A Remote Monitoring System to Optimize the Home Management of Oral Anticancer Therapies (ONCO-TreC): Prospective Training-Validation Trial.

BACKGROUND: A platform designed to support the home management of oral anticancer treatments and provide a secure web-based patient-health care professional communication modality, ONCO-TreC, was tested in 3 cancer centers in Italy. OBJECTIVE: The overall aims of the trial are to customize the platform; assess the system's ability to facilitate the shared management of oral anticancer therapies by patients and health professionals; and evaluate system usability and acceptability by patients, caregivers, and health care professionals. METHODS: Patients aged ≥18 years who were candidates for oral anticancer treatment as monotherapy with an Eastern Cooperative Oncology Group performance status score of 0 to 1 and a sufficient level of familiarity with mobile devices were eligible. ONCO-TreC consisted of a mobile app for patients and a web-based dashboard for health care professionals. Adherence to treatment (pill count) and toxicities reported by patients through the app were compared with those reported by physicians in medical records. Usability and acceptability were evaluated using questionnaires. RESULTS: A total of 40 patients were enrolled, 38 (95%) of whom were evaluable for adherence to treatment. The ability of the system to measure adherence to treatment was high, with a concordance of 97.3% (95% CI 86.1%-99.9%) between the investigator and system pill count. Only 60% (3/5) of grade 3, 54% (13/24) of grade 2, and 19% (7/36) of grade 1 adverse events reported by physicians in the case report forms were also reported in the app directly by patients. In total, 94% (33/35) of patients had ≥1 app launch each week, and the median number of daily accesses per patient was 2. Approximately 71% (27/38) and 68% (26/38) of patients used the app for messages and vital sign entering, respectively, at least once during the study period. CONCLUSIONS: ONCO-TreC is an important tool for measuring and monitoring adherence to oral anticancer drugs. System usability and acceptability were very high, whereas its reliability in registering toxicity could be improved. TRIAL REGISTRATION: ClinicalTrials.gov NCT02921724; https://www.clinicaltrials.gov/ct2/show/NCT02921724.

Assessment of Psychological Distress in Adults With Type 2 Diabetes Mellitus Through Technologies: Literature Review.

BACKGROUND: The use of technological devices can support the self-management of individuals with type 2 diabetes mellitus (T2DM), particularly in addressing psychological distress. However, there is poor consistency in the literature regarding the use of psychological instruments for the web-based screening of patients' psychological distress and subsequent monitoring of their psychological condition during digital interventions. OBJECTIVE: This study aims to review previous literature on the types of psychological instruments delivered in digital interventions for assessing depression, anxiety, and stress in patients with T2DM. METHODS: The literature review was conducted using the PsycINFO, CINAHL and PubMed databases, in which the following terms were considered: diabetes mellitus, measure, assessment, self-care, self-management, depression, anxiety, stress, technology, eHealth, mobile health, mobile phone, device, and smartphone. RESULTS: In most studies, psychological assessments were administered on paper. A few studies deployed self-reporting techniques employing automated telephonic assessment, a call system for screening and monitoring patients' conditions and preferences, or through telephone interviews via interactive voice response calls, a self-management support program leveraging tailored messages and structured emails. Other studies used simple telephone interviews and included the use of apps for tablets and smartphones to assess the psychological well-being of patients. Finally, some studies deployed mood rating scales delivered through tailored text message-based support systems. CONCLUSIONS: The deployment of appropriate psychological tools in digital interventions allows researchers and clinicians to make the screening of anxiety, stress, and depression symptoms faster and easier in patients with T2DM. Data from this literature review suggest that mobile health solutions may be preferred tools to use in such digital interventions.

TreC platform. An integrated and evolving care model for patients' empowerment and data repository.

INTRODUCTION: Health care has been deeply revolutionized by the new wave of information and communication technology (ICT) development, particularly related to the electronic/personal health record (PHR). The present paper describes the original design and implementation approach followed in the Trentino Province (Italy) to promote an Integrated Care Model for patients' empowerment and data repository, by means of an evolving Personal Health Record - PHR platform, named TreC (Trentino Citizens Clinical Record). MATERIALS AND METHODS: The TreC Platform is conceived as a communication hub among different stakeholders. The core assumption of the TreC platform strategy is to consider the citizen/patient as main manager and owner of both his/her own health and his/her contacts with the health care systems. RESULTS: Over the years, the TreC platform has represented the core pillar in the digitalization process promoted at Province level. This has been strategically embedded in the multi-faceted e-government strategy endorsed by the Province of Trento. So far (October 2018), more than 89,000 citizens within the Province of Trento are using TreC platform as a way to communicate with the health care system and access their own personal health records. CONCLUSIONS: The experience gained through the TreC platform implementation and its results are promising, supporting the idea that a PHR platform can represent a key driving factor in improving health care quality and efficiency, both from a patient and a health care staff perspective.

