Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217419
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-11-07
Brief Title:
Proof of Concept of Remote Management of Chronic Inflammatory Airway Diseases for Patient Empowerment
Sponsor:
Azienda Ospedaliero Universitaria di Sassari
Organization:
Azienda Ospedaliero Universitaria di Sassari
Study Overview
Official Title:
Proof of Concept of Remote Management of Chronic Inflammatory Airway Diseases for Patient Empowerment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
PRECISION
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
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
Detailed Description:
The primary objective of the study is to create a Proof of Concept for the remote acquisition of subjectiveobjective data for patients with Asthma and CRS In the current standard clinical assessment of patients with chronic diseases such as asthma and CRS there are two main components one subjective provided by the patient and one objective provided by the doctor In particular subjective data are acquired via standardized PROMs such as SNOT-22 for CRS and ACT for asthma The collection of objective data is obtained through clinical evaluations such as endoscopic evaluation olfactometry radiological evaluation with the definition of Lund-Mackey score measurement of nasal flow usually through PNIF or rhinomanometry cytology blood tests in particular eosinophil count and IgE FeNO fractionated exhaled nitric oxide Both types of data are needed simultaneously for the correct treatment and follow-up of the disease and above all the quality of the measurements is crucial
The primary objective of the project is to quantify how much the patients experience in managing part of their illness remotely improves compared to a hospital visit
This will be quantitatively assessed through the administration of PREMs Patient-Reported Experience Measures questionnaires In particular in accordance with the state of the art the investigators will evaluate patient satisfaction based on two questionnaires
CSQ8 Client Satisfaction Questionnaire provides a quantitative evaluation of the treatment
PSSUQ Post-Study System Usability Questionnaire provides a quantitative assessment of the appropriateness of the technology used Finally the investigastors will evaluate patients satisfaction in being followed partly from home through an ad-hoc questionnaire
Secondary objective
Evaluation of the best channels for the administration of PROMs based on age group and cultural level
PROMs capture a persons perception of their health through questionnaires have a decidedly preponderant role in the clinical evaluation of patients with CRS and asthma according to the new classification systems and are the fulcrum of the subjective part eg SinoNasal Outcome Test SNOT Asthma Control Test ACT Chemosensory Complaint Score CCS Given the time-consuming nature of completing PROMs and the ease with which they can be performed remotely more and more PROMs are being delivered online eg with website forms The issue with such a modality in the real-world context is patient compliance over time as the low morbidity of controlled disease may be associated with decreased motivation Furthermore patients may need clarification on specific questions from healthcare professionals which contribute to the causes for which PROMs are still administered within many hospitals today
In this project three different channels will be evaluated
Social Network Chatbots Chatbots are natural language online human-computer dialogue systems The technology behind chatbots today is quite complex and spans the fields of natural language processing response generation and dialogue management Our goal is to evaluate the use of chatbots to increase engagement and implement explanations of PROMs The chatbot will also be used for medical remains which helps improve follow-up adherence By using existing social networks eg Whatsapp Telegram patients do not need specific training as they are already used to using instant messaging applications
Phonebot is a phone system that handles incoming and outgoing phone calls as well as an organizations internal communications The investigators will evaluate the effectiveness of using telephone calls to complete the survey required for PROMs The system evaluated uses synthetic voice to utter questions to patients and speechtone recognition to capture responses
Mobile App The availability of dedicated apps on smartphones and the possibilities offered by this technology push notifications personalized graphics and usability is another possible channel for administering PROMs The investigators will evaluate the effectiveness of this channel to acquire the responses of the PROMs
The channels will be provided to different patients with the aim of
Understand which channel provides better compliance such as persistence of data acquisition over time
Understand whether the channel shows a difference in the quality of data acquired through baseline data acquisition and clinical monitoring
Understanding which channel is most suitable for a specific patient profile analyzing the correlation of the activity with the age and education of the individual
Evaluation of the patient empowerment provided by the use of the channel Techniques for acquiring objective airflow data using non-invasive techniques will also be evaluated
