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Background: Reminders via digital technology offer a novel and efficient means to address medication forgetfulness, as they are easily accessible and user-friendly for patients. In particular mobile text message reminders are more suitable for chronic patients, as they require few technical skills, can operate without internet connectivity, and are less expensive than other technologies. This study aimed to assess the intention to use mobile text message reminders for medication adherence among hypertensive patients at the Gondar City health facilities. Methods: A facility-based cross-sectional study was conducted. A simple random sampling method was used to select 423 hypertensive patients. Data was collected from April 1 to May 15, 2023. Data was collected using Kobo Toolbox, and the collected data was exported to MS Excel. Subsequently, the data was imported and analyzed using the SPSS version 20. Binary and multivariable logistic regression analysis was employed to assess factors associated with the outcome variable. Result: The finding indicates that 64.5% of the patients have an Intention to use mobile text message reminders for medication adherence. Perceived usefulness (AOR = 2.53: 95%CI: 1.41, 4.52), perceived ease of use (AOR = 3.28: 95% CI: 1.81, 5.95), forgetting to take medication (AOR = 2.20: 95%CI: 1.38, 3.50) and patient holds their mobile phone always (AOR = 1.96: 95%CI: 1.04, 3.68) were associated factors with outcome variable. Conclusion: Forget taking medication, the patient holds their mobile phone always, Perceived ease of use and Perceived usefulness were significantly associated with the outcome variable. We recommend designing and implementing user-friendly text message reminder systems and educating hypertensive patients about the system's benefits. [ABSTRACT FROM AUTHOR]

The main objective of this protocol is to understand the effectiveness of the use of a mobile application (OcupApp) to generate a personal self-analysis about meaningful activities in a population of adults aged between 50 and 70 years with low or moderate depression/anxiety. A randomised study will be carried out comparing the effects of the use of the OcupApp application with a control intervention on health-related quality of life, mental health, frequency of participation on meaningful activities, and perceived occupational balance. This is the first study to use occupational self-analysis in m-health to improve occupational balance, mental health, frequency of participation in meaningful activities and health-related quality of life. The app was co-created with a population whose characteristics are similar to those of the target users, and it was tested in both the intervention itself and the presentation, thus it is expected to be effective. Trial Registration Number: Clinical Trial B1-2020_25 IMPLICATIONS FOR REHABILITATION: This is the first study to evaluate the impact of an app on occupational participation in people older than 50 years with mild-moderate anxiety and/or depression Introducing an occupational self-analysis app that helps people become aware of their occupations can improve health-related quality of life, mental health, frequency of participation on meaningful activities, and perceived occupational balance. OcupApp will allow people to go under occupational self-analysis process from home or any other place, maintaining the principles of the original programme. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to assess the impact of Mobile health (M-health) on medication time adherence among people living with HIV/AIDS (PLWHA). Methods: The study included all PLWHA who were receiving care at the Federal University Teaching Hospital Owerri (FUTH) and Imo State Specialist Hospital (ISSH) Umugumma during the study duration. The test group (FUTH) received a 2-way text message sent three times a week and a once-a-week phone call, while the control group (ISSH) received only the standard care. Findings: The result shows that the adherence was higher among PLWHA in the test group compared to those in the control group (P = 0.000, χ2 = 168.62, 95% confidence interval (CI): 7.22 to 16.19). Conclusion: M-health intervention significantly improved the medication time adherence among the participants in the test group compared to those in the control group. [ABSTRACT FROM AUTHOR]

Issue Addressed: Australian children fall short of meeting the dietary, physical activity and sedentary behaviour guidelines. This study aimed to test the feasibility, acceptability and potential efficacy of a parental text message and social media program on, primarily, their school‐aged children's vegetable consumption and movement behaviours, and, secondarily, their own. Methods: Between August and November 2022, we conducted a two‐armed randomised controlled trial with 242 parents/caregivers of primary school‐aged children in New South Wales. The 'Adventure & Veg' intervention ran for 8 weeks, promoting vegetable eating behaviours, local outdoor physical activity opportunities and ideas for reducing screen time. Feasibility and acceptability were assessed via recruitment and retention data, intervention metrics and self‐reported participant data. Vegetable intake and movement behaviour data were collected via online‐surveys and effect sizes were examined. Results: Most participants reported that they enjoyed receiving the text messages (88%) and the delivery frequency was acceptable (94%). Limitations to Facebook as a delivery platform were reported. The majority of participants used the text messages to influence the vegetable eating (65%) and movement (77%) behaviours of their child. Significant effects were observed among intervention child participants compared with control for mean daily vegetable consumption (0.45 serves, CI:.19;.71, p =.001, d =.5); weekly vegetable variety (1.85, CI:.25; 3.45, p <.001, d =.6); and weekly physical activity variety (.64 CI:.09; 1.19, p =.022, d =.3). Parents in the intervention group increased their daily vegetable intake by.44 serves (CI:.11;.78, p =.01, d =.4). Conclusions: A parental text message and social media program has potential to support children's vegetable intake and movement behaviours. Further research is required to explore different online delivery methods to promote local outdoor activity options. So What?: The Adventure & Veg program holds promise as a stand‐alone health promotion intervention or as a useful adjunct to current family or school‐based healthy lifestyle programs. [ABSTRACT FROM AUTHOR]

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Copyright of Environmental & Social Management Journal / Revista de Gestão Social e Ambiental is the property of Environmental & Social Management Journal and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Pediatric obesity treatment is based on high-intensity lifestyle counseling. However, high dropout rates and low effectiveness have been reported, even in specialized centers. Mobile health technologies have been used to overcome these limits with contrasting results. This study aims at evaluating the effectiveness of a six-month intervention with a mobile app for the treatment of pediatric obesity at 6 and 12 months of follow-up. Methods: Seventy-five patients were randomly assigned to standard care or standard care plus mobile app (2:1) using an online randomizer system. The mobile app delivered high-intensity lifestyle counseling for diet and physical activity. Results: At six months of follow-up, the M-App group showed significantly lower dropout rates compared to standard care (p = 0.01). The risk of dropout was significantly higher in controls compared to the intervention group (OR 3.86, 95% C.I. 1.39–10.42, p = 0.01). After one year, we observed lower albeit non-statistically significant dropout rates in the M-App compared to the standard care group (p = 0.24). No differences were observed in z-score BMI and percentage of BMI reduction between the two groups. Conclusions: Our findings suggest that the mobile app might help in the clinical management of children and adolescents with obesity in terms of dropout reduction. [ABSTRACT FROM AUTHOR]