Using Geocaching to Promote Active Aging: Qualitative Study.

BACKGROUND: Over the past few years, the development of technologies supporting active aging has been increasing. Among the activities that promote physical exercise by using technologies is geocaching-a treasure hunt of sorts in which participants use a receiver GPS to hide or find real or virtual objects. Although this activity is particularly suited to the promotion of healthy lifestyles in older people, geocaching remains to be unexplored in this area. OBJECTIVE: This study aimed to investigate the effectiveness of activities combining geocaching and self-tracking technologies to promote active aging, evaluate the usability of technologies, and explore the ways in which technologies have been integrated in the organizational context under examination to determine the user experience of participants. METHODS: A group of individuals aged 65 years and older (N=14) attending a senior center managed by a social cooperative was involved in the study. Some of them created the geocaching contents, and others, split into 2 teams, participated in the game. Each participant was given a pedometer bracelet and the geocaching app. The steps taken by individual participants along with the number of caches found by each group translated into team scores. RESULTS: The main results of the study were as follows: (1) activities in favor of active aging that involve the use of new technologies can foster the participation of elderly people; in particular, adding gamification to self-tracking can be a valid strategy to promote physical exercise among the elderly; (2) for this to happen, involvement of older people firsthand is crucial, and there must be a focus on their active involvement and empowerment in every phase of the project; and (3) the mediation of conflicts and competition that arise from the gamification could only take place because of the strong support of the organization in the form of social workers. CONCLUSIONS: The results show that promoting active aging through technologies requires more effort than simply using these tools; it requires a wider process that involves an articulated organizational network with heterogeneous actors, technologies, and relations.

Integrating mHealth in Oncology: Experience in the Province of Trento.

BACKGROUND: The potential benefits of the introduction of electronic and mobile health (mHealth) information technologies, to support the safe delivery of intravenous chemotherapy or oral anticancer therapies, could be exponential in the context of a highly integrated computerized system. OBJECTIVE: Here we describe a safe therapy mobile (STM) system for the safe delivery of intravenous chemotherapy, and a home monitoring system for monitoring and managing toxicity and improving adherence in patients receiving oral anticancer therapies at home. METHODS: The STM system is fully integrated with the electronic oncological patient record. After the prescription of chemotherapy, specific barcodes are automatically associated with the patient and each drug, and a bedside barcode reader checks the patient, nurse, infusion bag, and drug sequence in order to trace the entire administration process, which is then entered in the patient's record. The usability and acceptability of the system was investigated by means of a modified questionnaire administered to nurses. The home monitoring system consists of a mobile phone or tablet diary app, which allows patients to record their state of health, the medications taken, their side effects, and a Web dashboard that allows health professionals to check the patient data and monitor toxicity and treatment adherence. A built-in rule-based alarm module notifies health care professionals of critical conditions. Initially developed for chronic patients, the system has been subsequently customized in order to monitor home treatments with capecitabine or sunitinib in cancer patients (Onco-TreC). RESULTS: The STM system never failed to match the patient/nurse/drug sequence association correctly, and proved to be accurate and reliable in tracing and recording the entire administration process. The questionnaires revealed that the users were generally satisfied and had a positive perception of the system's usefulness and ease of use, and the quality of their working lives. The pilot studies with the home monitoring system with 43 chronic patients have shown that the approach is reliable and useful for clinicians and patients, but it is also necessary to pay attention to the expectations that mHealth solutions may raise in users. The Onco-TreC version has been successfully laboratory tested, and is now ready for validation. CONCLUSIONS: The STM and Onco-TreC systems are fully integrated with our complex and composite information system, which guarantees privacy, security, interoperability, and real-time communications between patients and health professionals. They need to be validated in order to confirm their positive contribution to the safer administration of anticancer drugs.

Personalized Virtual Reality Compared With Guided Imagery for Enhancing the Impact of Progressive Muscle Relaxation Training: Pilot Randomized Controlled Trial.

