2. Materials and Methods
The TeNDER system is an integrated care system for people with chronic diseases such as AD, PD and CVD developed in the framework of an H2020 project. It consists of a web app (for professionals), mobile app (for patients and caregivers) and a series of sensors and devices (wristband, binary sensors, depth cameras, among others) thanks to which different symptoms are monitored.
Thanks to the TeNDER system, patients and their carers can on the one hand monitor their state of health and receive feedback on the rehabilitation exercises carried out at the therapy centre. The system also has a recommendation system, which, thanks to the information obtained from the sensors and the interaction with other functionalities of the mobile app, sends users advice, warnings, and recommendations for areas of their daily life such as physical activity, social aspects, nutrition or sleep. Likewise, professionals obtain objective data on the state of health of patients that they can visualise thanks to the web app, enabling closer monitoring. Professionals can contact patients and caregivers through the communication tools of the TeNDER system, for example by including appointments or reminders in the calendar of the patient/caregiver app.
2.1. Codesign process
To ensure the acceptability and usability of the TeNDER system from the beginning of its development, a careful co-design process has been carried out to ensure a person-centred approach. Process has been present in all phases of system development and has involved a constant evolution of gathering direct feedback from end-users and implementing their needs through user needs and requirements.
The co-design process started in M1 of the project and, as a first step, a careful literature search was conducted to define the state of the art, experts in the care and treatment of chronic pathology sufferers (PD, AD and CVD) were consulted and a discussion was held among consortium members representing end-users, including hospitals, regional health systems and patient associations. The main conclusions were:
First, it is imperative to personalise the TeNDER system according to the three types of users – patients, caregivers, and professionals – all of whom have different needs in their reliance on the system. One important aspect of this digital health system for patients is its ability to empower them in their knowledge and management of their own health. The application provides assistance in adhering to therapies and treatment as well as information that aids in the decision-making processes related to the patients’ health. Caregivers, on the other hand, benefit from the system in that they are better able to understand the health status of their loved ones, interact with professionals, and receive warning notifications when patients are in concerning or dangerous situations. These different purposes should be considered in the personalisation of the system, as should the varying technological preferences of end-users. Patients and caregivers have reported that a mobile or tablet application is more accessible. Meanwhile, professionals would prefer not to rely on a mobile application, as the smaller screens make it more difficult to easily see large quantities of patient lists and data at once. Consequently, a web version of the TeNDER system was developed specifically for professionals. Another important factor in customising the system to each user is specific characteristics that would influence the user experience. These include age, gender, educational level, technological affinity, country of origin, main disease (if a patient), and associated comorbidities. It is also important to consider aspects like marital status, lifestyle habits such as smoking, alcohol consumption, physical activity, quality of sleep, rural or urban living environment, and whether living alone or with others.
The co-design process continued with a survey in 4 countries (Spain, Italy, Slovenia, and Germany) for each of the end-user types (patients, carers and professionals) with the participation of 100 patients, 100 carers and 50 health and social care professionals. In addition, 15 face-to-face interviews were conducted with patients, 15 with carers and 15 with professionals.
With the information gathered in the first phases of the co-design process, the first version of the TeNDER System was developed. This was followed by two waves of testing, in which data was collected on the perceptions of all users in terms of usability, usefulness, acceptability, ease of use, as well as all kinds of qualitative comments with proposals for improvement and modification of the system.
The first wave of testing took place between November 2020 and April 2021 and involved 124 patients, 73 carers and 53 professionals. The second wave of testing took place between November 2021 and June 2022 and involved 195 patients, 104 carers and 38 professionals. The co-design process at this stage has been a cyclical procedure of collecting feedback and improving the system leading to a final version of the system.
2.2. User needs and requirements
To better understand the needs of end-users, various scenarios involving the implementation of the TeNDER system, the wearables used, and the type of data collected, were drafted, and shown to patients, caregivers, and professionals. These groups of end-users provided evaluations of the usefulness of the various devices and their functionalities in each scenario. Based on this feedback, WP2 (Work Package 2) determined the main functional requirements of the system in several different settings, including the private home, hospital, day-care, and rehabilitation room. These functional requirements include medical examination schedule, adherence to drug treatment, health state, emotional state detection, nocturnal activities, global localization, room-level localization, and safety and wellbeing. Additionally, a table of recommendations from end-users in the first phase of co-design was compiled to guide further improvements to the system. Most patients with AD, PD, and CVD are of the older generations, and only 18% of TeNDER patients are familiar with technology. Therefore, it is imperative that the system is simple and easy to use. This simplicity can be achieved through easier-to-read fonts and screen layouts with minimal components.
