Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05260203
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2021-12-30
Brief Title:
MargheRITA Remote Intelligence for Therapeutic Adherence
Sponsor:
Advice Pharma Group srl
Organization:
Advice Pharma Group srl
Study Overview
Official Title:
Evaluation of Performance and Safety of APP RITA in Increasing the Therapeutic Adherence of Onco-Hematological Patients - a Prospective Monocentric Pre-Market Study With a Historical Group of Comparison
Status:
COMPLETED
Status Verified Date:
2023-02
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:
MargheRITA
Brief Summary:
It is essential to improve clinical efficiency and management of hematological and oncological patients treated on an outpatient basis The most promising operative way to achieve this result is the development of tele-oncology platforms that allow not only a telemedicine visit but also the patient support in the daily management of the disease and related disorders as well as treatments and their complications In this perspective the RITA communication platform should be able to support the patient the caregiver the physician and the general practitioner in the management of the disease and its treatments
Detailed Description:
Summary description of the investigational device
The RITA Remote Intelligence for Therapeutic Adherence application was designed on the doctors side as a support for the management of the onco-hematological patient and on the patients side as a first aid tool for the management of the most common problems as well as an efficient and non-invasive means of communication with the doctor The system also allows the caregiver and general practitioner to be included in the communication group
The added value of the app consists in improving the relationship between the patient and the doctor creating an effective communication channel increasing the safety the patient has when facing his difficult path reducing the number of visits to the facility and in general making those visits more efficient thus creating savings both in terms of time and resources RITA is also designed to communicate and receive information on the quality of life and side effects thus making the medical doctor aware of the progress of treatments in his patient population
Often occurs that the mild drugdisease related symptoms that the patient perceive during the treatment period are underestimated leading to a more severe symptomatology that could impair the patient adherence to treatment Thanks to the app RITA on the patients side it will be easier to notify their daily physical condition while on the physician side it will be easier to manage and solve the mild symptoms the patient could face during the treatment period improving the overall adherence to the treatment
The mobile app which can also be used on a conventional desktop or laptop aims to optimize the interaction between the onco-hematological patient and the referring physician The hospital doctor will have access to the website in order to manage all the functions through the appropriate dashboard
Intended purpose of the investigational device in the proposed clinical investigation
The application allows on the patient side to
record the relevant symptoms with a simple classification to be reported to the doctor at the next visit
record Quality of Life QoL data at pre-selected timepoints
inform the doctor about the necessary drug prescriptions
contact the doctor for advice for the same day
receive suggestions through both video and text specific to the most common problems that patients may face the advice can be specific in relation to the type of treatment carried out The consultation is personalized by the attending physician based on the clinical characteristics of the patient and the personalization takes place through the selection of a series of profiles created for the different types of patients eg fever in patients with mild moderate or severe impaired immune system etc
monitor relevant clinical parameters such as temperature heart rate blood pressure oxygen saturation respiratory rate glycemia
report information on the quality of life by filling in a specific questionnaire at defined timepoints
monitor the intake of specific drugs
manage contacts with the caregiver
While on the hospital doctor side the website allows to
have a quick and complete overview of the problems suffered by the patient in the period since the last visit thus making the visit faster and more productive
have information related to different and relevant clinical parameters measured and inserted from the patient including temperature heart rate blood pressure oxygen saturation respiratory rate glycemia the collection of this information will allow the doctor to have patients information necessary to carry out the appropriate clinical assessments on response to therapy stability andor relapse of the disease For example the temperature value can be communicated directly to the doctor to anticipate the prescription of the antibiotic
facilitate the home management of the most common clinical problems that the patient can face through videos and texts customizable by the doctor which explain how to deal with the most common symptoms in an initial phase
know in advance the drug prescriptions needed by the patient thus allowing to assign the prescription activity to the support staff
collect in a single container all daily communications of patients which are normally dispersed in a multiplicity of channels telephone calls faxes e-mails in order to be able to manage them conveniently