BACKGROUND: Empirical evidence has shown that virtual reality (VR) scenarios can increase the effects of relaxation techniques, reducing anxiety by enabling people to experience emotional conditions in more vivid settings. OBJECTIVE: This pilot randomized controlled study aims to investigate whether the progressive muscle relaxation technique (PMRT) associated with a personalized scenario in VR promotes psychological well-being and facilitates the recall of relaxing images more than the standard complementary intervention that involves the integration of PMRT and guided imagery (GI). METHODS: On the basis of a longitudinal, between-subject design, 72 university students were randomly exposed to one of two experimental conditions: (1) standard complementary procedure (PMRT and GI exposure) and (2) experimental procedure (PMRT and personalized VR exposure). Individuals were assessed by a therapist before and after 7 training sessions based on measures investigating anxiety, depression, quality of life, coping strategies, sense of presence, engagement, and side effects related to VR exposure. Heart rate data were also collected. RESULTS: Differences in changes between the 2 groups after the in vivo PMRT session conducted by the psychotherapist (T1) were statistically significant for state anxiety (F1,67=30.56; P<.001) and heart rate (F1,67=4.87; P=.01). Individuals in the VR group obtained lower scores both before (t67=-2.63; P=.01; Cohen d=0.91) and after (t67=-7.23; P<.001; Cohen d=2.45) the relaxation session when it was self-administered by participants (T2). A significant reduction in perceived state anxiety at T1 and T2 was observed for both groups (P<.001). After the VR experience, individuals reported feeling higher engagement in the experience than what was mentioned by participants in the GI group (F1,67=2.85; P=.03; ηp2=0.15), and they experienced the environment as more realistic (F1,67=4.38; P=.003; ηp2=0.21). No differences between groups regarding sense of presence were found (F1,67=1.99; P=.11; ηp2=0.11). Individuals exposed before to the VR scenario (T1) referred to perceiving the scenario recalled in-imagination at T2 as more realistic than what those in the GI group experienced (F1,67=3.21; P=.02; ηp2=0.12). The VR group had lower trait anxiety levels than the GI group after the relaxation session during session 7 (T2; t67=-2.43; P=.02). CONCLUSIONS: Personalized relaxing VR scenarios can contribute to improving relaxation and decreasing anxiety when integrated with PMRT as a complementary relaxation method. TRIAL REGISTRATION: ClinicalTrials.gov NCT05478941; https://classic.clinicaltrials.gov/ct2/show/NCT05478941. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/44183.

A Mindfulness-Based App Intervention for Pregnant Women: Protocol for a Pilot Feasibility Study.

BACKGROUND: Pregnancy is a complex time characterized by major transformations in a woman, which impact her physical, mental, and social well-being. How a woman adapts to these changes can affect her quality of life and psychological well-being. The literature indicates that pregnant women commonly experience psychological symptoms, with anxiety, stress, and depression being among the most frequent. Hence, promoting a healthy lifestyle focused on women's psychological well-being is crucial. Recently developed digital solutions have assumed a crucial role in supporting psychological well-being in physiologically pregnant women. Therefore, the need becomes evident for the development and implementation of digital solutions, such as a virtual coach implemented in a smartphone, as a support for the psychological well-being of pregnant women who do not present psychological and psychiatric disorders. OBJECTIVE: This study aims to assess the feasibility, acceptability, and utility of a mindfulness-based mobile app. The primary objective is to explore the feasibility of using a virtual coach, Maia, developed within the TreC Mamma app to promote women's psychological well-being during pregnancy through a psychoeducational module based on mindfulness. Finally, through the delivery of this module, the level of psychological well-being will be explored as a secondary objective. METHODS: This is a proof-of-concept study in which a small sample (N=50) is sufficient to achieve the intended purposes. Recruitment will occur within the group of pregnant women belonging to the pregnancy care services of the Trento Azienda Provinciale per i Servizi Sanitari di Trento. The convenience sampling method will be used. Maia will interact with the participating women for 8 weeks, starting from weeks 24 and 26 of pregnancy. Specifically, there will be 2 sessions per week, which the woman can choose, to allow more flexibility toward her needs. RESULTS: The psychoeducational pathway is expected to lead to significant results in terms of usability and engagement in women's interactions with Maia. Furthermore, it is anticipated that there will be improvements in psychological well-being and overall quality of life. The analysis of the data collected in this study will be mainly descriptive, orientated toward assessing the achievement of the study objectives. CONCLUSIONS: Literature has shown that women preferred web-based support during the perinatal period, suggesting that implementing digital interventions can overcome barriers to social stigma and asking for help. Maia can be a valuable resource for regular psychoeducational support for women during pregnancy. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/53890.

Personalized, Naturalistic Virtual Reality Scenarios Coupled With Web-Based Progressive Muscle Relaxation Training for the General Population: Protocol for a Proof-of-Principle Randomized Controlled Trial.

