

  6 months

• .Measuring the quality of the answers given to the Asthma Control Test (ACT) submitted through phonebot, instant messaging, and dedicated Apps.

  The Asthma Control Test (ACT) will be given to the participants as a patient-reported outcome measure (PROM), which is a questionnaire with 5 items assessing asthma symptoms (daytime and nocturnal), use of rescue medications, and the effect of asthma on daily functioning. The ACT survey will be provided using any of the phonebot, instant messaging, and dedicated Apps. For each technological channel (phonebot, instant messaging, and dedicated Apps), researchers will measure the quality of the answers using two methodologies taken from crowdsourcing, which are gold/repeated questions to measure self-consistency and meta-data analysis to spot random answers.

  6 months

• .Measuring the quality of the answers given to the Sino-Nasal Outcome Test-22 (SNOT22) submitted through phonebot, instant messaging, and dedicated Apps.

  The Sino-Nasal Outcome Test-22 (SNOT22) will be given to the participants as a patient-reported outcome measure (PROM) to find out how bad their CRS symptoms are, which include both classic nasal symptoms and extranasal symptoms like trouble sleeping, ear/facial pain, and mood changes, all of which have been linked to allergic rhinitis. The SNOT22 questionnaire will be provided using any of the phonebot, instant messaging, and dedicated Apps. For each technological channel (phonebot, instant messaging, and dedicated Apps), researchers will measure the quality of the answers using two methodologies taken from crowdsourcing, which are gold/repeated questions to measure self-consistency and meta-data analysis to spot random answers.

  6 months

• Trial 2: Measuring the quality of the answers of filling PROMs submitted through different channels.

  PROMs (SNOT22 and ACT) will be provided to the patients using different channels: Phonebot, Instant Messaging, and dedicated Apps. For each channel investigators will measure the quality of the answers using two methodologies taken from crowdsourcing which are gold/repeated questions to measure self-consistency, meta-data analysis to spot random answering.

  6 months

• Trial 2: Measuring best channel of filling PROMs submitted through different channels.

  PROMs (SNOT22 and ACT) will be provided to the patients using different channels: Phonebot, Instant Messaging, and dedicated Apps. For each channel investigators will measure the best channel according to the technological profile of the patient, measured by "Client Satisfaction Questionnaire" (CSQ-8) and interviews.

  6 months

• Trial 2: Measuring the drop-off rate of filling PROMs submitted through different channels.

  PROMs (SNOT22 and ACT) will be provided to the patients using different channels: Phonebot, Instant Messaging, and dedicated Apps. For each channel investigators will measure drop-off rate (ratio).

  6 months

• Trial 3: Evaluating the difference of PEF measurements between Mobile Health Devices with the standard of care.

  The difference in terms of values of PEF (l/sec) will be measured between two remote measurement tools, a portable spirometer, and an RFID-based solution, with the standardized ones used in ambulatory practice will be compared.

  Months 3 to 18

• Trial 3: Evaluating the difference of FEV1 measurements between Mobile Health Devices with the standard of care.

  The difference in terms of values of FEV1 (%) will be measured between two remote measurement tools, a portable spirometer, and an RFID-based solution, with the standardized ones used in ambulatory practice will be compared.

  Months 3 to 18

• Trial 3: Evaluating the difference of PNIF measurements between Mobile Health Devices with the standard of care.

  The difference in terms of values of PNIF (l/min) will be measured between two remote measurement tools, a portable spirometer, and an RFID-based solution, with the standardized ones used in ambulatory practice will be compared.

  Months 3 to 18

Study Arms (8)

Trial 1 - control group

NO INTERVENTION

On site visit every 3 months as for SoC

Trial 1 - PROMs + spirometer group

NO INTERVENTION

On site visit every 6 months. Monthly remote PROMs evaluation + portable spirometer measurement to remotely monitor the disease.

Trial 2 - control group

NO INTERVENTION

Monthly on site visit and paper PROMs.

Trial 2- Social Network Chatbot

NO INTERVENTION

PROM answered remotely weekly + monthly on site, first by themselves with the aid of Chatbot on the electronic forms and then under direct supervision of the clinicians.

Trial 2- Phonebot

NO INTERVENTION

PROM answered remotely weekly + monthly at hospital, first by themselves with the aid of Phonebot on the electronic forms and then under direct supervision of the clinicians.

Trial 2 - Mobile app

NO INTERVENTION

PROM answered remotely weekly + monthly at hospital, first by themselves with the aid of Mobile app on the electronic forms and then under direct supervision of the clinicians.

Trial 3 - asthma + CRSwNP Spirometer

NO INTERVENTION

Airflow monitoring recorded remotely with Spirometer every 2 weeks + on site visit every 2 month to compare wearable device with the standard one.