easily communicate with the caregiver
monitor patients QoL prospectively
Description of the specific medical procedures involved in the use of the investigational device
Possible features of the RITA app
possibility of reminder for drugs intake
possibility of creating a grading or threshold levels in case of symptoms such as fever eg temperature at 371C or 39C then a response is generated based on the grading eg go to the emergency room or take a drug
possibility for the doctor to select the advice to send to the patient
possibility for the doctor to select the type of pathology and the characteristics of the patient eg immunodepressed patient
possibility of integrating diets and ad hoc menus based on drugs administered
possibility of inserting tutorials eg how to send blood counts values
possibility of uploading contents both the doctor and the patient can send texts or multimedia contents
possibility of sending a warning about adherence to therapy both to the doctor and to the caregiver
Rationale for benefit-risk ratio
The major risk for onco-hematologic patients is the progression of their underlying disease and the consequent reduction in the quality of life which can be accelerated by a reduced adherence to the therapy Risks associated with participation in the clinical investigation are the same as the risks identified for the general use No additional risk is identified specifically related to the participation in the clinical investigation as the patient does not receive a lowered standard of care Moreover no special risks are reported due to the use of applications for adherence to treatment
Therefore the potential risks identified in association with the treatment administered with the App RITA are justified by the anticipated benefits resulting from the implementation of the standard of care aiming at improving the patients involvement in their own health management and intended increase of adherence to treatment
Primary Objective
The primary objective is the evaluation of patients compliance to treatment through the use of the app RITA thanks to more efficient management of the patients mild symptoms that could if not promptly treated lead to a more severe condition and sometimes to the treatment interruption
Secondary Objectives
Reduction of grade 3-4 treatment-related adverse events
Reduction in the number of visits to the emergency room for complications not requiring hospitalization careful monitoring of the patient both during follow-up visits and through the use of the RITA app allows for better control of complications reducing the patients need to access the emergency room
Reduction in the number of visits to the emergency room for severe complications requiring hospitalization careful monitoring of the patient both during follow-up visits and through the use of the RITA app allows for better control of complications reducing the patients need to access the emergency room
Reduction in the average number of days in hospital stay through careful monitoring of the patient both during follow-up visits and through the use of the RITA app it is possible to reduce the occurrence of severe complications that may require the patient to be hospitalized This objective evaluates the average number of days of hospitalization of the patient due to the onset of complications
Improvement in the quality of life perceived by the patient the use of tools in order to assess the quality of life for example questionnaires allows the medical doctor to check the patients perception of health and identify any limitations in daily life activities A constant survey allows to identify timely and more effective solutions aimed at improving the patients quality of life
User Experience the use of digital tools for example apps web systems etc to support the doctor-patient clinical health interactions allows continuous monitoring of the patient both with respect to any clinical complications and with regard to a worsening of the quality of life The indicator monitors the overall degree of patient satisfaction in relation to the use of the RITA app In this way it is possible to verify the real effectiveness of the app and intercept any elements of attention with respect to the features present
Primary Endpoint The primary endpoint is the evaluation of the therapeutic adherence measured as at least the 80 of the relative dose intensity defined as the ratio of delivered dose intensity to the prescribed referenced dose intensity expressed as a percentage during the study period The effectiveness of the RITA app use will be evaluated by comparing results on therapeutic adherence with a historical group of cancer patients
Secondary Endpoint
Secondary endpoints based on the comparisons between groups
Number of visits to the emergency room for complications not requiring hospitalization analysis will be performed on the population enrolled in the trial versus an historical control evaluating the recorded number of visits to the emergency room for minor complications not requiring hospitalization This information will be obtained by consulting the management control of the hospital or the emergency room system
Number of visits to the emergency room for severe complications requiring hospitalization analysis will be performed on the population enrolled in the trial versus an historical control evaluating the recorded number of visits to the emergency room for severe complications requiring hospitalization This information will be obtained by consulting the management control of the hospital or the emergency room system