BACKGROUND: Virtual reality (VR) is an innovative tool that can facilitate exposure to either stressful or relaxing stimuli and enables individuals who have difficulties visualizing scenes to be involved in a more realistic sensorimotor experience. It also facilitates multisensory stimulation, a sense of presence, and achievement of relaxation. VR scenarios representing visual and auditory elements of natural relaxing environments can facilitate the learning of relaxation techniques such as the progressive muscle relaxation technique (PMRT). A complementary standardized technique deployed to reduce anxiety symptoms is the integration of PMRT and guided imagery (GI). Exposure to a pleasant imaginary environment helps the establishment of an association between a relaxing scenario and the relaxation technique, consequently promoting relaxation. Empirical evidence has shown that VR scenarios can increase the effects of relaxation techniques by enabling people to experience emotional conditions in more vivid settings. OBJECTIVE: The main aim of this pilot study protocol is to investigate the impact on state anxiety of PMRT, associated with a personalized relaxing scenario in VR, and the role of VR scenarios in facilitating the recall of relaxing images and a sense of presence. A secondary aim is to understand if relaxing sessions administered via Zoom are more effective for managing anxiety and stress than a procedural setting based on audio-track guidance. METHODS: Based on a longitudinal, between-subject design, 108 university students will be randomly exposed to one of three experimental conditions: (1) PMRT via Zoom and GI exposure, (2) PMRT via Zoom and personalized VR exposure, and (3) PMRT based on audio-track guidance and personalized VR exposure. Individuals are assessed before and after 7 training sessions based on self-report questionnaires investigating anxiety, depression, quality of life, coping strategies, sense of presence, engagement, and side effects related to VR exposure. Heart rate data are also detected by an Mi Band 2 sensor. RESULTS: The experimental procedure is ongoing. In this paper, preliminary data from a sample of 40 participants will be illustrated. The experimental phase is expected to conclude in May 2023, and the final results of the research will be presented in June 2023. CONCLUSIONS: The results of this study will help shape the experimental design to apply it on a subsequent randomized controlled trial, also considering clinical samples. This work is expected to measure whether VR is a more engaging and helpful technique in promoting relaxation and decreasing anxiety levels than GI, by making the visualization process easier and by helping people to face more realistic sensory experiences. Assessing the efficacy of the PMRT in alternative delivery modes may extend its applications, especially in situations where the standard procedure is more challenging to be administered. To our knowledge, no equivalent study has been published so far on this matter. TRIAL REGISTRATION: ClinicalTrials.gov NCT05478941; https://clinicaltrials.gov/ct2/show/NCT05478941. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44183.

Customized virtual reality naturalistic scenarios promoting engagement and relaxation in patients with cognitive impairment: a proof-of-concept mixed-methods study.

Being immersed in a natural context has a beneficial and pervasive impact on well-being. Virtual Reality (VR) is a technology that can help expose people to naturalistic scenarios virtually, overcoming obstacles that prevent them from visiting real natural environments. VR could also increase engagement and relaxation in older adults with and without cognitive impairment. The main aim of this study is to investigate the feasibility of a customized naturalistic VR scenario by assessing motion-sickness effects, engagement, pleasantness, and emotions felt. Twenty-three individuals with a diagnosis of cognitive impairment living in a long-term care home participated in our study. At the end of the entire VR experimental procedure with older adults, five health staff operators took part in a dedicated assessment phase focused on evaluating the VR procedure's usability from their individual perspectives. The tools administered were based on self-reported and observational tools used to obtain information from users and health care staff professionals. Feasibility and acceptance proved to be satisfactory, considering that the VR experience was well-tolerated and no adverse side effects were reported. One of the major advantages emerged was the opportunity to deploy customized environments that users are not able to experience in a real context.Trial Registration: National Institute of Health (NIH) U.S. National Library of Medicine, ClinicalTrials.gov NCT05863065 (17/05/2023).

The Role of Personalization in the User Experience, Preferences and Engagement with Virtual Reality Environments for Relaxation.

Virtual Reality Environments (VREs) are widely deployed in mental health treatments, often associated with relaxation techniques. The personalization of natural VR-based scenarios is a key element that can further facilitate users' sense of presence and relaxation. This study explored the role of VREs' personalization in the user experience with an environment supporting relaxation, by deploying mixed methods. METHODS: A non-clinical sample of 20 individuals participated in exposure to a supportive body-scan-guided relaxation VRE. In the personalized conditions, the participants had the option of choosing the context (e.g., sea, mountain, or countryside) and including in the scenario different types of sounds, visual elements, and changing the time of day and weather. In the standard conditions, individuals were exposed to a relaxing VRE, but they could choose neither the context nor the auditory and visual elements. The order of presentation of the personalized vs non-personalized environments was randomized. Measures regarding relaxation, state-anxiety perceived levels, VRE-related symptoms, the usability of the Virtual Reality (VR) setting, sense of presence, pleasure, activation, engagement, and level of immersion experienced were collected before and after exposure to the VR environments. RESULTS: Findings showed that personalized VREs were preferred by users. Participants generally preferred to experience a greater immersivity, pleasure, engagement, and relaxation in the personalized virtual settings. CONCLUSION: The study further confirms the role of personalization as a component positively contributing to relaxation and engagement. Future research may further assess this effect in the context of large-scale controlled studies involving clinical and non-clinical populations.

