OBJECTIVE: To investigate the efficacy of the integrated data platform of cloud hospital combined with dietary management for adults with type 2 diabetes.
METHODS: We conducted a randomized controlled clinical trial. One hundred eighty patients with type 2 diabetes were randomly allocated into a control group (Group A) and an experimental group (Group B). Routine standard diabetes care was applied to the patients in Group A. The integrated data platform with dietary management was applied to Group B. Individualized diabetes education videos were sent to the patients through the platform. The primary endpoint was the change in HbA1c and change in body weight from baseline to Week 12 during the follow-up.
RESULTS: At Week 12, HbA1c was 7.4 ± 0.7%, 6.9 ± 0.9% in Groups A and B, P < 0.01. The rate of fasting blood glucose <7 mmol/L, and glycosylated hemoglobin <7% was higher in Group B than in Group A. At Week 12, there was a significant weight loss and body mass index decrease in the overweight or obese patients of the experimental group. Those overweight or obese patients in the experimental group utilizing the appetite suppressant semaglutide achieved the most significant weight loss, with a 13.4% reduction after 12 weeks.
CONCLUSIONS: The integrated data platform combined with personalized diabetes education video delivery was verified to be a more effective management mode for diabetes. For overweight or obese adults with diabetes, the use of semaglutide in conjunction with dietary management and the integrated data platform led to greater weight loss.

BACKGROUND: Alzheimer disease (AD) and AD-related dementia are prevalent concerns for aging populations. With a growing older adult population living in the United States, the number of people living with dementia is expected to grow, posing significant challenges for informal caregivers. The mental and physical burdens associated with caregiving highlight the importance of developing novel and effective resources to support caregivers. However, technology solutions designed to address their needs often face low adoption rates due to usability issues and a lack of contextual relevance. This study focuses on developing a web-based platform providing financial and legal planning information and education for dementia caregivers and evaluating the platform\'s usability and adoptability.
OBJECTIVE: The goal of this project is to create a web-based platform that connects caregivers with personalized and easily accessible resources. This project involves industrial, academic, and community partners and focuses on two primary aims: (1) developing a digital platform using a Dementia Care Personalization Algorithm and assessing feasibility in a pilot group of caregivers, and (2) evaluating the acceptability and usability of the digital platform across different racial or ethnic populations. This work will aid in the development of technology-based interventions to reduce caregiver burden.
METHODS: The phase I study follows an iterative Design Thinking approach, involving at least 25 dementia caregivers as a user feedback panel to assess the platform\'s functionality, aesthetics, information, and overall quality using the adapted Mobile Application Rating Scale. Phase II is a usability study with 300 dementia caregivers in Texas (100 African American, 100 Hispanic or Latinx, and 100 non-Hispanic White). Participants will use the digital platform for about 4 weeks and evaluate its usefulness and ease of use through the Technology Acceptance Survey.
RESULTS: The study received funding from the National Institute on Aging on September 3, 2021. Ethical approval for phase I was obtained from the Texas A&M University Institutional Review Board on December 8, 2021, with data collection starting on January 1, 2022, and concluding on May 31, 2022. Phase I results were published on September 5, 2023, and April 17, 2024, respectively. On June 21, 2023, ethical approval for human subjects for phase II was granted, and participant recruitment began on July 1, 2023.
CONCLUSIONS: Upon completing these aims, we expect to deliver a widely accessible digital platform tailored to assist dementia caregivers with financial and legal challenges by connecting them to personalized, contextually relevant information and resources in Texas. If successful, we plan to work with caregiving organizations to scale and sustain the platform, addressing the needs of the growing population living with dementia.
UNASSIGNED: DERR1-10.2196/64127.

BACKGROUND: Heart failure (HF) is a burdensome condition and a leading cause of 30-day hospital readmissions in the United States. Clinical and social factors are key drivers of hospitalization. These 2 strategies, digital platforms and home-based social needs care, have shown preliminary effectiveness in improving adherence to clinical care plans and reducing acute care use in HF. Few studies, if any, have tested combining these 2 strategies in a single intervention.