Abstract Background Reminders via digital technology offer a novel and efficient means to address medication forgetfulness, as they are easily accessible and user-friendly for patients. In particular mobile text message reminders are more suitable for chronic patients, as they require few technical skills, can operate without internet connectivity, and are less expensive than other technologies. This study aimed to assess the intention to use mobile text message reminders for medication adherence among hypertensive patients at the Gondar City health facilities. Methods A facility-based cross-sectional study was conducted. A simple random sampling method was used to select 423 hypertensive patients. Data was collected from April 1 to May 15, 2023. Data was collected using Kobo Toolbox, and the collected data was exported to MS Excel. Subsequently, the data was imported and analyzed using the SPSS version 20. Binary and multivariable logistic regression analysis was employed to assess factors associated with the outcome variable. Result The finding indicates that 64.5% of the patients have an Intention to use mobile text message reminders for medication adherence. Perceived usefulness (AOR = 2.53: 95%CI: 1.41, 4.52), perceived ease of use (AOR = 3.28: 95% CI: 1.81, 5.95), forgetting to take medication (AOR = 2.20: 95%CI: 1.38, 3.50) and patient holds their mobile phone always (AOR = 1.96: 95%CI: 1.04, 3.68) were associated factors with outcome variable. Conclusion Forget taking medication, the patient holds their mobile phone always, Perceived ease of use and Perceived usefulness were significantly associated with the outcome variable. We recommend designing and implementing user-friendly text message reminder systems and educating hypertensive patients about the system’s benefits.

Abstract Aim This study aimed to assess the impact of Mobile health (M-health) on medication time adherence among people living with HIV/AIDS (PLWHA). Methods The study included all PLWHA who were receiving care at the Federal University Teaching Hospital Owerri (FUTH) and Imo State Specialist Hospital (ISSH) Umugumma during the study duration. The test group (FUTH) received a 2-way text message sent three times a week and a once-a-week phone call, while the control group (ISSH) received only the standard care. Findings The result shows that the adherence was higher among PLWHA in the test group compared to those in the control group (P = 0.000, χ2 = 168.62, 95% confidence interval (CI): 7.22 to 16.19). Conclusion M-health intervention significantly improved the medication time adherence among the participants in the test group compared to those in the control group.

Abstract Background Interest in mental health smartphone applications has grown in recent years. Despite their effectiveness and advantages, special attention needs to be paid to two aspects to ensure app engagement: to include patients and professionals in their design and to guarantee their usability. The aim of this study was to analyse the perceived usability and quality of the preliminary version of RegulEm, an app based in the Unified Protocol, as part of the second stage of the app development. Methods A parallel mixed methods study was used with 7 professionals and 4 users who were previously involved in the first stage of the development of the app. MARS, uMARS and SUS scales were used, and two focus groups were conducted. Descriptive statistical analysis and a thematic content analysis were performed in order to gather as much information as possible on RegulEm’s usability and quality as well as suggestions for improvement. Results RegulEm’s usability was perceived through the SUS scale scores as good by users (75 points) and excellent by professionals (84.64 points), while its quality was perceived through the uMARS and MARS scales as good by both groups, with 4 and 4.14 points out of 5. Different areas regarding RegulEm’s usability and suggestions for improvement were identified in both focus groups and 20% of the suggestions proposed were implemented in the refined version of RegulEm. Conclusion RegulEm’s usability and quality were perceived as good by users and professionals and different identified areas have contributed to its refinement. This study provides a more complete picture of RegulEm’s usability and quality prior analysing its effectiveness, implementation and cost-effectiveness in Spanish public mental health units.

The impact of e-Health and m-health interventions on mental health, highlighting their potential to address psychological problems. E-health is defined as the use of information and communication technologies in support of health, while mobile health refers to the usage of mobile technologies for health purposes. Both offer benefits such as availability, accessibility, cost-effectiveness and content personalization. The effectiveness of mobile apps in improving quality of life, reducing symptoms of stress and depression, and promoting emotional well-being. The importance of integrating psychological theories into these applications is highlighted and the need for more research, especially in populations such as older adults and health workers. Accessibility and reach of psychological services through m-health are crucial, but challenges are observed in adoption and usability, especially in environments such as that of university students. The need to carefully consider the socio-cultural experiences and preferences of users when developing m-health applications is highlighted. There are three examples of interventions in Mexico, highlighting the implementation of preventive strategies for adolescents, augmented reality in psychology teaching, and a smoking cessation programme for adults. Although successful, it is recognized that there is little scientific evidence related to mobile applications in the Mexican population. It highlights the potential of mobile technology in mental health, but also points to challenges and the need for ongoing research to ensure the ethical and effective development of applications in this field.

In recent years, increasing attention has been paid to identifying new approaches to improve workplace well-being and manage stress with the help of m-health solutions. The primary purpose of this review is to provide an overview of the current use of smartphone applications integrated with wearable technologies in stress management and the promotion of well-being in the workplace. A key terms literature search was performed using multiple electronic databases. The review process followed the international PRISMA statement guidelines. A quality assessment was conducted using the Mixed Methods Appraisal Tool. A total of 25 eligible papers published between 2016 and 2023 were included. Interventions proposed were heterogeneous and primarily based on smartphone applications (72%). 84% of the interventions had background theories, with a high preference for Mindfulness. Interventions were reported as generally significant, and the combined use of smartphone applications and wearable technologies increased awareness at the individual and collective levels. In conclusion, the review demonstrates how the interventions developed through the synergy of technologies can effectively promote well-being and reduce stress in the workplace context, decreasing the stigma still related to mental health and increasing peer support strategies. This work opens the doors to several possibilities for future research. It could be interesting to indagate more in-depth the value of integration between technologies and, eventually, the integration with more traditional type of interventions, e.g., face-to-face activities, evaluating if this synergy can amplify and strengthen the results. Protocol registration: The review protocol was registered with PROSPERO: CRD42023423126 (May 2nd, 2023). [ABSTRACT FROM AUTHOR]