Early Development of a Virtual Coach for Healthy Coping Interventions in Type 2 Diabetes Mellitus: Validation Study.

BACKGROUND: Mobile health solutions aimed at monitoring tasks among people with diabetes mellitus (DM) have been broadly applied. However, virtual coaches (VCs), embedded or not in mobile health, are considered valuable means of improving patients' health-related quality of life and ensuring adherence to self-care recommendations in diabetes management. Despite the growing need for effective, healthy coping digital interventions to support patients' self-care and self-management, the design of psychological digital interventions that are acceptable, usable, and engaging for the target users still represents the main challenge, especially from a psychosocial perspective. OBJECTIVE: This study primarily aims to test VC interventions based on psychoeducational and counseling approaches to support and promote healthy coping behaviors in adults with DM. As a preliminary study, university students have participated in it and have played the standardized patients' (SPs) role with the aim of improving the quality of the intervention protocol in terms of user acceptability, experience, and engagement. The accuracy of users' role-playing is further analyzed. METHODS: This preliminary study is based on the Obesity-Related Behavioral Intervention Trial model, with a specific focus on its early phases. The healthy coping intervention protocol was initially designed together with a team of psychologists following the main guidelines and recommendations for psychoeducational interventions for healthy coping in the context of DM. The protocol was refined with the support of 3 experts in the design of behavioral intervention technologies for mental health and well-being, who role-played 3 SPs' profiles receiving the virtual coaching intervention in a Wizard of Oz setting via WhatsApp. A refined version of the healthy coping protocol was then iteratively tested with a sample of 18 university students (mean age 23.61, SD 1.975 years) in a slightly different Wizard of Oz evaluation setting. Participants provided quantitative and qualitative postintervention feedback by reporting their experiences with the VC. Clustering techniques on the logged interactions and dialogs between the VC and users were collected and analyzed to identify additional refinements for future VC development. RESULTS: Both quantitative and qualitative analyses showed that the digital healthy coping intervention was perceived as supportive, motivating, and able to trigger self-reflection on coping strategies. Analyses of the logged dialogs showed that most of the participants accurately played the SPs' profile assigned, confirming the validity and usefulness of this testing approach in preliminary assessments of behavioral digital interventions and protocols. CONCLUSIONS: This study outlined an original approach to the early development and iterative testing of digital healthy coping interventions for type 2 DM. Indeed, the intervention was well-accepted and proved its effectiveness in the definition and refinement of the initial protocol and of the user experience with a VC before directly involving real patients in its subsequent use and testing.

A Virtual Coach (Motibot) for Supporting Healthy Coping Strategies Among Adults With Diabetes: Proof-of-Concept Study.

BACKGROUND: Motivation is a core component of diabetes self-management because it allows adults with diabetes mellitus (DM) to adhere to clinical recommendations. In this context, virtual coaches (VCs) have assumed a central role in supporting and treating common barriers related to adherence. However, most of them are mainly focused on medical and physical purposes, such as the monitoring of blood glucose levels or following a healthy diet. OBJECTIVE: This proof-of-concept study aims to evaluate the preliminary efficacy of a VC intervention for psychosocial support before and after the intervention and at follow-up. The intent of this VC is to motivate adults with type 1 DM and type 2 DM to adopt and cultivate healthy coping strategies to reduce symptoms of depression, anxiety, perceived stress, and diabetes-related emotional distress, while also improving their well-being. METHODS: A total of 13 Italian adults with DM (18-51 years) interacted with a VC, called Motibot (motivational bot) using the Telegram messaging app. The interaction covered 12 sessions, each lasting 10 to 20 minutes, during which the user could dialogue with the VC by inputting text or tapping an option on their smartphone screen. Motibot is developed within the transtheoretical model of change to deliver the most appropriate psychoeducational intervention based on the user's motivation to change. RESULTS: Results showed that over the 12 sessions, there were no significant changes before and after the intervention and at follow-up regarding psychosocial factors. However, most users showed a downward trend over the 3 time periods in depression and anxiety symptoms, thereby presenting good psychological well-being and no diabetes-related emotional distress. In addition, users felt motivated, involved, encouraged, emotionally understood, and stimulated by Motibot during the interaction. Indeed, the analyses of semistructured interviews, using a text mining approach, showed that most users reported a perceived reduction in anxiety, depression, and/or stress symptoms. Moreover, users indicated the usefulness of Motibot in supporting and motivating them to find a mindful moment for themselves and to reflect on their own emotions. CONCLUSIONS: Motibot was well accepted by users, particularly because of the inclusion of mindfulness practices, which motivated them to adopt healthy coping skills. To this extent, Motibot provided psychosocial support for adults with DM, particularly for those with mild and moderate symptoms, whereas those with severe symptoms may benefit more from face-to-face psychotherapy.