OBJECTIVE: This study aims to perform a pilot randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of a 30-day digitally-enabled community health worker (CHW) intervention in HF.
METHODS: Adults hospitalized with a diagnosis of HF at an academic hospital were randomly assigned to receive digitally-enabled CHW care (intervention; digital platform +CHW) or CHW-enhanced usual care (control; CHW only) for 30 days after hospital discharge. Primary outcomes were feasibility (use of the platform) and acceptability (willingness to use the platform in the future). Secondary outcomes assessed preliminary effectiveness (30-day readmissions, emergency department visits, and missed clinic appointments).
RESULTS: A total of 56 participants were randomized (control: n=31; intervention: n=25) and 47 participants (control: n=28; intervention: n=19) completed all trial activities. Intervention participants who completed trial activities wore the digital sensor on 78% of study days with mean use of 11.4 (SD 4.6) hours/day, completed symptom questionnaires on 75% of study days, used the blood pressure monitor 1.1 (SD 0.19) times/day, and used the digital weight scale 1 (SD 0.13) time/day. Of intervention participants, 100% responded very or somewhat true to the statement \"If I have access to the [platform] moving forward, I will use it.\" Some (n=9, 47%) intervention participants indicated they required support to use the digital platform. A total of 19 (100%) intervention participants and 25 (89%) control participants had ≥5 CHW interactions during the 30-day study period. All intervention (n=19, 100%) and control (n=26, 93%) participants who completed trial activities indicated their CHW interactions were \"very satisfying.\" In the full sample (N=56), fewer participants in the intervention group were readmitted 30 days after hospital discharge compared to the control group (n=3, 12% vs n=8, 26%; P=.12). Both arms had similar rates of missed clinic appointments and emergency department visits.
CONCLUSIONS: This pilot trial of a digitally-enabled CHW intervention for HF demonstrated feasibility, acceptability, and a clinically relevant reduction in 30-day readmissions among participants who received the intervention. Additional investigation is needed in a larger trial to determine the effect of this intervention on HF home management and clinical outcomes.
BACKGROUND: Clinicaltrials.gov NCT05130008; https://clinicaltrials.gov/study/NCT05130008.
UNASSIGNED: RR2-10.2196/55687.

BACKGROUND: Liver transplantation (LT) is indicated in patients with severe acute or chronic liver failure for which no other therapy is available. With the increasing number of LTs in recent years, liver centers worldwide must manage their patients according to their clinical situation and the expected waiting time for transplantation. The LT clinic at the Centre hospitalier de l\'Université de Montréal (CHUM) is developing a new health care model across the entire continuum of pre-, peri-, and posttransplant care that features patient monitoring by an interdisciplinary team, including an accompanying patient; a digital platform to host a clinical plan; a learning program; and data collection from connected objects.
OBJECTIVE: This study aims to (1) evaluate the outcomes following the implementation of a patient platform with connected devices and an accompanying patient, (2) identify implementation barriers and facilitators, (3) describe service outcomes in terms of health outcomes and the rates and nature of contact with the accompanying patient, (4) describe patient outcomes, and (5) assess the intervention\'s cost-effectiveness.
METHODS: Six types of participants will be included in the study: (1) patients who received transplants and reached 1 year after transplantation before September 2023 (historical cohort or control group), (2) patients who will receive an LT between December 2023 and November 2024 (prospective cohort/intervention group), (3) relatives of those patients, (4) accompanying patients who have received an LT and are interested in supporting patients who will receive an LT, (5) health care professionals, and (6) decision makers. To describe the study sample and collect data to achieve all the objectives, a series of validated questionnaires, accompanying patient logbooks, transcripts of interviews and focus groups, and clinical indicators will be collected throughout the study.