Another frequent recommendation from end-users was customisation. Different functionalities can be more helpful to different users, and so it is imperative that, at the very least, the system has distinct offerings for patients, caregivers, and professionals respectively. For example, it is necessary for professionals to have access to patient lists and data, while caregivers and patients themselves should not have this feature available on their screens. In addition, the system should be able to adapt alongside the progression of the disease, due to the possibility that patients’ needs will change as this occurs. Another aspect of the system for which customisation was recommended was the frequency of reports. Both patients and caregivers agreed that the structure of alerts and reminders should be altered. Caregivers felt they should be given priority notification on urgent alerts and receive feedback if a patient has not completed an activity they were reminded to complete. Patients also expressed the desire for more vital reminders to be distinguished from less urgent ones. Finally, all three user groups recommended that the system feature real time activity tracking, more accurate functions to enable better understanding of the reports, and a multimodal tool for the alerts that would make the system more accessible. Ultimately, the two main goals devised from this feedback is a) customisation and b) ease of use.
The main findings of the co-design process are set out in the following
Table 1.
2.3. TeNDER integrated components
To meet the needs and requirements gathered throughout the co-design process, the TeNDER system has articulated 5 technical components that are the basis for all interactions with the system:
An Electronic Health Record (EHR) as TeNDER system backend, that was developed using HL7 standards. HL7 is a widely used communication protocol technology that allows for the exchange of clinical data, allowing internal researchers to manage data from patients, and observations from the sensorial devices. It helped providing easy access to patient information for healthcare providers, while also reducing errors and improving patient safety.
The Multimodal Fusion (MMF) module helps to provide a more complete view of patient data, enabling the system to provide more individualised recommendations to patients and helping both professionals and caregivers to better understand the patient's health status. In addition, the MMF module tracks the emotional state and irregular behaviour of patients, sending important notifications and recommendations to both caregivers and patients.
The virtual assistant module consists of two sub-modules: the reminder sub-module and the chat sub-module with the aim of facilitating patient interaction with the system. It incorporates voice commands for the components installed in users' homes so that interaction with the system is done via voice command. Examples of events detected through Speech Analytics include the client asking what day or time it is or requesting that a notification be sent to their caregiver.
User profiling is based on a combination of data fusion of sensory ecosystem data and patient information to discover connections between the patient's health status and patterns of daily behaviour. User profiling aims to group patients according to common characteristics, which helps to personalise recommendations for each patient group. To perform user profiling, this component uses personal information such as gender, age, country and language, diagnoses among the three main TeNDER diseases, comorbidities and multimodal fusion data.
Finally, the Recommendation System (RS) receives the results of the user profile and the information received through the personalised patient questionnaires. The system uses this input information to detect triggering situations that require recommendations to improve patients' daily lives. Observations from the devices worn by patients are converted into static data, which in turn triggers the messages of the recommendation tool.
Thanks to these 5 components, users of the TeNDER system can better understand their condition and health data monitored daily, receive alerts, notifications and personalised recommendations based on the parameters recorded in daily measurements and interactions with the mobile app, and interact in a simple way and with a personalised system. They can also contact their caregivers and professionals through the app and send them alerts in case they need help. All this will help users to improve their quality of life, maintain their autonomy and have accurate information to make their own health decisions, increasing their empowerment.
2.4. Evaluation methods
To assess the usability, user experience and acceptability of the TeNDER system, a pilot test was conducted. The test involved end-users of three types of profiles (190 patients, 167 carers and 95 professionals) from 4 countries (Spain, Germany, Italy and Slovenia). During a period ranging from 2 to 8 weeks, users were able to experiment with the system in four different scenarios (rehabilitation ward, hospital, day care centre and their own homes). After the experience they were given a post-intervention interview incorporating the following questions:
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SUS (System Usability Scale) [
20]
: The user evaluates on a Likert-type scale with 5 response options whether he/she agrees or disagrees with the following statements.
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SUS1: I think that I would like to use this system frequently.
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SUS2: I found the system unnecessarily complex.
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SUS3: I thought the system was easy to use.
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SUS4: I think that I would need the support of a technical
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SUS5: I found the various functions in this system were well integrated.
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SUS6: I thought there was too much inconsistency in this system.
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SUS7: I would imagine that most people would learn to use this system very quickly.
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SUS8: I found the system very cumbersome to use.
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SUS9: I felt very confident using the system.
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SUS10: I needed to learn a lot of things before I could get going with this system.
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Rate of satisfaction (RS): The user evaluates on a Likert-type scale with 5 response options whether he/she agrees or disagrees with the following statements. In the case of professionals, only the first two satisfaction questions were included.
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RS1: How satisfied are you with Tender system?
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RS2: Rate your experience with Tender system.
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RS3: How satisfied are you with reports about your activities and progress?
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RS4: How satisfied are you with the overview of your health status and events from TeNDER?
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Open questions to collect direct feedback: The user responds in their own words describing their experience.
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OQ1: How do you feel with TeNDER system?
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OQ2: What do you like less about TeNDER system?
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OQ3: What do you like more about TeNDER system?
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OQ4: What would you change in order to make the TeNDER System more useful and applicable for you?