Trial 3 - asthma + CRSwNP RFID

EXPERIMENTAL

Airflow monitoring with RFID (daily) + on site visit every 2 months to compare wearable device with the standard one.

Device: Radio Frequency IDentification (RFID) device

Interventions

Radio Frequency IDentification (RFID) device DEVICE

RFID devices monitor breathing patterns by means of temperature measurements of the respiratory airflow. The temperature gradient of the air flow in and out of the airways can be correlated to the flow-based respiratory patterns. Accordingly, a temperature-based breath monitoring can be achieved by means of on-skin RFID sensors attached below the nose. Finally, a bilateral measurement of nostrils respiratory flow can provide more information since nasal cavities do not behave in the same way during a respiratory cycle. In this project we will evaluate the possibility to perform domestic breath flow analysis by exploiting thin, lightweight and battery-less sensing plasters directly attached under the nose. The system includes a proper external reader interrogating the face sensors that is capable to directly communicate with smartphone/pc/tablet/cloud environment.

Trial 3 - asthma + CRSwNP RFID

Eligibility Criteria

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

You may qualify if:

• ≥ 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
• if woman, not pregnant or breastfeeding
• able to understand and sign the informed consent and to perform procedures required by the protocol

You may not qualify if:

• \< 18 years
• affected by cancer or uncontrolled diseases
• pregnant or breastfeeding women
• uncompleted clinical history data
• unable to sign the informed consent or to perform procedures required by the protocol

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria di Sassari: lead
• University of Rome Tor Vergata: collaborator

Related Publications (20)

• Alzahrani YA, Becker EA. Asthma Control Assessment Tools. Respir Care. 2016 Jan;61(1):106-16. doi: 10.4187/respcare.04341. Epub 2015 Nov 10.

  PMID: 26556901 BACKGROUND

• Barr PJ, Scholl I, Bravo P, Faber MJ, Elwyn G, McAllister M. Assessment of patient empowerment--a systematic review of measures. PLoS One. 2015 May 13;10(5):e0126553. doi: 10.1371/journal.pone.0126553. eCollection 2015.

  PMID: 25970618 BACKGROUND

• Bousquet J, Clark TJ, Hurd S, Khaltaev N, Lenfant C, O'byrne P, Sheffer A. GINA guidelines on asthma and beyond. Allergy. 2007 Feb;62(2):102-12. doi: 10.1111/j.1398-9995.2006.01305.x.

  PMID: 17298416 BACKGROUND

• Brigham EP, West NE. Diagnosis of asthma: diagnostic testing. Int Forum Allergy Rhinol. 2015 Sep;5 Suppl 1:S27-30. doi: 10.1002/alr.21597.

  PMID: 26335833 BACKGROUND

• Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.

  PMID: 32077450 BACKGROUND

• Gallo S, Russo F, Mozzanica F, Preti A, Bandi F, Costantino C, Gera R, Ottaviani F, Castelnuovo P. Prognostic value of the Sinonasal Outcome Test 22 (SNOT-22) in chronic rhinosinusitis. Acta Otorhinolaryngol Ital. 2020 Apr;40(2):113-121. doi: 10.14639/0392-100X-N0364.

  PMID: 32469005 BACKGROUND

• Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.

  PMID: 31613151 BACKGROUND

• Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.

  PMID: 19793277 BACKGROUND

• Klimek L, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, Merk H, Olze H, Schlenter W, Stock P, Ring J, Wagenmann M, Wehrmann W, Mosges R, Pfaar O. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care: Position Paper of the German Society of Allergology (AeDA) and the German Society of Allergy and Clinical Immunology (DGAKI), ENT Section, in collaboration with the working group on Clinical Immunology, Allergology and Environmental Medicine of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNOKHC). Allergo J Int. 2017;26(1):16-24. doi: 10.1007/s40629-016-0006-7. Epub 2017 Jan 19.

  PMID: 28217433 BACKGROUND

• Knapp A, Harst L, Hager S, Schmitt J, Scheibe M. Use of Patient-Reported Outcome Measures and Patient-Reported Experience Measures Within Evaluation Studies of Telemedicine Applications: Systematic Review. J Med Internet Res. 2021 Nov 17;23(11):e30042. doi: 10.2196/30042.

  PMID: 34523604 BACKGROUND

• Lourijsen ES, Fokkens WJ, Reitsma S. Direct and indirect costs of adult patients with chronic rhinosinusitis with nasal polyps. Rhinology. 2020 Jun 1;58(3):213-217. doi: 10.4193/Rhin19.468.

  PMID: 32415826 BACKGROUND

• MacKinnon GE, Brittain EL. Mobile Health Technologies in Cardiopulmonary Disease. Chest. 2020 Mar;157(3):654-664. doi: 10.1016/j.chest.2019.10.015. Epub 2019 Oct 31.