Average number of days in hospital stay analysis will be performed on the population enrolled in the trial versus an historical control dividing the number of days in hospital stay for hematological patients by the number of hematological patients taken care of This information will be obtained by consulting the management control of the hospital
Number of AEminor complications not requiring assistance notified by the patient during the study period through the app RITA and directly during the clinical visit compared to the historical control group
To measure quantitatively the therapeutic adherence through the mean relative dose intensity defined as the ratio of delivered dose intensity to the prescribed referenced dose intensity expressed as a percentage during the study period
Secondary endpoints on the safety assessment of RITA APP
Occurrence of individual adverse events reported during the follow-up period during the user session and during intervals between one use session and the following
Occurrence of device adverse events during the user session
Medical Device CLASS IIA
Determination of Sample Size With a total of 112 patients 56 patients in the interventional arm and 56 in the patient-level historical group this investigation will have 80 power to detect a 20 improvement in treatment adherence ie in the intervention group 90 or more as compared to 70 Passardi et al 2022 with a one-sided type I error rate of 005 We set a goal of enrolling 124 patients to account for a drop-out rate of 10 Passardi et al 2022 with a consequent enrollment of 62 patients per arm
Statistical Analyses
In the primary analysis all the patients observed until the end of the study will be included
Patients in the historical group will be matched with patients in the prospective interventional study according to cancer diagnosis and type of anticancer treatment
The main characteristics of the patients will be reported using descriptive analyses by tabulating frequencies and percentages categorical variables and mean and median values standard deviations SD quartiles and extreme values continuous variables With reference to comparison between groups odds ratios OR and 95 confidence intervals CI will be calculated to evaluate the effectiveness of the RITA app using logistic regression models The statistical significance limit will be accepted as 5 and the results below this value P 05 will be considered statistically significant Comparisons within group ie in the interventional study group will be performed by using the paired t-test or the corresponding Wilcoxon signed-rank test a non-parametric test for paired samples after checking data were normally distributed based on the Shapiro-Wilk statistic Comparisons between groups ie interventional and historical for continuous data will be analysed using a two-sided Students t-test after checking data were normally distributed based on the Shapiro-Wilk statistic and a two-sided Wilcoxons rank-sum test otherwise For categorical data comparisons between groups will be performed by using the contingency table analysis with the Chi-square or Fishers exact test when appropriate Explorative analyses with descriptive purpose only will be performed in the subgroups of potential determinants of adherence of anticancer treatments including age gender educational status stage of disease comorbidities poly-pharmacy and complexity of oral anticancer regimensweeklydaily Adverse events occurring during the study follow-up will be tabulated
QUALITY ASSURANCE AND CONTROL
All participant data relating to the study will be recorded on eCRF The investigator is responsible for verifying that data entries are accurate and correct by electronically signing the eCRF
The investigator must maintain accurate documentation source data that supports the information entered in the eCRF
The investigator must permit study-related monitoring audits IRBIEC review and regulatory agency inspections and provide direct access to source data documents
Monitoring details describing strategy eg risk-based initiatives in operations and quality such as Risk Management and Mitigation Strategies and Analytical Risk-Based Monitoring methods responsibilities and requirements including handling of noncompliance issues and monitoring techniques central remote or on-site monitoring are provided in the monitoring plan
The sponsor or designee is responsible for the data management of this study including quality checking of the data
The sponsor assumes accountability for actions delegated to other individuals eg Contract Research Organizations
Study monitors will perform ongoing source data verification to confirm that data entered into the eCRF by authorised site personnel are accurate complete and verifiable from source documents that the safety and rights of participants are being protected and that the study is being conducted in accordance with the currently approved protocol and any other study agreements ICH GCP and all applicable regulatory requirements
Data Management System The CRFs in this trial are implemented electronically using a dedicated EDC system ICE Integrated Clinical Trial Environment Advice Pharma that fulfils the legal requirements for clinical trials The EDC system is activated for the user only after successfully passing a formal test procedure All data entered in the EDC are stored on a Linux server in a dedicated Oracle database
Monitoring The study will be monitored on a regular basis by the Sponsors adequately qualified and trained clinical Monitors throughout the study period to ensure the proper conduct of the clinical Investigation
