Remote Short Sessions of Heart Rate Variability Biofeedback Monitored With Wearable Technology: Open-Label Prospective Feasibility Study.

BACKGROUND: Heart rate variability (HRV) biofeedback is often performed with structured education, laboratory-based assessments, and practice sessions. It has been shown to improve psychological and physiological function across populations. However, a means to remotely use and monitor this approach would allow for wider use of this technique. Advancements in wearable and digital technology present an opportunity for the widespread application of this approach. OBJECTIVE: The primary aim of the study was to determine the feasibility of fully remote, self-administered short sessions of HRV-directed biofeedback in a diverse population of health care workers (HCWs). The secondary aim was to determine whether a fully remote, HRV-directed biofeedback intervention significantly alters longitudinal HRV over the intervention period, as monitored by wearable devices. The tertiary aim was to estimate the impact of this intervention on metrics of psychological well-being. METHODS: To determine whether remotely implemented short sessions of HRV biofeedback can improve autonomic metrics and psychological well-being, we enrolled HCWs across 7 hospitals in New York City in the United States. They downloaded our study app, watched brief educational videos about HRV biofeedback, and used a well-studied HRV biofeedback program remotely through their smartphone. HRV biofeedback sessions were used for 5 minutes per day for 5 weeks. HCWs were then followed for 12 weeks after the intervention period. Psychological measures were obtained over the study period, and they wore an Apple Watch for at least 7 weeks to monitor the circadian features of HRV. RESULTS: In total, 127 HCWs were enrolled in the study. Overall, only 21 (16.5%) were at least 50% compliant with the HRV biofeedback intervention, representing a small portion of the total sample. This demonstrates that this study design does not feasibly result in adequate rates of compliance with the intervention. Numerical improvement in psychological metrics was observed over the 17-week study period, although it did not reach statistical significance (all P>.05). Using a mixed effect cosinor model, the mean midline-estimating statistic of rhythm (MESOR) of the circadian pattern of the SD of the interbeat interval of normal sinus beats (SDNN), an HRV metric, was observed to increase over the first 4 weeks of the biofeedback intervention in HCWs who were at least 50% compliant. CONCLUSIONS: In conclusion, we found that using brief remote HRV biofeedback sessions and monitoring its physiological effect using wearable devices, in the manner that the study was conducted, was not feasible. This is considering the low compliance rates with the study intervention. We found that remote short sessions of HRV biofeedback demonstrate potential promise in improving autonomic nervous function and warrant further study. Wearable devices can monitor the physiological effects of psychological interventions.

The Bitemporal Lens Model-toward a holistic approach to chronic disease prevention with digital biomarkers.

Objectives: We introduce the Bitemporal Lens Model, a comprehensive methodology for chronic disease prevention using digital biomarkers. Materials and Methods: The Bitemporal Lens Model integrates the change-point model, focusing on critical disease-specific parameters, and the recurrent-pattern model, emphasizing lifestyle and behavioral patterns, for early risk identification. Results: By incorporating both the change-point and recurrent-pattern models, the Bitemporal Lens Model offers a comprehensive approach to preventive healthcare, enabling a more nuanced understanding of individual health trajectories, demonstrated through its application in cardiovascular disease prevention. Discussion: We explore the benefits of the Bitemporal Lens Model, highlighting its capacity for personalized risk assessment through the integration of two distinct lenses. We also acknowledge challenges associated with handling intricate data across dual temporal dimensions, maintaining data integrity, and addressing ethical concerns pertaining to privacy and data protection. Conclusion: The Bitemporal Lens Model presents a novel approach to enhancing preventive healthcare effectiveness.

Development of Therapeutic Alliance and Social Presence in a Digital Intervention for Pediatric Concussion: Qualitative Exploratory Study.