Digital Technologies and the Role of Health Care Professionals: Scoping Review Exploring Nurses' Skills in the Digital Era and in the Light of the COVID-19 Pandemic.

BACKGROUND: The nursing role significantly changed following reforms in the nurse training process. Nowadays, nurses are increasingly trained to promote and improve the quality of clinical practice and to provide support in the assistance of patients and communities. Opportunities and threats are emerging as a consequence of the introduction of new disruptive technologies in public health, which requires the health care staff to develop new digital skills. OBJECTIVE: The aim of this paper is to review and define the role of nurses and the skills they are asked to master in terms of new methodological approaches and digital knowledge in a continuously evolving health care scenario that relies increasingly more on technology and digital solutions. METHODS: This scoping review was conducted using a thematic summary of previous studies. Authors collected publications through a cross-database search (PubMed, Web of Science, Google Scholar) related to new telemedicine approaches impacting the nurses' role, considering the time span of 2011-2021 and therefore including experiences and publications related to the first phase of the COVID-19 pandemic. RESULTS: The assessment was completed between April and July 2021. After a cross-database search, authors reviewed a selection of 60 studies. The results obtained were organized into 5 emerging macro areas: (1) leadership (nurses are expected to show leadership capabilities when introducing new technologies in health care practices, considering their pivotal role in coordinating various professional figures and the patient), (2) soft skills (new communication skills, adaptiveness, and problem solving are needed to adapt the interaction to the level of digital skills and digital knowledge of the patient), (3) training (specific subjects need to be added to nursing training to boost the adoption of new communication and technological skills, enabling health care professionals to largely and effectively use new digital tools), (4) remote management of COVID-19 or chronic patients during the pandemic (a role that has proved to be fundamental is the community and family nurse and health care systems are adopting novel assistance models to support patients at home and to enable decentralization of services from hospitals to the territory), and (5) management of interpersonal relationships with patients through telemedicine (a person-centered approach with an open and sensitive attitude seems to be even more important in the framework of telemedicine where a face-to-face session is not possible and therefore nonverbal indicators are more problematic to be noticed). CONCLUSIONS: Further advancing nurses' readiness in adopting telemedicine requires an integrated approach, including combination of technical knowledge, management abilities, soft skills, and communication skills. This scoping review provides a wide-ranging and general-albeit valuable-starting point to identify these core competences and better understand their implications in terms of present and future health care professionals' roles.

Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial.

INTRODUCTION: ONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours. METHODS AND ANALYSIS: This is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher's exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs. ETHICS AND DISSEMINATION: Ethical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. PROTOCOL VERSION: Version 2, 6 April 2021. TRIAL REGISTRATION NUMBER: NCT04826458.

Implementation of tele visit healthcare services triggered by the COVID-19 emergency: the Trentino Province experience.

AIM: In response to the SARS-CoV-2 emergency, the Competence Centre on digital health 'TrentinoSalute4.0' has developed TreC_Televisita, a tele visit solution that meets the needs of the Trentino healthcare system and maintains high-quality patient-doctor interactions while respecting social distancing. This paper highlights how 'TreC_Televisita' was integrated into the Trentino healthcare system and its potential to become a structural and durable solution for the future local healthcare service provisioning. SUBJECT AND METHODS: This paper presents the multifactorial context that TreC_Televisita has faced for its implementation and the strategies adopted for its structural integration into the healthcare system. The analysis focuses on the main issues faced for the integration of the tele visits (e.g. privacy, payments) and how the context of TrentinoSalute4.0 permitted responding quickly to its implementation during the pandemic. It also describes how TreC_Televisita fits into the healthcare continuum from the organisational and technological standpoint, the end-user perspective and the barriers that could hamper the solution scalability. RESULTS: TreC_Televisita has demonstrated to be a technological solution that can be contextualised for different clinical domains beyond SARS-CoV-2. Moreover, it has shown its potential to scale up the solution beyond the COVID-19 emergency to the whole healthcare provisioning system in the long term. CONCLUSION: Being a positive experience in the first months of its implementation, the long-term goal is to transform TreC_Televisita into a structural pillar of the Trentino healthcare system, setting the bases for a sustainable, win-win situation for all the stakeholders involved in healthcare service provisioning.

Engagement and Effectiveness of a Healthy-Coping Intervention via Chatbot for University Students During the COVID-19 Pandemic: Mixed Methods Proof-of-Concept Study.