Breath monitoring is an essential tool in the early diagnosis of respiratory and cardiovascular diseases In particular respiratory rate is crucial for monitoring the evolution of respiratory disorders such as Chronic Obstructive Pulmonary Disease COPD Chronic Rhinosinusitis CRS Asthma or the recent COVID-19 disease Breathing is typically monitored within a spirometry test that measures respiratory flows and consequently estimates respiratory volumes and rates However it can only be performed in a hospital with the supervision of a provider and requires the patient to breathe in a controlled manner while wearing nasal or oral probes Wearable and skin-friendly technologies may offer interesting alternatives to mitigate such discomfort In particular battery-free ultra-high frequency UHF radio frequency identification RFID devices could provide minimally invasive easy-to-use and low-cost diagnostic procedures
Therefore the project will consider techniques for the objective assessment of airflow and in particular
in asthma the forced expiratory volume in one second FEV1 and the peak expiratory flow PEF
in CRS the nasal peak inspiratory flow PNIF appears more reliable than anterior active rhinomanometry AAR and acoustic rhinometry AR i a commercially available portable spirometer will be used to measure PEF FEV remotely with an intuitive APP that assists patients in providing data receiving it and forwarding it to the hospital ii the same hardware can be used for measuring the PNIF through an adaptation of the software and connectable nasal masks available on the market As a result a portable dual-function device suitable for remote assessment of upper and lower airway function will be available by reusing and adapting available technology
The expected results of this specific objective are
definition of the patients breathing pattern using available tools and reliability for the early diagnosis of anomalous events
independent analysis of the performance of the nostrils and assessment of the reliability of obtaining an analogue of PNIF
evaluation of the reliability of the instruments in the definition of equivalent spirometric parameters
Data management will take place according to the rules defined by the Health Information Portability and Accountability Act HIPAA and in Europe by the General Data Protection Regulation GDPR
The remote approaches tested in this project will generate a huge amount of real data for analysis A specific data management plan will be developed to define in advance the methods for collecting managing and protecting clinical research data The plan will define specific data collection objectives data type and location data access roles and responsibilities allowing the research team a thorough understanding of the requirements
A key role will be played by the REDCap Research Electronic Data Capture platform which will be used to correctly collect and manage data This is a secure website application compliant with many standards such as FISMA and HIPAA developed to manage data for clinical research
During the experiments the data will be collected in 2 ways one will be standard with acquisition of subjective information PROM and objective information airflows clinical and endoscopic findings and subsequent data entry The other mode will benefit from specially created pipelines and will allow data to be acquired directly via MHT Mobile Health Technology and in the case of phonebots directly via the cloud and will therefore be totally automated This will drastically increase the amount of data potentially acquired through this second modality without logistical limitations and greater possibilities working with big data to build reliable predictive models for the diseases under investigation
The project will develop dedicated data pipelines to be automatically filled with PROMs and airflow data acquired via MHT into the Redcap database
The phonebot and chatbot will use cloud solutions such as Twilio Communication APIs for SMS Voice Video Authentication nd or Amazon Connect which in turn is based on Twilio These systems began as Private Branch Exchanges ie business telephone systems that manage incoming and outgoing calls and have evolved towards multi-channel communication systems They now integrate telephony SMS chatbots with different Instant Messaging channels real-time video streaming and email systems Furthermore they also integrate several related technologies such as artificial intelligence systems to manage conversation speech synthesis systems data flow and dialogue composition tools
The investigators will make use of such systems as convenient from different perspectives First due to their company policy Whatsapp forces their customers to use resellers like Twilio to access Whatsapp Business APIs that otherwise cannot be reached directly by us Secondly such cloud systems have the ability to scale to millions of users in minutes through the use of cloud computing which is very convenient as the project has the ambition to be easily replicated Finally solutions like Amazon Connect make use of cutting-edge Artificial Intelligence natural language processing solutions that are shared and then tested for effectiveness with the popular Amazon Alexa product Customized mobile applications will be developed to provide questionnaires to patients These applications will be released on Android and iOS platforms All these applications will be designed together with the project partners to derive the specifications of the finite state machine and clarify the usage flows