The purposes of study monitoring are to verify that the rights and well-being of study subjects are protected that the reported study data are accurate complete and verifiable against the source documents and that the study is conducted in accordance with the current clinical investigation plan Good Clinical Practice guideline UNI EN ISO 14155 and applicable regulatory requirements
Audits and Inspections Upon request by the Sponsor on-site study audits may be conducted in order to ensure the study is in compliance with GCP applicable regulatory requirements and the clinical investigation plan The auditing activities may also be conducted after study completion
The RITA Remote Intelligence for Therapeutic Adherence application was designed on the doctors side as a support for the management of the onco-hematological patient and on the patients side as a first aid tool for the management of the most common problems as well as an efficient and non-invasive means of communication with the doctor The system also allows the caregiver and general practitioner to be included in the communication group
The added value of the app consists in improving the relationship between the patient and the doctor creating an effective communication channel increasing the safety the patient has when facing his difficult path reducing the number of visits to the facility and in general making those visits more efficient thus creating savings both in terms of time and resources RITA is also designed to communicate and receive information on the quality of life and side effects thus making the medical doctor aware of the progress of treatments in his patient population
Often occurs that the mild drugdisease related symptoms that the patient perceive during the treatment period are underestimated leading to a more severe symptomatology that could impair the patient adherence to treatment Thanks to the app RITA on the patients side it will be easier to notify their daily physical condition while on the physician side it will be easier to manage and solve the mild symptoms the patient could face during the treatment period improving the overall adherence to the treatment
The mobile app which can also be used on a conventional desktop or laptop aims to optimize the interaction between the onco-hematological patient and the referring physician The hospital doctor will have access to the website in order to manage all the functions through the appropriate dashboard
Intended purpose of the investigational device in the proposed clinical investigation
The application allows on the patient side to
record the relevant symptoms with a simple classification to be reported to the doctor at the next visit
record Quality of Life QoL data at pre-selected timepoints
inform the doctor about the necessary drug prescriptions
contact the doctor for advice for the same day
receive suggestions through both video and text specific to the most common problems that patients may face the advice can be specific in relation to the type of treatment carried out The consultation is personalized by the attending physician based on the clinical characteristics of the patient and the personalization takes place through the selection of a series of profiles created for the different types of patients eg fever in patients with mild moderate or severe impaired immune system etc
monitor relevant clinical parameters such as temperature heart rate blood pressure oxygen saturation respiratory rate glycemia
report information on the quality of life by filling in a specific questionnaire at defined timepoints
monitor the intake of specific drugs
manage contacts with the caregiver
While on the hospital doctor side the website allows to
have a quick and complete overview of the problems suffered by the patient in the period since the last visit thus making the visit faster and more productive
have information related to different and relevant clinical parameters measured and inserted from the patient including temperature heart rate blood pressure oxygen saturation respiratory rate glycemia the collection of this information will allow the doctor to have patients information necessary to carry out the appropriate clinical assessments on response to therapy stability andor relapse of the disease For example the temperature value can be communicated directly to the doctor to anticipate the prescription of the antibiotic
facilitate the home management of the most common clinical problems that the patient can face through videos and texts customizable by the doctor which explain how to deal with the most common symptoms in an initial phase
know in advance the drug prescriptions needed by the patient thus allowing to assign the prescription activity to the support staff
collect in a single container all daily communications of patients which are normally dispersed in a multiplicity of channels telephone calls faxes e-mails in order to be able to manage them conveniently
easily communicate with the caregiver
monitor patients QoL prospectively
Description of the specific medical procedures involved in the use of the investigational device
Possible features of the RITA app
possibility of reminder for drugs intake
possibility of creating a grading or threshold levels in case of symptoms such as fever eg temperature at 371C or 39C then a response is generated based on the grading eg go to the emergency room or take a drug
possibility for the doctor to select the advice to send to the patient
possibility for the doctor to select the type of pathology and the characteristics of the patient eg immunodepressed patient