BACKGROUND: University students are increasingly reporting common mental health problems, such as stress, anxiety, and depression, and they frequently face barriers to seeking psychological support because of stigma, cost, and availability of mental health services. This issue is even more critical in the challenging time of the COVID-19 pandemic. Digital mental health interventions, such as those delivered via chatbots on mobile devices, offer the potential to achieve scalability of healthy-coping interventions by lowering cost and supporting prevention. OBJECTIVE: The goal of this study was to conduct a proof-of-concept evaluation measuring the engagement and effectiveness of Atena, a psychoeducational chatbot supporting healthy coping with stress and anxiety, among a population of university students. METHODS: In a proof-of-concept study, 71 university students were recruited during the COVID-19 pandemic; 68% (48/71) were female, they were all in their first year of university, and their mean age was 20.6 years (SD 2.4). Enrolled students were asked to use the Atena psychoeducational chatbot for 4 weeks (eight sessions; two per week), which provided healthy-coping strategies based on cognitive behavioral therapy, positive psychology, and mindfulness techniques. The intervention program consisted of conversations combined with audiovisual clips delivered via the Atena chatbot. Participants were asked to complete web-based versions of the 7-item Generalized Anxiety Disorder scale (GAD-7), the 10-item Perceived Stress Scale (PSS-10), and the Five-Facet Mindfulness Questionnaire (FFMQ) at baseline and postintervention to assess effectiveness. They were also asked to complete the User Engagement Scale-Short Form at week 2 to assess engagement with the chatbot and to provide qualitative comments on their overall experience with Atena postintervention. RESULTS: Participants engaged with the Atena chatbot an average of 78 (SD 24.8) times over the study period. A total of 61 out of 71 (86%) participants completed the first 2 weeks of the intervention and provided data on engagement (10/71, 14% attrition). A total of 41 participants out of 71 (58%) completed the full intervention and the postintervention questionnaires (30/71, 42% attrition). Results from the completer analysis showed a significant decrease in anxiety symptoms for participants in more extreme GAD-7 score ranges (t39=0.94; P=.009) and a decrease in stress symptoms as measured by the PSS-10 (t39=2.00; P=.05) for all participants postintervention. Participants also improved significantly in the describing and nonjudging facets, based on their FFMQ subscale scores, and asked for some improvements in the user experience with the chatbot. CONCLUSIONS: This study shows the benefit of deploying a digital healthy-coping intervention via a chatbot to support university students experiencing higher levels of distress. While findings collected during the COVID-19 pandemic show promise, further research is required to confirm conclusions.

Educational Intervention of Healthy Life Promotion for Children with a Migrant Background or at Socioeconomic Disadvantage in the North of Italy: Efficacy of Telematic Tools in Improving Nutritional and Physical Activity Knowledge.

The aim of the "Smuovi La Salute" ("Shake Your Health") project was to implement an integrated and comprehensive model to prevent and treat overweight and obesity in low socioeconomic status (SES) and minority groups living in three different districts in the north of Italy. An app and a cookbook promoting transcultural nutrition and a healthy lifestyle were developed, and no-cost physical activities were organized. Healthy lifestyle teaching was implemented in 30 primary school classrooms. Learning was assessed through pre- and post-intervention questionnaires. At the Obesity Pediatric Clinic, overweight and obese children of migrant background or low SES were trained on transcultural nutrition and invited to participate in the project. Primary school students increased their knowledge about healthy nutrition and the importance of physical activity (p-value < 0.001). At the Obesity Pediatric Clinic, after 6 months, pre-post-intervention variation in their consumption of vegetables and fruit was +14% (p < 0.0001) and no variation in physical activity habits occurred (p = 0.34). In this group, the BMI z-score was not significantly decreased (-0.17 ± 0.63, p= 0.15). This study demonstrates the feasibility and efficacy of telematic tools and targeted community approaches in improving students' knowledge with regard to healthy lifestyle, particularly in schools in suburbs with a high density of migrants and SES families. Comprehensive and integrated approaches provided to the obese patients remain mostly ineffective.

Use of eHealth Platforms and Apps to Support Monitoring and Management of Home-Quarantined Patients With COVID-19 in the Province of Trento, Italy: App Development and Implementation.