Statistical plan The planning of the three clinical studies was done considering the desired statistical power the short time for completion of the project only 2 years and the fact that the three clinical studies are de facto also Proof of concept for a very innovative approach with the ambition of changing the daily management of 2 very common chronic diseases and achieving a turning point towards real patient empowerment
For clinical trial 1 to achieve a confidence level of 95 and a confidence interval of 15 the required sample size was estimated at 40
As regards clinical study 2the investigators wanted to set up a study capable of detecting a 20 difference between the arms for which being a four-arm study 12 patients for each arm would be sufficient But also since it is a four-arm study some correction should be applied even a Bonferroni correction and if applied on the alpha value with six possible comparisons not only of the treatment groups with the control group but also between treatment groups the alpha value would go from 005 to approximately 0009 so the investigators considered it useful to increase each arm to 20 subjects total number of subjects 80
Finally for clinical trial 3 the investigators wanted to be able to detect 25 differences in airflow measurements between the standard in-office tests and the 2 home systems for which a sample size of 15 patients is required
To evaluate statistically significant differences for the primary endpoints the investigators will use
For trial 1 where the primary endpoint is patient satisfaction R-Square Chi-Square Pearson test and Fisher exact test to evaluate satisfaction of patients in the treatment group compared to the control group The alpha value will be set to 005
The analysis will be applied to the questionnaires PREMs mentioned previously in order to quantify the improvement in terms of patient experience treated using MHT spirometers and PROMs compared to the current scenario which only involves periodic in-person visits to the hospital
For trial 2 to evaluate the primary endpoint which is the completion rate of the questionnaires in the four arms the investigators will use ANOVA followed by t-tests to perform the 6 possible comparisons between the 6 groups For ANOVA an alpha value of 005 will be used while for single comparisons a Bonferroni adjustment will be applied bringing the alpha to 0009
The following figures of merit will be evaluated
completion rate how many questionnaires have been completed drop-off rate
quality of the answers also carried out through the analysis of meta-information eg gold questions and using the compilation of the questionnaires in the hospital as ground truth
best channel for the administration of PROMs with respect to the patients technological profile Phonebot Instant Messaging and dedicated Apps
patient empowerment through questionnaires For trial 3 the non-inferiority hypothesis will be tested by comparing remote measurements with standard ambulatory tests via paired t-tests Alpha will be set to 005
The secondary endpoints will be evaluated with the same software JMP from the SAS institute with appropriate statistical tools
Finally the aggregated data found will be the subject of scientific publications enriching the general know-how on the topic and therefore allowing secondary statistical uses of the data
The primary objective of the project is to quantify how much the patients experience in managing part of their illness remotely improves compared to a hospital visit
This will be quantitatively assessed through the administration of PREMs Patient-Reported Experience Measures questionnaires In particular in accordance with the state of the art the investigators will evaluate patient satisfaction based on two questionnaires
CSQ8 Client Satisfaction Questionnaire provides a quantitative evaluation of the treatment
PSSUQ Post-Study System Usability Questionnaire provides a quantitative assessment of the appropriateness of the technology used Finally the investigastors will evaluate patients satisfaction in being followed partly from home through an ad-hoc questionnaire
Secondary objective
Evaluation of the best channels for the administration of PROMs based on age group and cultural level
PROMs capture a persons perception of their health through questionnaires have a decidedly preponderant role in the clinical evaluation of patients with CRS and asthma according to the new classification systems and are the fulcrum of the subjective part eg SinoNasal Outcome Test SNOT Asthma Control Test ACT Chemosensory Complaint Score CCS Given the time-consuming nature of completing PROMs and the ease with which they can be performed remotely more and more PROMs are being delivered online eg with website forms The issue with such a modality in the real-world context is patient compliance over time as the low morbidity of controlled disease may be associated with decreased motivation Furthermore patients may need clarification on specific questions from healthcare professionals which contribute to the causes for which PROMs are still administered within many hospitals today
In this project three different channels will be evaluated