possibility of integrating diets and ad hoc menus based on drugs administered
possibility of inserting tutorials eg how to send blood counts values
possibility of uploading contents both the doctor and the patient can send texts or multimedia contents
possibility of sending a warning about adherence to therapy both to the doctor and to the caregiver
Rationale for benefit-risk ratio
The major risk for onco-hematologic patients is the progression of their underlying disease and the consequent reduction in the quality of life which can be accelerated by a reduced adherence to the therapy Risks associated with participation in the clinical investigation are the same as the risks identified for the general use No additional risk is identified specifically related to the participation in the clinical investigation as the patient does not receive a lowered standard of care Moreover no special risks are reported due to the use of applications for adherence to treatment
Therefore the potential risks identified in association with the treatment administered with the App RITA are justified by the anticipated benefits resulting from the implementation of the standard of care aiming at improving the patients involvement in their own health management and intended increase of adherence to treatment
Primary Objective
The primary objective is the evaluation of patients compliance to treatment through the use of the app RITA thanks to more efficient management of the patients mild symptoms that could if not promptly treated lead to a more severe condition and sometimes to the treatment interruption
Secondary Objectives
Reduction of grade 3-4 treatment-related adverse events
Reduction in the number of visits to the emergency room for complications not requiring hospitalization careful monitoring of the patient both during follow-up visits and through the use of the RITA app allows for better control of complications reducing the patients need to access the emergency room
Reduction in the number of visits to the emergency room for severe complications requiring hospitalization careful monitoring of the patient both during follow-up visits and through the use of the RITA app allows for better control of complications reducing the patients need to access the emergency room
Reduction in the average number of days in hospital stay through careful monitoring of the patient both during follow-up visits and through the use of the RITA app it is possible to reduce the occurrence of severe complications that may require the patient to be hospitalized This objective evaluates the average number of days of hospitalization of the patient due to the onset of complications
Improvement in the quality of life perceived by the patient the use of tools in order to assess the quality of life for example questionnaires allows the medical doctor to check the patients perception of health and identify any limitations in daily life activities A constant survey allows to identify timely and more effective solutions aimed at improving the patients quality of life
User Experience the use of digital tools for example apps web systems etc to support the doctor-patient clinical health interactions allows continuous monitoring of the patient both with respect to any clinical complications and with regard to a worsening of the quality of life The indicator monitors the overall degree of patient satisfaction in relation to the use of the RITA app In this way it is possible to verify the real effectiveness of the app and intercept any elements of attention with respect to the features present
Primary Endpoint The primary endpoint is the evaluation of the therapeutic adherence measured as at least the 80 of the relative dose intensity defined as the ratio of delivered dose intensity to the prescribed referenced dose intensity expressed as a percentage during the study period The effectiveness of the RITA app use will be evaluated by comparing results on therapeutic adherence with a historical group of cancer patients
Secondary Endpoint
Secondary endpoints based on the comparisons between groups
Number of visits to the emergency room for complications not requiring hospitalization analysis will be performed on the population enrolled in the trial versus an historical control evaluating the recorded number of visits to the emergency room for minor complications not requiring hospitalization This information will be obtained by consulting the management control of the hospital or the emergency room system
Number of visits to the emergency room for severe complications requiring hospitalization analysis will be performed on the population enrolled in the trial versus an historical control evaluating the recorded number of visits to the emergency room for severe complications requiring hospitalization This information will be obtained by consulting the management control of the hospital or the emergency room system
Average number of days in hospital stay analysis will be performed on the population enrolled in the trial versus an historical control dividing the number of days in hospital stay for hematological patients by the number of hematological patients taken care of This information will be obtained by consulting the management control of the hospital
Number of AEminor complications not requiring assistance notified by the patient during the study period through the app RITA and directly during the clinical visit compared to the historical control group
To measure quantitatively the therapeutic adherence through the mean relative dose intensity defined as the ratio of delivered dose intensity to the prescribed referenced dose intensity expressed as a percentage during the study period