Background: Interest in mental health smartphone applications has grown in recent years. Despite their effectiveness and advantages, special attention needs to be paid to two aspects to ensure app engagement: to include patients and professionals in their design and to guarantee their usability. The aim of this study was to analyse the perceived usability and quality of the preliminary version of RegulEm, an app based in the Unified Protocol, as part of the second stage of the app development. Methods: A parallel mixed methods study was used with 7 professionals and 4 users who were previously involved in the first stage of the development of the app. MARS, uMARS and SUS scales were used, and two focus groups were conducted. Descriptive statistical analysis and a thematic content analysis were performed in order to gather as much information as possible on RegulEm's usability and quality as well as suggestions for improvement. Results: RegulEm's usability was perceived through the SUS scale scores as good by users (75 points) and excellent by professionals (84.64 points), while its quality was perceived through the uMARS and MARS scales as good by both groups, with 4 and 4.14 points out of 5. Different areas regarding RegulEm's usability and suggestions for improvement were identified in both focus groups and 20% of the suggestions proposed were implemented in the refined version of RegulEm. Conclusion: RegulEm's usability and quality were perceived as good by users and professionals and different identified areas have contributed to its refinement. This study provides a more complete picture of RegulEm's usability and quality prior analysing its effectiveness, implementation and cost-effectiveness in Spanish public mental health units. [ABSTRACT FROM AUTHOR]

Objective: The optimal management of placenta accreta spectrum (PAS) requires the participation of multidisciplinary teams that are often not locally available in low‐resource settings. Telehealth has been increasingly used to manage complex obstetric conditions. Few studies have explored the use of telehealth for PAS management, and we aimed evaluate the usage of telehealth in the management of PAS patients in low‐resource settings. Methods: Between March and April 2023, an observational, survey‐based study was conducted, and obstetricians‐gynecologists with expertise in PAS management in low‐ and middle‐income countries were contacted to share their opinion on the potential use of telehealth for the diagnosis and management of patients at high‐risk of PAS at birth. Participants were identified based on their authorship of at least one published clinical study on PAS in the last 5 years and contacted by email. This is a secondary analysis of the results of that survey. Results: From 158 authors contacted we obtained 65 responses from participants in 27 middle‐income countries. A third of the participants reported the use of telehealth during the management obstetric emergencies (38.5%, n = 25) and PAS (36.9%, n = 24). Over 70% of those surveyed indicated that they had used "informal" telemedicine (phone call, email, or text message) during PAS management. Fifty‐nine participants (90.8%) reported that recommendations given remotely by expert colleagues were useful for management of patients with PAS in their setting. Conclusion: Telehealth has been successfully used for the management of PAS in middle‐income countries, and our survey indicates that it could support the development of specialist care in other low resource settings. Synopsis: Most obstetricians who provide care for patients with placenta accreta spectrum in low resource settings consider telemedicine useful for management of this complex condition. [ABSTRACT FROM AUTHOR]

Introduction: Mobile applications have the potential to enhance the effective dissemination of precise information pertaining to HIV and sexual and reproductive health. The purpose of the study is a descriptive investigation aimed at assessing the validity of video-based learning media using a procedural development model. Materials and methods: The evaluation of validity was conducted by a group of specialists in the field of material and media using a product development assessment tool in the format of video-based learning materials. Results: Based on the analysis of seventeen expert evaluations, the average score obtained for the format, language, and content components was 3.53, and for four expert media evaluations, the average score obtained for the use of learning videos was 3.42. Conclusion: The mobile health education application program for mental health, HIV voluntary counseling, and testing among the deaf community is valid and can be used in the next research. [ABSTRACT FROM AUTHOR]

Background: The quantification of self-triage effectiveness, guided by mobile applications, in urgent direct-to-consumer telemedicine (TM) encounters requires further investigation. The objective of this study was to evaluate the outcomes of referral guidance provided by a symptom-based self-management mobile application decision algorithm in the context of remote urgent care assessments. Methods: An observational retrospective single-center study was conducted from May 2022 to December 2023. The inclusion criteria encompassed individuals aged >18 years old, and those spontaneously seeking virtual emergency care through the EINSTEIN CONECTA application. Patients experiencing connectivity issues, preventing completion of the encounter, were excluded. The primary outcomes included the rate of patient concurrence with the algorithm's recommendation for seeking in-person emergency care and the referral rate to face-to-face assessment among cases evaluated through TM. The application's algorithm employs scientific evidence based on symptoms to recommend referrals to emergency departments (EDs). Results: Out of 88,834 patients connected to the TM Center, self-triage obviated the need for virtual physician assessment in 53,302 (60%) encounters. A total of 35,532 patients were remotely evaluated by 316 on-duty physicians, resulting in 1,125 ICD-coded diagnoses. Among these, 21,722 (61.1%) were initially advised by self-triage to visit the ED, with subsequent medical assessment leading to in-person referrals in 6,354 (29.3%) of the evaluations. Of the 13,810 patients recommended to continue with virtual care post-self-triage, 157 (1.1%) were referred for in-person assessment. Conclusions: Self-triage effectively reduced the need for physician encounters in approximately three-fifths of TM consultations. Despite being based on scientific evidence, symptom-based referral algorithms demonstrated high sensitivity but poor correlation with physician decision-making. [ABSTRACT FROM AUTHOR]

Purpose: Strabismus is a common ocular condition requiring precise quantification of gaze deviation and qualification of strabismus category. Telemedicine refers to the use of technology to remotely diagnose and treat medical conditions. This narrative review aimed to assess the efficacy of a variety of telemedicine modalities for the assessment of strabismus. A secondary objective was to quantify overall accuracy, sensitivity, and specificity of automated methods using meta-analysis of available data. Methods: A literature search was conducted using the Ovid MEDLINE, Embase, and Cochrane Library data libraries. Keywords, including "strabismus," "phoria," "telemed*," and "telehealth," were used to locate relevant studies, with Medical Subject Headings terms, free text, and synonyms. No year restrictions were applied. Studies not in English were excluded. Risk of bias was assessed using the QUADAS-2 tool. Results: Thirty-four studies were included. All outcomes relating to accuracy and reliability of telemedicine versus a reference standard were extracted, as well as qualitative observations. High sensitivity, specificity, accuracy, and agreement were consistently shown across studies. Meta-analysis of two subsets featuring automated methods, for which relevant data were available, revealed a pooled accuracy of 0.877 (0.806–0.949), sensitivity of 0.856 (0.805–0.907), and specificity of 0.900 (0.845–0.954). Subcategories "remote standard assessment," "digital image analysis," "wearable devices," "mobile health (mHealth)," and "artificial intelligence" were independently examined. Conclusions: The majority of systems achieved parity with standard physician assessment, with the added benefit of eliminating subjectivity. Meta-analysis results suggest potential introduction of remote automated assessment where conventional assessment is unavailable, although accuracy of current technologies remains limited compared to in-person examination. Telemedicine modalities described offer convenience for patients, shorter examination times, and the potential to go beyond in-person assessments. The evidence gathered in this review supports the beginning of telemedicine integration into the world of strabismus diagnosis. [ABSTRACT FROM AUTHOR]