BACKGROUND: Italy was the first country to largely experience the COVID-19 epidemic among other Western countries during the so-called first wave of the COVID-19 pandemic. Proper management of an increasing number of home-quarantined individuals created a significant challenge for health care authorities and professionals. This was especially true when considering the importance of remote surveillance to detect signs of disease progression and consequently regulate access to hospitals and intensive care units on a priority basis. OBJECTIVE: In this paper, we report on an initiative promoted to cope with the first wave of the COVID-19 epidemic in the Spring/Summer of 2020, in the Autonomous Province of Trento, Italy. A purposefully built app named TreCovid19 was designed to provide dedicated health care staff with a ready-to-use tool for remotely monitoring patients with progressive symptoms of COVID-19, who were home-quarantined during the first wave of the epidemic, and to focus on those patients who, based on their self-reported clinical data, required a quick response from health care professionals. METHODS: TreCovid19 was rapidly developed to facilitate the monitoring of a selected number of home-quarantined patients with COVID-19 during the very first epidemic wave. The app was built on top of an existing eHealth platform, already in use by the local health authority to provide home care, with the following functionalities: (1) to securely collect and link demographic and clinical information related to the patients and (2) to provide a two-way communication between a multidisciplinary health care team and home-quarantined patients. The system supported patients to self-assess their condition and update the multidisciplinary team on their health status. The system was used between March and June 2020 in the province of Trento. RESULTS: A dedicated multidisciplinary group of health care professionals adopted the platform over a period of approximately 3 months (from March-end to June 2020) to monitor a total of 170 patients with confirmed COVID-19 during home quarantine. All patients used the system until the end of the initiative. The TreCovid19 system has provided useful insights of possible viability and impact of a technological-organizational asset to manage a potentially critical workload for the health care staff involved in the periodic monitoring of a relevant number of quarantined patients, notwithstanding its limitations given the rapid implementation of the whole initiative. CONCLUSIONS: The technological and organizational model adopted in response to the COVID-19 pandemic was developed and finalized in a relatively short period during the initial few weeks of the epidemic. The system successfully supported the health care staff involved in the periodic monitoring of an increasing number of home-quarantined patients and provided valuable data in terms of disease surveillance.

Design of a Mobile App for Nutrition Education (TreC-LifeStyle) and Formative Evaluation With Families of Overweight Children.

BACKGROUND: Nutrition and diet apps represent today a popular area of mobile health (mHealth), offering the possibility of delivering behavior change (BC) interventions for healthy eating and weight management in a scalable and cost-effective way. However, if commercial apps for pediatric weight management fail to retain users because of a lack of theoretical background and evidence-based content, mHealth apps that are more evidence-based are found less engaging and popular among consumers. Approaching the apps development process from a multidisciplinary and user-centered design (UCD) perspective is likely to help overcome these limitations, raising the chances for an easier adoption and integration of nutrition education apps within primary care interventions. OBJECTIVE: The aim of this study was to describe the design and development of the TreC-LifeStyle nutrition education app and the results of a formative evaluation with families. METHODS: The design of the nutrition education intervention was based on a multidisciplinary UCD approach, involving a team of BC experts, working with 2 nutritionists and 3 pediatricians from a primary care center. The app content was derived from evidence-based knowledge founded on the Food Pyramid and Mediterranean Diet guidelines used by pediatricians in primary care. A formative evaluation of the TreC-LifeStyle app involved 6 families of overweight children (aged 7-12 years) self-reporting daily food intake of children for 6 weeks and providing feedback on the user experience with the mHealth intervention. Analysis of the app's usage patterns during the intervention and of participants' feedback informed the refinement of the app design and a tuning of the nutrition education strategies to improve user engagement and compliance with the intervention. RESULTS: Design sessions with the contribution of pediatricians and nutritionists helped define the nutrition education app and intervention, providing an effective human and virtual coaching approach to raise parents' awareness about children's eating behavior and lifestyle. The 6 families participating in the pilot study found the app usable and showed high compliance with the intervention over the 6 weeks, but analysis of their interaction and feedback showed the need for improving some of the app features related to the BC techniques "monitoring of the behavior" and "information provision." CONCLUSIONS: The UCD and formative evaluation of TreC-LifeStyle show that nutrition education apps are feasible and acceptable solutions to support health promotion interventions in primary care.

Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study.

INTRODUCTION: Despite the growing number of oral agents available for cancer treatment, their efficacy may be reduced due to the lack of adherence, inappropriate adverse event self-management and arbitrary dose adjustment. The management of anticancer therapies could exponentially benefit from the introduction of mobile health technologies in a highly integrated electronic oncology system. METHODS AND ANALYSIS: We plan to customise and fine-tune an existing monitoring TreC platform used in different chronic diseases in the oncology setting. This project follows a multistep approach with two major purposes: 1. participatory design techniques driven by Health Literacy and Patient Reported Outcomes principles in order to adapt the system to the oncology setting involving patients and healthcare providers; 2. a prospective training-validation, interventional, non-pharmacological, multicentre study on a series of consecutive patients with cancer (20 and 60 patients in the training and validation steps, respectively) in order to assess system capability, usability and acceptability. The novel Onco-TreC 2.0 is expected to contribute to improving the adherence and safety of cancer care, promoting patient empowerment and patient-doctor communication. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Independent Ethics Committees of the participating institutions (CEIIAV protocol Number 2549/2015; reference Number 1315-PU). Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT02921724); (Pre-results). Other study ID Number: IRST100.18.