RESULTS: In total, 5 (steering, education, clinical-technological, nurse prescription, and accompanying patient) working committees have been established for the study. Recruitment of patients is expected to start in November 2023. All questionnaires and technological platforms have been prepared, and the clinicians, stakeholders, and accompanying patient personnel have been recruited.
CONCLUSIONS: The implementation of this model in the trajectory of LT recipients at the CHUM may allow for better monitoring and health of patients undergoing transplantation, ultimately reducing the average length of hospital stay and promoting better use of medical resources. In the event of positive results, this model could be transposed to all transplant units at the CHUM and across Quebec (potentially affecting 888 patients per year) but could also be applied more widely to the monitoring of patients with other chronic diseases. The lessons learned from this project will be shared with decision makers and will serve as a model for other initiatives involving accompanying patients, connected objects, or digital platforms.
UNASSIGNED: PRR1-10.2196/54440.

BACKGROUND: Interventions focused on remote monitoring and social needs care have shown promise in improving clinical outcomes for patients with heart failure (HF). However, patient willingness to use technology as well as concerns about access in underresourced settings have limited digital platform implementation and adoption. There is little research in HF populations examining the effect of a combined digital and social needs care intervention that could enhance patient engagement in digital platform use while closing gaps in care related to social determinants of health. Here, we describe the protocol for a clinical trial of a digitally enabled community health worker intervention designed for patients with HF.
OBJECTIVE: This study aims to describe the protocol for a randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of an intervention that combines remote monitoring with a digital platform and community health worker (CHW) social needs care for patients with HF who are transitioning from hospital to home. Given the elevated morbidity and mortality, identifying comprehensive and patient-centered interventions at the time of hospital care transitions that can improve clinical outcomes, impact cost, and augment the quality of care for this cohort is a priority.
METHODS: This trial randomized adult inpatient participants (n=50) with a diagnosis of HF receiving care at a single academic health care institution to the 30-day intervention (digital platform+CHW pairing+usual care) or the 30-day control (CHW pairing+usual care) arms. All study participants completed baseline questionnaires and 30-day exit interviews and questionnaires. The primary outcomes will be acceptability, feasibility, and preliminary effectiveness.
RESULTS: This clinical trial opened for enrollment in September 2022 and was completed in June 2023. Initial results are expected to be published in the spring of 2024, and analysis is currently underway. Feasibility outcome measures will include the use rates of the biometric sensor (average hours per day), the digital blood pressure monitor (average times per day), the weight scale (average times per day), and the completion of the symptoms questionnaire (average times per day). The acceptability outcome will be measured by the patients\' response to the truthfulness of the statement that they would be willing to use the digital platform in the future (response options: very true, somewhat true, or not true). Preliminary effectiveness will be measured by tracking 30-day clinical outcomes (hospital readmissions, emergency room visits, and missed primary care and cardiology appointments).
CONCLUSIONS: The results of this investigation are expected to contribute to our understanding of the use of digital interventions and the implementation of supportive home-based social needs care to enhance engagement and the potential effectiveness of clinically focused digital platforms. These results may inform the construction of a future multi-institutional trial designed to test the true effectiveness of this intervention in HF.
BACKGROUND: ClinicalTrials.gov NCT05130008; https://clinicaltrials.gov/study/NCT05130008.
UNASSIGNED: DERR1-10.2196/55687.

UNASSIGNED: The transition to parenthood is a period of major stressors and increased risk of anxiety for all parents. Though rates of perinatal anxiety are similar among women (4%-25%) and men (3%-25%), perinatal anxiety research on nonbirthing partners remains limited.
UNASSIGNED: We aimed to examine whether demographic characteristics or digital perinatal support preferences differed among nonbirthing partners with compared to without self-reported high parenthood-related anxiety.