People with minor medical conditions in China tend to prefer healthcare consultation in the emergency department of tertiary hospitals and avoid public sector community health centers (PS-CHC). The reason behind this is the trust deficit in the quality of medical care at PS-CHC. On the other hand, Chinese m-health companies have a surprising number of registered users and daily healthcare queries. However, the lack of physical check-ups causes a lack of trust in the quality of prescribed treatments for m-health users. One such m-health company entered into a joint venture with a local government body. In this joint venture, the doctors from tertiary hospitals can provide healthcare consultation to m-health users at PS-CHC. This study investigates m-health users' intention to use m-health services equipped with PS-CHC, an emerging public-private joint venture in China. We extended the technology acceptance model with government support and trust to predict the adoption of such technology-based public-private joint ventures in a better way. The data were collected from 432 m-health users in Hefei and analyzed using Smart-PLS. All eight direct, but only three mediating relationships were to be found significant. This study has implications for researchers, government healthcare authorities, and m-health service providers. [ABSTRACT FROM AUTHOR]

The Ministry of Health of the Republic of Indonesia has issued Surat Edaran Menteri Kesehatan Republik Indonesia Nomor Hk.02.01/Menkes/303/2020 Tahun 2020 as a preventive measure in the form of face-to-face health services by utilizing information and communication technology in the form of telemedicine. Telemedicine has the advantage of making it easier for patients to get health services remotely. However, there are still shortcomings in implementing telemedicine services in providing health services during the Covid-19 pandemic in Indonesia. The aim of the research is to determine the obstacles to telemedicine services in Indonesia during the Covid-19 pandemic. This research uses a literature review method by searching for articles using databases, namely PubMed, Google Scholar, Portal Garuda, UI Scholars, UI Scholars Hub, and Jurnal Administrasi Kesehatan Indonesisa (JAKI) which were published in 2020-2023. Keywords used in the article search process are Telemedicine, Telehealth, Mobile Health, Covid-19, and Indonesia. There were 378 articles obtained, but 8 articles met the inclusion criteria. The results of the literature study show that the implementation of telemedicine services has the advantages of providing long-distance consultations and drug prescriptions by professional doctors, saving costs, and being a credible source of information. However, obstacles are also found in telemedicine services such as lack of knowledge, attitudes and trust of patients towards telemedicine, patient interest in using telemedicine services, failure of network infrastructure and internet connectivity, accuracy of diagnosis and policies in case of misdiagnosis or malpractice, security of medical records and privacy of patient data, and not all types of diseases can be examined online and still require a direct physical examination. [ABSTRACT FROM AUTHOR]

BACKGROUND: People with disabilities face challenges in daily life during the COVID-19 pandemic, including limited access to care, exposure to lifestyle-related diseases, and difficulties in regular exercise. Therefore, it is important to establish health safety nets using Information and Communication Technology (ICT) in communities. OBJECTIVE: This study aimed to develop an m-Health-based personalized lifestyle intervention algorithm targeting high-risk groups of lifestyle-related diseases (including hypertension, diabetes, and obesity) among people with hemiplegic disabilities, and to verify its feasibility. METHODS: Six people at a high risk of lifestyle-related diseases participated in an 8-week lifestyle intervention using a wearable device and the S-Health program. The self-health management areas included walking, moderate-intensity exercise, weight, blood pressure, blood sugar, diet, calorie intake, heart rate, sobriety, no smoking. Health, physical, psychological, and social changes were measured before and after the study. RESULTS: The intervention had a positive impact on the participants' health, with statistically significant differences found in fasting blood glucose, highest systolic blood pressure, grip strength, and motor function assessment. Quality of life, health-related quality of life, and self-efficacy improved post-intervention. CONCLUSION: Our findings can be used as preliminary evidence for establishing m-Health-based health safety net systems for people with disabilities who live in communities. [ABSTRACT FROM AUTHOR]

This study aims to investigate the effect of e-service quality (ESQ) in m-Health application on loyalty (LOY), focusing on the mediating customer satisfaction (SAT) and the moderating role of gender and domicile area on user loyalty. The study used quantitative research and the population of this study was m-Health application users with 260 respondents using the purposive sampling method. The analysis method used is PROCESS Macro Mediated Moderation Model 14 by SPSS 29. The results indicate that e-service quality positively and significantly affects user loyalty. Additionally, e-service quality has a positive and significant impact on consumer satisfaction and also the quality of consumer satisfaction has a positive and significant impact on loyalty. The study also found that customer satisfaction mediates the relationship of e-service quality on user loyalty. However, the demographic variables, gender, and domicile area were found have no impact on the relationship between consumer satisfaction and loyalty. [ABSTRACT FROM AUTHOR]

IntroductionAnxiety and depression are major causes of disability in Arab countries, yet resources for mental health services are insufficient. Mobile devices may improve mental health care delivery (mental m-Health), but the Arab region's mental m-Health app landscape remains under-documented. This study aims to systematically assess the features, quality, and digital safety of mental m-Health apps available in the Arab marketplace. We also contrast a set of recommended Australian apps to benchmark current strategies and evidence-based practices and suggest areas for improvement in Arabic apps.MethodsFifteen Arab country-specific iOS Apple Stores and an Android Google Play Store were searched. Apps that met the inclusion criteria were downloaded and evaluated using the Mobile App Rating Scale (MARS) and the Mobile App Development and Assessment Guide (MAG).ResultsTwenty-two apps met the inclusion criteria. The majority of apps showed no evidence of mental health experts being involved in the app design processes. Most apps offered real-time communication with specialists through video, text, or audio calls rather than evidence-based self-help techniques. Standardized quality assessment showed low scores for design features related to engagement, information, safety, security, privacy, usability, transparency, and technical support. In comparison to apps available in Australia, Arabic apps did not include evidence-based interventions like CBT, self-help tools and crisis-specific resources, including a suicide support hotline and emergency numbers.DiscussionIn conclusion, dedicated frameworks and strategies are required to facilitate the effective development, validation, and uptake of Arabic mental mHealth apps. Involving end users and healthcare professionals in the design process may help improve app quality, dependability, and efficacy.