Social Network Chatbots Chatbots are natural language online human-computer dialogue systems The technology behind chatbots today is quite complex and spans the fields of natural language processing response generation and dialogue management Our goal is to evaluate the use of chatbots to increase engagement and implement explanations of PROMs The chatbot will also be used for medical remains which helps improve follow-up adherence By using existing social networks eg Whatsapp Telegram patients do not need specific training as they are already used to using instant messaging applications
Phonebot is a phone system that handles incoming and outgoing phone calls as well as an organizations internal communications The investigators will evaluate the effectiveness of using telephone calls to complete the survey required for PROMs The system evaluated uses synthetic voice to utter questions to patients and speechtone recognition to capture responses
Mobile App The availability of dedicated apps on smartphones and the possibilities offered by this technology push notifications personalized graphics and usability is another possible channel for administering PROMs The investigators will evaluate the effectiveness of this channel to acquire the responses of the PROMs
The channels will be provided to different patients with the aim of
Understand which channel provides better compliance such as persistence of data acquisition over time
Understand whether the channel shows a difference in the quality of data acquired through baseline data acquisition and clinical monitoring
Understanding which channel is most suitable for a specific patient profile analyzing the correlation of the activity with the age and education of the individual
Evaluation of the patient empowerment provided by the use of the channel Techniques for acquiring objective airflow data using non-invasive techniques will also be evaluated
Breath monitoring is an essential tool in the early diagnosis of respiratory and cardiovascular diseases In particular respiratory rate is crucial for monitoring the evolution of respiratory disorders such as Chronic Obstructive Pulmonary Disease COPD Chronic Rhinosinusitis CRS Asthma or the recent COVID-19 disease Breathing is typically monitored within a spirometry test that measures respiratory flows and consequently estimates respiratory volumes and rates However it can only be performed in a hospital with the supervision of a provider and requires the patient to breathe in a controlled manner while wearing nasal or oral probes Wearable and skin-friendly technologies may offer interesting alternatives to mitigate such discomfort In particular battery-free ultra-high frequency UHF radio frequency identification RFID devices could provide minimally invasive easy-to-use and low-cost diagnostic procedures
Therefore the project will consider techniques for the objective assessment of airflow and in particular
in asthma the forced expiratory volume in one second FEV1 and the peak expiratory flow PEF
in CRS the nasal peak inspiratory flow PNIF appears more reliable than anterior active rhinomanometry AAR and acoustic rhinometry AR i a commercially available portable spirometer will be used to measure PEF FEV remotely with an intuitive APP that assists patients in providing data receiving it and forwarding it to the hospital ii the same hardware can be used for measuring the PNIF through an adaptation of the software and connectable nasal masks available on the market As a result a portable dual-function device suitable for remote assessment of upper and lower airway function will be available by reusing and adapting available technology
The expected results of this specific objective are
definition of the patients breathing pattern using available tools and reliability for the early diagnosis of anomalous events
independent analysis of the performance of the nostrils and assessment of the reliability of obtaining an analogue of PNIF
evaluation of the reliability of the instruments in the definition of equivalent spirometric parameters
Data management will take place according to the rules defined by the Health Information Portability and Accountability Act HIPAA and in Europe by the General Data Protection Regulation GDPR
The remote approaches tested in this project will generate a huge amount of real data for analysis A specific data management plan will be developed to define in advance the methods for collecting managing and protecting clinical research data The plan will define specific data collection objectives data type and location data access roles and responsibilities allowing the research team a thorough understanding of the requirements
A key role will be played by the REDCap Research Electronic Data Capture platform which will be used to correctly collect and manage data This is a secure website application compliant with many standards such as FISMA and HIPAA developed to manage data for clinical research
During the experiments the data will be collected in 2 ways one will be standard with acquisition of subjective information PROM and objective information airflows clinical and endoscopic findings and subsequent data entry The other mode will benefit from specially created pipelines and will allow data to be acquired directly via MHT Mobile Health Technology and in the case of phonebots directly via the cloud and will therefore be totally automated This will drastically increase the amount of data potentially acquired through this second modality without logistical limitations and greater possibilities working with big data to build reliable predictive models for the diseases under investigation