UNASSIGNED: In this large cross-sectional study of nonbirthing partners using a digital perinatal health platform during their partner\'s pregnancy, users reported their parenthood-related anxiety through a 5-item Likert scale in response to the prompt \"On a scale of 1=None to 5=Extremely, how anxious are you feeling about parenthood?\" High parenthood-related anxiety was defined as reporting being very or extremely anxious about parenthood. During the onboarding survey, in response to the question \"Which areas are you most interested in receiving support in?\" users selected as many support interests as they desired from a list of options. Chi-square and Fisher exact tests were used to compare demographic characteristics and support interests of nonbirthing partners with low versus high parenthood anxiety. Logistic regression models estimated the odds ratios (ORs), with 95% CIs, of high parenthood-related anxiety with each user characteristic or digital support interest.
UNASSIGNED: Among 2756 nonbirthing partners enrolled in the digital platform during their partner\'s pregnancy, 2483 (90.1%) were men, 1668 (71.9%) were first-time parents, 1159 (42.1%) were non-Hispanic White, and 1652 (50.9%) endorsed an annual household income of >US $100,000. Overall, 2505 (91.9%) reported some amount of parenthood-related anxiety, and 437 (15.9%) had high parenthood-related anxiety. High parenthood-related anxiety was more common among non-White nonbirthing partners: compared to those who identified as non-Hispanic White, those who identified as Asian, Black, or Hispanic had 2.39 (95% CI 1.85-3.08), 2.01 (95% CI 1.20-3.23), and 1.68 (95% CI 1.15-2.41) times the odds of high parenthood-related anxiety, respectively. Lower household income was associated with increased odds of reporting high parenthood anxiety, with the greatest effect among those with annual incomes of US $100,000 (OR 2.13, 95% CI 1.32-3.34). In general, nonbirthing partners were interested in receiving digital support during their partner\'s pregnancy, but those with high parenthood-related anxiety were more likely to desire digital support for all support interests compared to those without high parenthood anxiety. Those with high parenthood-related anxiety had more than 2 times higher odds of requesting digital education about their emotional health compared to those without high parenthood-related anxiety (OR 2.06, 95% CI 1.67-2.55).
UNASSIGNED: These findings demonstrate the need for perinatal anxiety-related support for all nonbirthing partners and identify nonbirthing partners\' demographic characteristics that increase the odds of endorsing high parenthood-related anxiety. Additionally, these findings suggest that most nonbirthing partners using a digital health platform with high parenthood-related anxiety desire to receive perinatal mental health support.

UNASSIGNED: Social media is a crucial source of health information for many parents due to its integration into modern life, raising critical concerns for public health. Parents use various social media platforms to find health information for their children, with most information created and shared by parents with no medical or health training. The extent to which parents seek health information from social media before and after a consultation and their motivations for doing so remain underresearched.
UNASSIGNED: This study aimed to investigate Australian parents\' use of social media for health information for their children, aged between 6 months and 5 years, before and after consulting with health care professionals.
UNASSIGNED: A representative cross-sectional survey of 1000 Australian parents with children aged 6 months to 5 years was conducted between November and December 2021. Data were cleaned and analyzed using IBM SPSS software. The primary outcomes were (1) parental motivation and prevalence of social media use for health information and (2) parental motivation for using social media before and after a consultation with their child\'s health care professional.
UNASSIGNED: Of the 1000 parents surveyed, 82.2% (n=822) reported using social media for health information for their child. Parents were more likely to consult social media before and after a health consultation if they were aged 30-39 or ≥50 years and born in Australia. Parents with higher levels of education were less likely to consult social media. Parents were motivated to seek health information before a consultation for a variety of reasons, including exchanging opinions and experiences (639/767, 83.3%), having information that is available 24/7 (622/767, 81.1%), receiving emotional support (599/767, 78.1%), having previous positive experiences (597/767, 77.8%), and having friends and family that use social media for health information (577/767, 75.2%). Parents sought information after a consultation to connect with parents with similar experiences (546/794, 68.8%), seek a second opinion (505/794, 63.6%), fact-check information provided by their health care professional (483/794, 60.8%), and look for other treatment options (353/794, 44.5%).