Abstract Background Exercise and medication have similar benefits in reducing blood pressure (BP); however, hypertension management initiatives primarily focus on medicines. This is due to scarce research on the effectiveness of implementation strategies for optimal exercise adoption and adherence. Smartphones were found to be effective in delivering hypertension care and increase exercise adherence. Despite this, only a small number of research projects in India have used smartphones as a strategy for managing hypertension. Methods We hypothesized that smartphone application‐based care would lead to higher exercise adherence among adults (30–79 years) with hypertension compared to those who receive usual care. It will be a multicentric, randomized controlled, parallel‐design, superiority clinical trial. The outcome assessor and data analyst will be blinded to group allocation. Participants in the intervention group will receive mobile application‐based care for 6 weeks. Participants in the usual care group will receive a standard intervention. Both groups will receive the same number of follow‐ups. Results The primary outcome is the difference in the proportion of people adherent to the recommended level of physical activity evaluated using an exercise adherence rating scale in the intervention group and the control group. Exercise adoption will be measured as the percentage of eligible participants in each study setting willing to initiate the exercise program. The secondary outcome includes differences in systolic and diastolic BP and self‐management (evaluated using the Hypertension Self‐Care Profile). The trial outcome will be accompanied by a process evaluation. Conclusions This research will inform about the comparative effectiveness of conventional and m‐health interventions for exercise adoption and adherence in people with hypertension in resource‐constrained settings.

Abstract Background None of the early M-Health applications are designed for case management care services. This study aims to describe the process of developing a M-health component for the case management model in breast cancer transitional care and to highlight methods for solving the common obstacles faced during the application of M-health nursing service. Methods We followed a four-step process: (a) Forming a cross-functional interdisciplinary development team containing two sub-teams, one for content development and the other for software development. (b) Applying self-management theory as the theoretical framework to develop the M-health application, using contextual analysis to gain a comprehensive understanding of the case management needs of oncology nursing specialists and the supportive care needs of out-of-hospital breast cancer patients. We validated the preliminary concepts of the framework and functionality of the M-health application through multiple interdisciplinary team discussions. (c) Adopting a multi-stage optimization strategy consisting of three progressive stages: screening, refining, and confirmation to develop and continually improve the WeChat mini-programs. (d) Following the user-centered principle throughout the development process and involving oncology nursing specialists and breast cancer patients at every stage. Results Through a continuous, iterative development process and rigorous testing, we have developed patient-end and nurse-end program for breast cancer case management. The patient-end program contains four functional modules: “Information”, “Interaction”, “Management”, and “My”, while the nurse-end program includes three functional modules: “Consultation”, “Management”, and “My”. The patient-end program scored 78.75 on the System Usability Scale and showed a 100% task passing rate, indicating that the programs were easy to use. Conclusions Based on the contextual analysis, multi-stage optimization strategy, and interdisciplinary team work, a WeChat mini-program has been developed tailored to the requirements of the nurses and patients. This approach leverages the expertise of professionals from multiple disciplines to create effective and evidence-based solutions that can improve patient outcomes and quality of care.

Abstract Introduction Neuromuscular diseases (NMDs) entail a group of mostly inherited genetic disorders with heterogeneous phenotypes impacting muscles, the central or peripheral nervous system. They can lead to severe disabilities and shortened lifespans. Despite their severity, NMDs often lack in public awareness and appropriate medical and social support. Telemedicine can improve patients’ and caregivers’ lives by enhancing continuity of and access to care. The first aim of this systematic review was to summarise the status quo of telemedicine services for patients with NMDs. Secondly, barriers and facilitators of the respective implementation processes should be analysed. Methods The databases PubMed, Web of Science and CENTRAL by Cochrane were searched in May 2022. To be truly explorative, any original evidence from any setting was included. Two independent researchers completed the screening process. Data was extracted and analysed using the taxonomy of Bashshur et al. (2011) and the Consolidated Framework for Implementation Research (CFIR). Results Fifty-seven original papers were included in the systematic review. The results showed a high representation of teleconsultations and remote monitoring studies. Teleconsultations replaced in person appointments and telemonitoring mostly focused on ventilation. Physical therapy, pulmonology, neurology, and psychology were the most represented medical specialties. We found barriers and facilitators relating to implementation mainly referred to the intervention and the individuals involved. Technical errors and inaccessibility due to a lack of technical devices or the patient’s disability were stated as hindrances. A positive mindset of users as well as patient empowerment were necessary for the adoption of new technology. Technophobia or uncertainty around technology negatively impacted the implementation process. Discussion This systematic review provides an overview of the current use of telemedicine in patients with NMDs. The distribution of telemedicine interventions between the defined domains was very heterogenous. Previous research has neglected to fully describe the implementation process of telemedicine for NMDs. Conclusion The evidence shows that telemedicine can benefit patients with NMDs in a multitude of ways. Therefore, health policies should endorse and incentivise the uptake of telemedicine by institutions and health care workers. Further research needs to be conducted to confirm the current evidence and close existing research gaps.