Secondary endpoints on the safety assessment of RITA APP
Occurrence of individual adverse events reported during the follow-up period during the user session and during intervals between one use session and the following
Occurrence of device adverse events during the user session
Medical Device CLASS IIA
Determination of Sample Size With a total of 112 patients 56 patients in the interventional arm and 56 in the patient-level historical group this investigation will have 80 power to detect a 20 improvement in treatment adherence ie in the intervention group 90 or more as compared to 70 Passardi et al 2022 with a one-sided type I error rate of 005 We set a goal of enrolling 124 patients to account for a drop-out rate of 10 Passardi et al 2022 with a consequent enrollment of 62 patients per arm
Statistical Analyses
In the primary analysis all the patients observed until the end of the study will be included
Patients in the historical group will be matched with patients in the prospective interventional study according to cancer diagnosis and type of anticancer treatment
The main characteristics of the patients will be reported using descriptive analyses by tabulating frequencies and percentages categorical variables and mean and median values standard deviations SD quartiles and extreme values continuous variables With reference to comparison between groups odds ratios OR and 95 confidence intervals CI will be calculated to evaluate the effectiveness of the RITA app using logistic regression models The statistical significance limit will be accepted as 5 and the results below this value P 05 will be considered statistically significant Comparisons within group ie in the interventional study group will be performed by using the paired t-test or the corresponding Wilcoxon signed-rank test a non-parametric test for paired samples after checking data were normally distributed based on the Shapiro-Wilk statistic Comparisons between groups ie interventional and historical for continuous data will be analysed using a two-sided Students t-test after checking data were normally distributed based on the Shapiro-Wilk statistic and a two-sided Wilcoxons rank-sum test otherwise For categorical data comparisons between groups will be performed by using the contingency table analysis with the Chi-square or Fishers exact test when appropriate Explorative analyses with descriptive purpose only will be performed in the subgroups of potential determinants of adherence of anticancer treatments including age gender educational status stage of disease comorbidities poly-pharmacy and complexity of oral anticancer regimensweeklydaily Adverse events occurring during the study follow-up will be tabulated
QUALITY ASSURANCE AND CONTROL
All participant data relating to the study will be recorded on eCRF The investigator is responsible for verifying that data entries are accurate and correct by electronically signing the eCRF
The investigator must maintain accurate documentation source data that supports the information entered in the eCRF
The investigator must permit study-related monitoring audits IRBIEC review and regulatory agency inspections and provide direct access to source data documents
Monitoring details describing strategy eg risk-based initiatives in operations and quality such as Risk Management and Mitigation Strategies and Analytical Risk-Based Monitoring methods responsibilities and requirements including handling of noncompliance issues and monitoring techniques central remote or on-site monitoring are provided in the monitoring plan
The sponsor or designee is responsible for the data management of this study including quality checking of the data
The sponsor assumes accountability for actions delegated to other individuals eg Contract Research Organizations
Study monitors will perform ongoing source data verification to confirm that data entered into the eCRF by authorised site personnel are accurate complete and verifiable from source documents that the safety and rights of participants are being protected and that the study is being conducted in accordance with the currently approved protocol and any other study agreements ICH GCP and all applicable regulatory requirements
Data Management System The CRFs in this trial are implemented electronically using a dedicated EDC system ICE Integrated Clinical Trial Environment Advice Pharma that fulfils the legal requirements for clinical trials The EDC system is activated for the user only after successfully passing a formal test procedure All data entered in the EDC are stored on a Linux server in a dedicated Oracle database
Monitoring The study will be monitored on a regular basis by the Sponsors adequately qualified and trained clinical Monitors throughout the study period to ensure the proper conduct of the clinical Investigation
The purposes of study monitoring are to verify that the rights and well-being of study subjects are protected that the reported study data are accurate complete and verifiable against the source documents and that the study is conducted in accordance with the current clinical investigation plan Good Clinical Practice guideline UNI EN ISO 14155 and applicable regulatory requirements
Audits and Inspections Upon request by the Sponsor on-site study audits may be conducted in order to ensure the study is in compliance with GCP applicable regulatory requirements and the clinical investigation plan The auditing activities may also be conducted after study completion
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