UNASSIGNED: Using social media for child health information is part of the modern parenting experience. It can be challenging to discern the quality of health information on social media, leaving parents open to incorrect information and misinformation. Although access to immediate social support is a welcomed feature of social media, receiving incorrect health information can have unwanted consequences for the child, family, health provider, and wider community. The upskilling of parental health literacy to navigate the unique health literacy challenges that social media brings, alongside the creation and delivery of accessible, evidence-based information in varying formats, is urgently required. The provision of this information is the responsibility of every level of the health system, not just the treating health care professional.

BACKGROUND: Heart failure (HF) is one of the leading causes of hospital admissions. Clinical (eg, complex comorbidities and low ejection fraction) and social needs factors (eg, access to transportation, food security, and housing security) have both contributed to hospitalizations, emphasizing the importance of increased clinical and social needs support at home. Digital platforms designed for remote monitoring of HF can improve clinical outcomes, but their effectiveness has been limited by patient barriers such as lack of familiarity with technology and unmet social care needs. To address these barriers, this study explored combining a digital platform with community health worker (CHW) social needs care for patients with HF.
OBJECTIVE: We aim to determine the feasibility and acceptability of an intervention combining digital platform use and CHW social needs care for patients with HF.
METHODS: Adults (aged ≥18 years) with HF receiving care at a single health care institution and with a history of hospital admission in the previous 12 months were enrolled in a single-arm pilot study from July to November 2021 (N=14). The 30-day intervention used a digital platform within a mobile app that included symptom questionnaire and educational videos connected to a biometric sensor (tracking heart rate, oxygenation, and steps taken), a digital weight scale, and a digital blood pressure monitor. All patients were paired with a CHW who had access to the digital platform data. A CHW provided routine phone calls to patients throughout the study period to discuss their biometric data and to address barriers to any social needs. Feasibility outcomes were patient use of the platform and engagement with the CHW. The acceptability outcome was patient willingness to use the intervention again.
RESULTS: Participants (N=14) were 67.7 (SD 11.7) years old; 8 (57.1%) were women, and 7 (50%) were insured by Medicare. Participants wore the sensor for 82.2% (n=24.66) of study days with an average of 13.5 (SD 2.1) hours per day. Participants used the digital blood pressure monitor and digital weight scale for an average of 1.2 (SD 0.17) times per day and 1.1 (SD 0.12) times per day, respectively. All participants completed the symptom questionnaire on at least 71% (n=21.3) of study days; 11 (78.6%) participants had ≥3 CHW interactions, and 11 (78.6%) indicated that if given the opportunity, they would use the platform again in the future. Exit interviews found that despite some platform \"glitches,\" participants generally found the remote monitoring platform to be \"helpful\" and \"motivating.\"
CONCLUSIONS: A novel intervention combining a digital platform with CHW social needs care for patients with HF was feasible and acceptable. The majority of participants were engaged throughout the study and indicated their willingness to use the intervention again. A future clinical trial is needed to determine the effectiveness of this intervention.

BACKGROUND: Since the COVID-19 pandemic, there has been a boost in the digital transformation of the human society, where wearable devices such as a smartwatch can already measure vital signs in a continuous and naturalistic way; however, the security and privacy of personal data is a challenge to expanding the use of these data by health professionals in clinical follow-up for decision-making. Similar to the European General Data Protection Regulation, in Brazil, the Lei Geral de Proteção de Dados established rules and guidelines for the processing of personal data, including those used for patient care, such as those captured by smartwatches. Thus, in any telemonitoring scenario, there is a need to comply with rules and regulations, making this issue a challenge to overcome.
OBJECTIVE: This study aimed to build a digital solution model for capturing data from wearable devices and making them available in a safe and agile manner for clinical and research use, following current laws.