The paper analyzes the approach to one very important phenomenon in the modern environment, which is defined as digital transformation in the healthcare system. The increasing influx of digital technologies into business processes leads to the point where the provision of healthcare services can no longer be viewed only in traditional frameworks, but it is necessary to look at the unlimited options of digital technologies, digital content and digital communications in the provision of healthcare services. The needs of the healthcare system and certain changes resulting from the development of communication and information technologies such as the Internet, social networks, mobile applications, etc. require organized work on the implementation of a strategy for new ways of doing business in healthcare. Health information and early screening awareness of oncological diseases increase the motivation for active participation of people in the implementation of preventive measures, treatments and rehabilitation. [ABSTRACT FROM AUTHOR]

Introduction: The increase in the use of mobile apps since the COVID-19 pandemic, even among people with multiple sclerosis (PwMS) and health care providers (HCPs), has enabled access to reliable information, symptoms monitoring and management, and social connections. The pandemic has undoubtedly contributed to the acceleration of the "digital revolution." But how far has it progressed for the MS communities? Methods: Italian Google Play and App Store were queried, selecting MS-specific apps in English or Italian language and usable by a wide public. Results:Fifty-four (n = 54) MS-specific apps were identified; most were PwMS-oriented (83%), free of charge (94%), and in English language (76%). The 45 PwMS-oriented apps focused on increasing MS knowledge (71%), tracking symptoms (33%), and promoting networking with peers or HCPs (38%). The 13 HCPs-oriented tools addressed education and updates on MS (62%), disease assessment and management (54%), and research (15%). Google Search tool was also queried to find non-MS–specific apps to fulfill some unmet domains (as sleep, pain, sexual or mental health). Twenty-four additional apps were listed to provide a valuable contribution. Conclusion: The "digital revolution" led to increasingly customized tools for PwMS, especially as m-health or social-networking apps. However, apps to support other specific MS-relevant domains, appealing HCPs-oriented apps, and specific mobile tools for MS caregivers are still lacking. The absence of data assessing the usability and quality of MS apps in ecologically contexts leads to not reliable conclusions about potential benefits. A strong dialogue between MS communities and the digital industry is encouraged to fill this gap. [ABSTRACT FROM AUTHOR]

A healthy lifestyle comprising regular physical activity and an adequate diet is imperative for the prevention of non‐communicable diseases such as hypertension and some cancers. Advances in information computer technology offer the opportunity to provide personalised lifestyle advice directly to the individual through devices such as smartphones or tablets. The overall aim of the PROTEIN project (Wilson‐Barnes et al., 2021) was to develop a smartphone application that could provide tailored and dynamic nutrition and physical activity advice directly to the individual in real time. However, to create this mobile health (m‐health) smartphone application, a knowledge base of reference ranges for macro‐/micronutrient intake, anthropometry, biochemical, physiological and sleep parameters was required to underpin the parameters of the recommender systems. Therefore, the principal aim of this emerging research paper is to describe the process by which experts in nutrition and physiology from the PROTEIN consortium collaborated to develop the nutritional and physical activity requirements, based upon existing recommendations, for 10 separate population groups living within the EU including, but not limited to healthy adults, adults with type 2 diabetes mellitus, cardiovascular disease, excess weight, obesity and iron deficiency anaemia. A secondary aim is to describe the development of a library of 24‐h meal plans appropriate for the same groups and also encompassing various dietary preferences and allergies. Overall, the consortium devised an extensive nutrition and physical activity knowledge base that is pertinent to 10 separate EU user groups, is available in 7 different languages and is practically implemented via a library of culturally appropriate, 24‐h meal plans. [ABSTRACT FROM AUTHOR]

Health and exercise technology may promote a healthy lifestyle during pregnancy. The objective of this cross-sectional study was to understand and involve the perspective of pregnant women as users in the design of a framework for future e-health and exercise interventions during pregnancy. Pregnant women replied to a questionnaire aimed at understanding their physical activity patterns, needs, and preferences regarding the use of mobile applications (apps). The main results showed that one-third of the women did not practice any type of exercise during pregnancy. Women preferred to exercise in a gym, outdoors, or at home. The majority already had or were currently using a fitness app, but never used any pregnancy-specific app. Most women agreed that it was important to have a specific app for pregnancy to improve knowledge about recommendations on lifestyle, have direct contact with health and exercise professionals, have social interaction with other mothers, and have guidance on preparation for childbirth and postpartum recovery. Understanding and involving the perspective of pregnant women as users will allow researchers to improve the design of a pregnancy-specific app and future e-health and exercise interventions during pregnancy. These preliminary results will lead to the development of the "active pregnancy app" focused on the promotion of an active and healthy lifestyle during pregnancy and postpartum. [ABSTRACT FROM AUTHOR]

Introduction: Neuromuscular diseases (NMDs) entail a group of mostly inherited genetic disorders with heterogeneous phenotypes impacting muscles, the central or peripheral nervous system. They can lead to severe disabilities and shortened lifespans. Despite their severity, NMDs often lack in public awareness and appropriate medical and social support. Telemedicine can improve patients' and caregivers' lives by enhancing continuity of and access to care. The first aim of this systematic review was to summarise the status quo of telemedicine services for patients with NMDs. Secondly, barriers and facilitators of the respective implementation processes should be analysed. Methods: The databases PubMed, Web of Science and CENTRAL by Cochrane were searched in May 2022. To be truly explorative, any original evidence from any setting was included. Two independent researchers completed the screening process. Data was extracted and analysed using the taxonomy of Bashshur et al. (2011) and the Consolidated Framework for Implementation Research (CFIR). Results: Fifty-seven original papers were included in the systematic review. The results showed a high representation of teleconsultations and remote monitoring studies. Teleconsultations replaced in person appointments and telemonitoring mostly focused on ventilation. Physical therapy, pulmonology, neurology, and psychology were the most represented medical specialties. We found barriers and facilitators relating to implementation mainly referred to the intervention and the individuals involved. Technical errors and inaccessibility due to a lack of technical devices or the patient's disability were stated as hindrances. A positive mindset of users as well as patient empowerment were necessary for the adoption of new technology. Technophobia or uncertainty around technology negatively impacted the implementation process. Discussion: This systematic review provides an overview of the current use of telemedicine in patients with NMDs. The distribution of telemedicine interventions between the defined domains was very heterogenous. Previous research has neglected to fully describe the implementation process of telemedicine for NMDs. Conclusion: The evidence shows that telemedicine can benefit patients with NMDs in a multitude of ways. Therefore, health policies should endorse and incentivise the uptake of telemedicine by institutions and health care workers. Further research needs to be conducted to confirm the current evidence and close existing research gaps. [ABSTRACT FROM AUTHOR]