The project will develop dedicated data pipelines to be automatically filled with PROMs and airflow data acquired via MHT into the Redcap database
The phonebot and chatbot will use cloud solutions such as Twilio Communication APIs for SMS Voice Video Authentication nd or Amazon Connect which in turn is based on Twilio These systems began as Private Branch Exchanges ie business telephone systems that manage incoming and outgoing calls and have evolved towards multi-channel communication systems They now integrate telephony SMS chatbots with different Instant Messaging channels real-time video streaming and email systems Furthermore they also integrate several related technologies such as artificial intelligence systems to manage conversation speech synthesis systems data flow and dialogue composition tools
The investigators will make use of such systems as convenient from different perspectives First due to their company policy Whatsapp forces their customers to use resellers like Twilio to access Whatsapp Business APIs that otherwise cannot be reached directly by us Secondly such cloud systems have the ability to scale to millions of users in minutes through the use of cloud computing which is very convenient as the project has the ambition to be easily replicated Finally solutions like Amazon Connect make use of cutting-edge Artificial Intelligence natural language processing solutions that are shared and then tested for effectiveness with the popular Amazon Alexa product Customized mobile applications will be developed to provide questionnaires to patients These applications will be released on Android and iOS platforms All these applications will be designed together with the project partners to derive the specifications of the finite state machine and clarify the usage flows
Statistical plan The planning of the three clinical studies was done considering the desired statistical power the short time for completion of the project only 2 years and the fact that the three clinical studies are de facto also Proof of concept for a very innovative approach with the ambition of changing the daily management of 2 very common chronic diseases and achieving a turning point towards real patient empowerment
For clinical trial 1 to achieve a confidence level of 95 and a confidence interval of 15 the required sample size was estimated at 40
As regards clinical study 2the investigators wanted to set up a study capable of detecting a 20 difference between the arms for which being a four-arm study 12 patients for each arm would be sufficient But also since it is a four-arm study some correction should be applied even a Bonferroni correction and if applied on the alpha value with six possible comparisons not only of the treatment groups with the control group but also between treatment groups the alpha value would go from 005 to approximately 0009 so the investigators considered it useful to increase each arm to 20 subjects total number of subjects 80
Finally for clinical trial 3 the investigators wanted to be able to detect 25 differences in airflow measurements between the standard in-office tests and the 2 home systems for which a sample size of 15 patients is required
To evaluate statistically significant differences for the primary endpoints the investigators will use
For trial 1 where the primary endpoint is patient satisfaction R-Square Chi-Square Pearson test and Fisher exact test to evaluate satisfaction of patients in the treatment group compared to the control group The alpha value will be set to 005
The analysis will be applied to the questionnaires PREMs mentioned previously in order to quantify the improvement in terms of patient experience treated using MHT spirometers and PROMs compared to the current scenario which only involves periodic in-person visits to the hospital
For trial 2 to evaluate the primary endpoint which is the completion rate of the questionnaires in the four arms the investigators will use ANOVA followed by t-tests to perform the 6 possible comparisons between the 6 groups For ANOVA an alpha value of 005 will be used while for single comparisons a Bonferroni adjustment will be applied bringing the alpha to 0009
The following figures of merit will be evaluated
completion rate how many questionnaires have been completed drop-off rate
quality of the answers also carried out through the analysis of meta-information eg gold questions and using the compilation of the questionnaires in the hospital as ground truth
best channel for the administration of PROMs with respect to the patients technological profile Phonebot Instant Messaging and dedicated Apps
patient empowerment through questionnaires For trial 3 the non-inferiority hypothesis will be tested by comparing remote measurements with standard ambulatory tests via paired t-tests Alpha will be set to 005
The secondary endpoints will be evaluated with the same software JMP from the SAS institute with appropriate statistical tools
Finally the aggregated data found will be the subject of scientific publications enriching the general know-how on the topic and therefore allowing secondary statistical uses of the data
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?:
None