  PMID: 31678305 BACKGROUND

• Nunes C, Pereira AM, Morais-Almeida M. Asthma costs and social impact. Asthma Res Pract. 2017 Jan 6;3:1. doi: 10.1186/s40733-016-0029-3. eCollection 2017.

  PMID: 28078100 BACKGROUND

• Ottaviano G, Lund VJ, Nardello E, Scarpa B, Frasson G, Staffieri A, Scadding K. Comparison between unilateral PNIF and rhinomanometry in healthy and obstructed noses. Rhinology. 2014 Mar;52(1):25-30. doi: 10.4193/Rhino13.037.

  PMID: 24618624 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Reddel HK, Bacharier LB, Bateman ED, Brightling CE, Brusselle GG, Buhl R, Cruz AA, Duijts L, Drazen JM, FitzGerald JM, Fleming LJ, Inoue H, Ko FW, Krishnan JA, Levy ML, Lin J, Mortimer K, Pitrez PM, Sheikh A, Yorgancioglu AA, Boulet LP. Global Initiative for Asthma Strategy 2021. Executive Summary and Rationale for Key Changes. Arch Bronconeumol. 2022 Jan;58(1):35-51. doi: 10.1016/j.arbres.2021.10.003. Epub 2021 Oct 28. English, Spanish.

  PMID: 35245179 BACKGROUND

• Rudmik L. Economics of Chronic Rhinosinusitis. Curr Allergy Asthma Rep. 2017 Apr;17(4):20. doi: 10.1007/s11882-017-0690-5.

  PMID: 28337570 BACKGROUND

• Seys SF, Bousquet J, Bachert C, Fokkens WJ, Agache I, Bernal-Sprekelsen M, Callebaut I, Cardel LO, Carrie S, Castelnuovo P, Cathcart R, Constantinidis J, Cools L, Cornet M, Clement G, de Sousa JC, Cox T, Doulaptsi M, Gevaert P, Hopkins C, Hox V, Hummel T, Hosemann W, Jacobs R, Jorissen M, Landis BN, Leunig A, Lund VJ, Mullol J, Onerci M, Palkonen S, Proano I, Prokopakis E, Ryan D, Riechelmann H, Saevels J, Segboer C, Speleman K, Steinsvik EA, Surda P, Tomazic PV, Vanderveken O, Van Gerven L, Van Zele T, Verhaeghe B, Vierstraete K, Vlaminck S, Wilkinson J, Williams S, Pugin B, Hellings PW. mySinusitisCoach: patient empowerment in chronic rhinosinusitis using mobile technology. Rhinology. 2018 Sep 1;56(3):209-215. doi: 10.4193/Rhin17.253.

  PMID: 29466477 BACKGROUND

• Sleurs K, Seys SF, Bousquet J, Fokkens WJ, Gorris S, Pugin B, Hellings PW. Mobile health tools for the management of chronic respiratory diseases. Allergy. 2019 Jul;74(7):1292-1306. doi: 10.1111/all.13720. Epub 2019 Apr 29.

  PMID: 30644567 BACKGROUND

• Vashishta R, Soler ZM, Nguyen SA, Schlosser RJ. A systematic review and meta-analysis of asthma outcomes following endoscopic sinus surgery for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2013 Oct;3(10):788-94. doi: 10.1002/alr.21182. Epub 2013 Jul 1.

  PMID: 23818462 BACKGROUND

MeSH Terms

Conditions

Asthma; Patient Participation

Interventions

Radio Frequency Identification Device

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Patient Identification Systems; Organization and Administration; Health Services Administration

Study Officials

• Francesco Bussu, MD

  Azienda Ospedaliero Universitaria di Sassari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Bussu, MD

CONTACT

00390792644509; fbussu@uniss.it

Claudia Crescio, PhD

CONTACT

00390792644552; claudia.crescio@aouss.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Trial 1 15 months Enrollment: month 6 to 9 Fup: 1 year 40 patients: 20 control group:standard fup each 3 months 20:standard on-site fup visit every 6 months + electronic questionnaires to report PROMs + FEV1 and/or PNIF to be performed by turning on the spirometer and connecting it to the app. Trial 2 1 year Enrollment: month 6 to 12 Fup: 6 months 80 patients: 40+asthma+CRSwNP 20+CRSwNP- asthma 20+asthma-CRSwNP PROM answered remotely weekly+monthly at hospital first by themselves with the aid of one of the 3 channels on the electronic forms and then under supervision of the clinicians. Pts in the standard channel will just fill the forms every month. Trial 3 6 months Enrollment: month 12 to 15 Fup:3 months Performed at home+periodic visits in the hospital 16 patients asthma+CRSwNP Randomized trial 2 arms, 8 pts per arm: airflow monitoring recorded remotely with Spirometer every 2 weeks or RFID daily + every 2 months at hospital (baseline, month 2) for both arms.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: January 22, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 22, 2024

Record last verified: 2024-01