Background:Growth of international travel to malarial areas over the last decades has contributed to more travelers taking malaria prophylaxis. Travel-related symptoms may be wrongly attributed to malaria prophylaxis and hinder compliance. Here, we aimed to assess the frequency of real-time reporting of symptoms by travelers following malaria prophylaxis using a smartphone app. Method:Adult international travelers included in this single-center study (Barcelona, Spain) used the smartphone Trip Doctor® app developed by our group for real-time tracking of symptoms and adherence to prophylaxis. Results:Six hundred four (n = 604) international travelers were included in the study; 74.3% (449) used the app daily, and for one-quarter of travelers, malaria prophylaxis was prescribed. Participants from the prophylaxis group traveled more to Africa (86.7% vs. 4.3%; p < 0.01) and to high travel medical risk countries (60.8% vs. 18%; p < 0.01) and reported more immunosuppression (30.8% vs. 23.1% p < 0.01). Regarding symptoms, no significant intergroup differences were observed, and no relationship was found between the total number of malarial pills taken and reported symptoms. Conclusions:In our cohort, the number of symptoms due to malaria prophylaxis was not significantly higher than in participants for whom prophylaxis was not prescribed, and the overall proportion of symptoms is higher compared with other studies. [ABSTRACT FROM AUTHOR]

The HIV/AIDS pandemic is a global issue that has unequally affected several countries. Due to the complexity of this condition and the human drama it represents to those most affected by it, several fields have contributed to solving or at least alleviating this situation, and the information systems (IS) field has not been absent from these efforts. With the importance of antiretroviral therapy (ART) as a starting point, several initiatives in the IS field have focused on ways to improve the adherence and effectiveness of this therapy: mobile phone reminders (for pill intake and appointments), and mobile interfaces between patients and health workers are popular contributions. However, many of these solutions have been difficult to implement or deploy in some countries in the Global South, which are among the most affected by this pandemic. This paper presents one such case. Using a case‐study approach with an extreme‐case selection technique, the paper studies an m‐health system for HIV patients in the Kalangala region of Uganda. Using Heeks' design—reality gap model for data analysis, the paper shows that the rich interaction between social context and technology should be considered a central concern when designing or deploying such systems. [ABSTRACT FROM AUTHOR]

In recent years, the integration of game-like elements into non-gaming contexts has shown promise in enhancing user engagement and motivation. This study assesses the impact of gamification elements on data collection efficacy in mhealth applications. An ad-hoc mobile application was developed and used in a randomized two-arm pilot study. Participants interacted either with the gamified meal-logging application or with its non-gamified version for ten days. The results from this study emphasize the benefits of incorporating gamification techniques into health applications embedded in digital platforms. While both versions were wellreceived, reaching high System Usability Scale (SUS) scores (91 and 93.5) and generally positive feedback, the gamified app demonstrated a distinct advantage in promoting user engagement and consistent data logging. This highlights the importance of gamification in health research, suggesting its potential to ensure thorough and consistent data collection, which is essential for producing reliable research outcomes. [ABSTRACT FROM AUTHOR]

Purpose of Review: To review randomized controlled trials (RCTs) published from 2021–2023 that reported the effects of peer support interventions on outcomes in patients with type 2 diabetes (T2DM). Recent Findings: Literature searches yielded 137 articles and nine RCTs were ultimately reviewed. The reviewed trials involved in-person support groups, peer coach/mentor support, cultural peer support by community health workers, peer support during shared medical appointments (SMAs) including virtual reality-based SMAs, telehealth-facilitated programs, and telephone peer support. Most interventions combined two or more peer support strategies. Peer support was associated with significant decreases in HbA1c in 6 of the 9 reviewed studies. The largest statistically significant improvements in HbA1c were reported in a study of community health workers in Asia (-2.7% at 12 months) and a Canadian study in which trained volunteer peer coaches with T2DM met with participants once and subsequently made weekly or biweekly phone calls to them (-1.35% at 12 months). Systolic blood pressure was significantly improved in 3 of 9 studies. Summary: The findings suggest that peer support can be beneficial to glycemic control and blood pressure in T2DM patients. Studies of peer support embedded within SMAs resulted in significant reductions in HbA1c and suggest that linkages between healthcare systems, providers, and peer support programs may enhance T2DM outcomes. [ABSTRACT FROM AUTHOR]

Many people are unaware of the severity of melanoma disease even though such a disease can be fatal if not treated early. This research aims to facilitate the diagnosis of melanoma disease in people using a mobile health application because some people do not prefer to visit a dermatologist due to several concerns such as feeling uncomfortable by exposing their bodies. As such, a skincare application was developed so that a user can easily analyze a mole at any part of the body and get the diagnosis results quickly. In the first phase, the corresponding image is extracted and sent to a web service. Later, the web service classifies using the pre-trained model built based on a deep learning algorithm. The final phase displays the confidence rates on the mobile application. The proposed model utilizes the Convolutional Neural Network and provides 84% accuracy and 72% precision. The results demonstrate that the proposed model and the corresponding mobile application provide remarkable results for addressing the specified health problem. [ABSTRACT FROM AUTHOR]

This paper presents the design, implementation and validation of a novel fitness mobile application called CalAid, aimed at promoting an active lifestyle, in the context of ever growing sedentarism in population of all ages. The application uses sensors present in most modern smartphones such as motion sensors, the 3-axial accelerometer, the gyroscope and the step counter in order to track energy expenditure and to obtain a more precise approximation of consumed calories. By using machine learning we can recognize the activities performed by the application client and, using metabolic equivalents, find the energy expenditure. [ABSTRACT FROM AUTHOR]

Efficacious, effective and efficient communication between healthcare professionals (HCP) and patients is essential to achieve a successful therapeutic alliance. Telemedicine (TM) has been used for decades but during the COVID‐19 pandemic its use has become widespread. This position paper aims to describe the terminology and most important forms of TM among HCP and patients and review the existing studies on the uses of TM for asthma and allergy. Besides, the advantages and risks of TM are discussed, concluding that TM application reduces costs and time for both, HCP and patients, but cannot completely replace face‐to‐face visits for physical examinations and certain tests that are critical in asthma and allergy. From an ethical point of view, it is important to identify those involved in the TM process, ensure confidentiality and use communication channels that fully guarantee the security of the information. Unmet needs and directions for the future regarding implementation, data protection, privacy regulations, methodology and efficacy are described. [ABSTRACT FROM AUTHOR]