METHODS: A functional model was built following the Brazilian Lei Geral de Proteção de Dados (2018), where data captured by smartwatches can be transmitted anonymously over the Internet of Things and be identified later within the hospital. A total of 80 volunteers were selected for a 24-week follow-up clinical trial divided into 2 groups, one group with a previous diagnosis of COVID-19 and a control group without a previous diagnosis of COVID-19, to measure the synchronization rate of the platform with the devices and the accuracy and precision of the smartwatch in out-of-hospital conditions to simulate remote monitoring at home.
RESULTS: In a 35-week clinical trial, >11.2 million records were collected with no system downtime; 66% of continuous beats per minute were synchronized within 24 hours (79% within 2 days and 91% within a week). In the limit of agreement analysis, the mean differences in oxygen saturation, diastolic blood pressure, systolic blood pressure, and heart rate were -1.280% (SD 5.679%), -1.399 (SD 19.112) mm Hg, -1.536 (SD 24.244) mm Hg, and 0.566 (SD 3.114) beats per minute, respectively. Furthermore, there was no difference in the 2 study groups in terms of data analysis (neither using the smartwatch nor the gold-standard devices), but it is worth mentioning that all volunteers in the COVID-19 group were already cured of the infection and were highly functional in their daily work life.
CONCLUSIONS: On the basis of the results obtained, considering the validation conditions of accuracy and precision and simulating an extrahospital use environment, the functional model built in this study is capable of capturing data from the smartwatch and anonymously providing it to health care services, where they can be treated according to the legislation and be used to support clinical decisions during remote monitoring.

BACKGROUND: Major depressive disorder (MDD) is a leading cause of disability worldwide. Management of chronic conditions such as MDD can be improved by enhanced patient engagement, measurement-based care (MBC), and shared decision-making (SDM). A user-centered design approach can improve the understanding of the patient journey and care team workflows and thus aid the development of digital health care innovations optimized for the needs of patients living with MDD and their primary care teams.
OBJECTIVE: This study aims to use qualitative research methods for the user-centered design of a digitally enabled MDD care platform, PathwayPlatform, intended to enhance patient engagement, MBC, and SDM.
METHODS: Insights were gathered through 2 stages of qualitative interviews by a study team with expertise in qualitative research and user-centered design methods. Thematic analysis was used to generate an overarching understanding of a set of shared experiences, thoughts, or behaviors across a broad qualitative data set, including transcripts of interviews, to allow both inductive and deductive insights to emerge. Thematic analysis of interviews was supported by Dedoose (SocioCultural Research Consultants, LLC), a qualitative data analysis software tool that enables systematized coding. Findings and insights were presented based on code frequency, salience, and relevance to the research project.
RESULTS: In stage 1, interviews were conducted with 20 patients living with MDD and 15 health care providers from September 2018 to January 2019 to understand the experiences with and perceptions about the initial functionality of the Pathway app while also exploring the perceptions about potential additional features and functionality. Feedback about care team workflows and treatment approaches was collected in stage-2 interviews with 36 health care providers at 8 primary care sites. Inductive and deductive thematic analyses revealed several themes related to app functionality, patient-provider engagement, workflow integration, and patient education. Both patients and their care teams perceived the remote tracking of patient-reported outcomes via digital tools to be clinically useful and reliable and to promote MBC and SDM. However, there was emphasis on the need to enhance the flow of real-time data shared with the care team, improve trend visualizations, and integrate the data within the existing clinical workflow and educational programs for patients and their care teams. User feedback was incorporated into the iterative development of the Pathway app.
CONCLUSIONS: Ongoing communication with patients living with MDD and their care teams provided an opportunity for user-centric developmental iterations of the Pathway Platform. Key insights led to further development of the patient-facing and care team-facing visit preparation features, collaborative goal-setting and goal-tracking features, patient-reported outcome summaries, and trend visualizations. The result is an enhanced digital platform with the potential to improve treatment outcomes and provide patients living with MDD additional support throughout their treatment journey.