The migration of federal assistance services to online platforms during the COVID-19 pandemic sparked interest in digital nutrition education for individuals participating in the Supplemental Nutrition Assistance Program (SNAP) and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) programs. With federal government investing in the modernization of the nutrition education components of both programs, there is a need to identify science-backed electronic health (e-health) dietary interventions to improve health outcomes in this population. Therefore, the objective of this systematic literature review was to summarize the effectiveness, acceptability, and feasibility of e-health dietary interventions among individuals participating in WIC or SNAP. Keyword searches were performed in Google Scholar, PubMed, and Science Direct. The search included peer-reviewed literature from 2014 to 2023 and a few articles offering context about interventions used long-term by the nutrition assistance programs. PRISMA guidelines were followed to conduct this systematic literature review, which resulted in 36 articles eligible for extraction. The studies evaluated e-health (52.8%), short message service/text messaging (27.8%), and smartphone application interventions (19.4%) delivered to WIC or SNAP participants. The interventions identified aimed to modify food choice, eating behavior, and dietary intake among SNAP participants, SNAP-eligible adults, and WIC participants. Most interventions were developed using content delivery and health behavior theoretical frameworks (77.8%) and evidence-based nutritional recommendations (59.3%). Review findings show a high level of acceptability and feasibility for e-health and mobile health dietary interventions among WIC and SNAP participants but varying levels of effectiveness. Level of engagement, dosage, retention, and adherence were strong predictors of positive dietary behavior change regardless of the mode of intervention delivery. Future studies need to prioritize health equity by recruiting samples representative of food nutrition assistance participants and addressing digital health literacy as a potential barrier to intervention effectiveness, as none of the present studies measured literacy among participants. [ABSTRACT FROM AUTHOR]

This study was based on the Kano model and rely on the Internet hospital to build a day surgery patient full-process nursing service platform. Based on the Internet hospital's HIS system, nursing Yuanzhuo system, patient mobile terminal (WeChat) and other information systems. The platform was designed by following the WHO's conceptual framework for developing a scaling-up strategy. It was tested and refined by a pilot in a hospital in China. The full-process care platform for day surgery patients realizes information interconnection and interoperability of patient surgical consultation, surgical inquiries, and postoperative follow-up. It consists of a WeChat applet (client) and an online website (server). Pre-experiment results show that patients are more likely to recommend the hospital's day surgery to others. The mHealth-based perioperative full-process nursing service platform for day surgery patients can initially meet the health education needs, surgical consultation needs and follow-up needs of day surgery patients. [ABSTRACT FROM AUTHOR]

Summary: Background: Contact tracing was described as a key strategy to contribute to controlling the spread of severe acute respiratory syndrome of Coronavirus 2 (SARS-CoV-2) but implementing it can be a challenge. Digitalisation of contact tracing is among the proposed solutions being explored in sub-Saharan African settings. We assessed the effectiveness of a digital tool to expand SARS-CoV-2 testing in exposed individuals in Cameroon. Methods: We conducted a cluster-randomised (1:1) trial in eight health districts, including 22 facilities and SARS-CoV-2 testing units, randomly assigned to a digital (intervention) or standard (control) contact tracing approach. The intervention consisted of a contact tracing module added to the digital platform “Mamal PRO” used for monitoring and coordination of Coronavirus Disease 2019 pandemic response in Cameroon. The primary outcome was the proportion of contacts declared by SAR-CoV-2 index patients who were successfully traced and tested for SARS-CoV-2 evaluated with a Poisson regression model with cluster adjustment. This study is registered with ClinicalTrials.gov (NCT05684887). Findings: Between October 18, 2022, and March 31, 2023, we enrolled 164 index patients in the intervention arm and 149 in the control arm, who identified 854 and 849 contacts, respectively. In the intervention arm, 93.8% (801/854) of identified contacts were successfully reached by the tracing unit versus 54.5% (463/849) in the control arm. The intervention significantly increased the likelihood of successfully tracing contacts (adjusted relative risks (RR) 1.72 [95% CI: 1.00–2.95], p = 0.049). The median (interquartile range, IQR) time to successfully tracing contacts was 0 days [IQR: 0, 1] in the intervention and 1 day [IQR: 0, 2] in the control arm. In the intervention arm, 21.3% (182/854) of identified contacts received SARS-CoV-2 testing compared to 14.5% (123/849) in the control arm (adjusted RR 1.47 [95% CI: 0.44–4.90], p = 0.530). Interpretation: Digitalising the contact tracing process improved exposure notification and facilitated the tracing of a greater number of contacts of individuals infected with SARS-CoV-2 in resource-limited settings. Funding: The study was funded by FIND, United Kingdom (FCDO 40105983), Switzerland (81066910), Netherlands (SDD 4000004160), Canada (DFATD 7429348), The Kingdom of Saudi Arabia (FIND—ACT-A DX PARTNERSHIP 20.08.2020), The Rockefeller Foundation (2020 HTH 059), Germany (BMZ Covid-19 Diagnostic and Surveillance Response 27.07.2021), Australia (DFAT 76442), Kuwait (M239/2020), The Government of Portugal and Partners (ANF, BCP, CGF, APIFARMA) and The BlackRock Foundation (Grant Agreement as of April 20, 2022).

Abstract Background The increasing prevalence of childhood obesity has become an urgent public health problem, evidence showed that intervention for childhood obesity bring enormous health benefits. However, an effective individualized intervention strategy remains to be developed, and the accompanying remission of related complications, such as nonalcoholic fatty liver disease (NAFLD), needs to be assessed. This study aimed to develop an m-Health-assisted lifestyle intervention program targeting overweight/obese children and assess its effectiveness on indicators of adiposity and NAFLD. Methods This is a cluster-randomized controlled trial that conducted in children with overweight/obesity in Ningbo city, Zhejiang Province, China. Students in Grade 3 (8–10 years old) were recruited from six primary schools, with three be randomized to intervention group and three to usual practice group. The intervention program will last for one academic year and consists of health education, dietary guidance, and physical activity reinforcement. This program is characterized by encouraging four stakeholders, including School, Clinic, famIly, and studENT (SCIENT), to participate in controlling childhood obesity, assisted by m-Health technology. Assessments will be conducted at baseline and 3 months, 9 months, 24 months, and 36 months after baseline. The primary outcome will be the differences between the two groups in students’ body mass index and fatty liver index at the end of the intervention (9 months after baseline). During the implementation process, quality control methods will be adopted. Discussion The program will test the effectiveness of the m-Health-assisted lifestyle intervention on children with obesity and NAFLD. The results of this study will provide evidence for establishing effective lifestyle intervention strategy aimed at childhood obesity and NAFLD and may help develop guidelines for the treatment of obesity and NAFLD in Chinese children. Trial registration Clinicaltrials.gov NCT05482191. Registered on July 2022.