BACKGROUND: Despite the promising benefits of self-guided digital interventions for adolescents recovering from concussion, attrition rates for such interventions are high. Evidence suggests that adults can develop therapeutic alliance with self-guided digital interventions, which is in turn associated with intervention engagement. However, no research has examined whether adolescents develop therapeutic alliance with self-guided digital interventions and what factors are important to its development. Additionally, social presence-the extent to which digital encounters feel like they are occurring in person-may be another relevant factor to understanding the nature of the connection between adolescents and a self-guided digital intervention, though this has yet to be explored. OBJECTIVE: This qualitative study explored the extent to which adolescents recovering from concussion developed therapeutic alliance and social presence during their use of a self-guided digital mindfulness-based intervention. Additionally, this study aimed to determine factors important to adolescents' development of therapeutic alliance and social presence with the intervention. METHODS: Adolescents aged between 12 and 17.99 years who sustained a concussion were recruited from 2 sites: a pediatric emergency department up to 48 hours after a concussion and a tertiary care clinic over 1 month following a concussion to capture adolescents who had both acute and persisting symptoms after concussion. Participants (N=10) completed a 4-week mindfulness-based intervention delivered through a smartphone app. Within the app, participants listened to audio recordings of mindfulness guides (voice actors) narrating psychoeducation and mindfulness practices. At 4 weeks, participants completed questionnaires and a semistructured interview exploring their experience of therapeutic alliance and social presence with the mindfulness guides in the intervention. RESULTS: Themes identified within the qualitative results revealed that participants developed therapeutic alliance and social presence by "developing a genuine connection" with their mindfulness guides and "sensing real people." Particularly important to the development of therapeutic alliance and social presence were the mindfulness guides' "personal backgrounds and voices," such that participants felt more connected to the guides by knowing information about them and through the guides' calm tone of voice in audio recordings. Quantitative findings supported qualitative results; participants' average score for therapeutic alliance was far above the scale midpoint, while the mixed results for social presence measures aligned with qualitative findings that participants felt that the mindfulness guides seemed real but not quite as real as an in-person connection would. CONCLUSIONS: Our data suggest that adolescents can develop therapeutic alliance and social presence when using digital interventions with no direct human contact. Adolescents' development of therapeutic alliance and social presence with self-guided digital interventions can be bolstered by increasing human-like qualities (eg, real voices) within interventions. Maximizing therapeutic alliance and social presence may be a promising way to reduce attrition in self-guided digital interventions while providing accessible treatment.

Characteristics of Users of a Digital Hypnotherapy Intervention for Hot Flashes: Retrospective Study.

BACKGROUND: Hot flashes are associated with a lower quality of life and sleep disturbances. Given the many consequences of hot flashes, it is important to find treatments to reduce them. Hypnotherapy, the use of hypnosis for a medical disorder or concern, has been shown in clinical trials to be effective in reducing hot flashes, but it is not routinely used in clinical practice. One solution to close this implementation gap is to administer hypnotherapy for hot flashes via a smartphone app. Evia is a smartphone app that delivers hypnotherapy for hot flashes. Evia has made hypnotherapy more widely accessible for women who are experiencing hot flashes; however, the app has yet to undergo empirical testing. Additionally, research on user characteristics is lacking. OBJECTIVE: This study aims to (1) determine the average age, stage of menopause, and length of menopause symptoms for users of the Evia app; (2) determine the characteristics of hot flashes and night sweats for users of the Evia app; (3) determine the self-reported sleep quality of users of the Evia app; (4) determine the self-reported mental health of users of the Evia app; and (5) determine the relationship between hot flash frequency and anxiety and depression for users of the Evia app. METHODS: This study analyzed data collected from participants who have downloaded the Evia app. Data were collected at 1 time point from a self-report questionnaire that assessed the demographic and clinical characteristics of users. The questionnaire was given to users when they downloaded the Evia app. Users of the Evia app fill out a questionnaire upon enrolling in the program and prior to beginning the intervention. This included 9764 users. RESULTS: Results showed that the mean age of users was 49.31 years. A total of 41.6% (1942/4665) of users reported experiencing 5 or more hot flashes per day, while 51.2% (1473/2877) of users reported having difficulty falling asleep each night and 47.7% (1253/2626) of users reported their sleep quality to be terrible. In addition, 38.4% (1104/2877) of users reported that they often feel anxious or depressed. There was a small, significant, and negative correlation between hot flash frequency and self-report frequency of anxiety and depression (r=-0.09). CONCLUSIONS: This study showed that the average age of app users is in line with the median age of natural menopause. A large percentage of users reported experiencing 5 or more hot flashes per day, reported difficulties with sleep, and reported experiencing depression and anxiety. These findings are in line with previous studies that assessed hot flash frequency and the consequences of hot flashes. This was the first study to report on the characteristics of users of the Evia app. Results will be used to optimize the hypnotherapy program delivered via the Evia app.

Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocol.

Introduction: The use of new technologies presents an opportunity to promote physical activity, especially among young people with type 1 diabetes (T1DM), who tend to be less active compared to their healthy counterparts. The aim of this study is to investigate the impact of a personalized resistance exercise program, facilitated by the Diactive-1 App, on insulin requirements among children and adolescents diagnosed with T1DM. Methods and analysis: A minimum of 52 children and adolescents aged 8-18 years, who were diagnosed with T1DM at least 6 months ago, will be randomly assigned to either a group engaging in an individualized resistance exercise program at least 3 times per week over a 24-week period or a waiting-list control group. The primary outcome will be the daily insulin dose requirement. The secondary outcomes will include glycemic control, cardiometabolic profile, body composition, vascular function, physical fitness, 24-hour movement behaviors, diet, and psychological parameters. The usability of the app will also be assessed. Ethics and dissemination: Ethical approval to conduct this study has been granted by the University Hospital of Navarra Research Board (PI_2020/140). Parents or legal guardians of minors participating in the study will provide written consent, while children and adolescents will sign an assent form to indicate their voluntary agreement. The trial's main findings will be shared through conference presentations, peer-reviewed publications, and communication directly with participating families. This study aims to offer valuable insights into the holistic management of children and adolescents with T1DM by utilizing personalized exercise interventions through an mHealth system. Trial registration: NCT06048757.

An Intelligent Customer-Driven Digital Solution to Improve Perioperative Health Outcomes Among Children Undergoing Circumcision and Their Parents: Development and Evaluation.

BACKGROUND: Circumcision as a common elective pediatric surgery worldwide is a stressful and anxiety-inducing experience for parents and children. Although current perioperative interventions proved effective, such as reducing preoperative anxiety, there are limited holistic solutions using mobile apps. OBJECTIVE: This paper aims to describe the development and primary evaluation of an intelligent customer-driven smartphone-based app program (ICory-Circumcision) to enhance health outcomes among children undergoing circumcision and their family caregivers. METHODS: Based on the review of the literature and previous studies, Bandura's self-efficacy theory was adopted as the conceptual framework. A multidisciplinary team was built to identify the content and develop the apps. Semistructured interviews were conducted to evaluate the ICory-Circumcision. RESULTS: The ICory-Circumcision study was carried out from March 2019 to January 2020 and comprised 2 mobile apps, BuddyCare app and Triumf Health mobile game app. The former provides a day-by-day perioperative guide for parents whose children are undergoing circumcision, while the latter provides emotional support and distraction to children. In total, 6 participants were recruited to use the apps and interviewed to evaluate the program. In total, 4 main categories and 10 subcategories were generated from content analysis. CONCLUSIONS: ICory-Circumcision seemed to lean toward being useful. Revisions to ICory-Circumcision are necessary to enhance its contents and features before advancing to the randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT04174404; https://clinicaltrials.gov/ct2/show/NCT04174404.

mHealth Gratitude Exercise Mindfulness App for Resiliency Among Neonatal Intensive Care Unit Staff: Three-Arm Pretest-Posttest Interventional Study.

BACKGROUND: Health care is highly complex and can be both emotionally and physically challenging. This can lead health care workers to develop compassion fatigue and burnout (BO), which can negatively affect their well-being and patient care. Higher levels of resilience can potentially prevent compassion fatigue and BO. Strategies that enhance resilience include gratitude, exercise, and mindfulness. OBJECTIVE: The purpose of this study was to determine if a 3-week daily resiliency practice, prompted via a gratitude, exercise, and mindfulness smartphone app, impacted the professional quality of life, physical activity, and happiness level of health care workers in a newborn intensive care unit setting. METHODS: In total, 65 participants from a level III newborn intensive care unit at a regional hospital in the western United States completed this study. The Professional Quality of Life Scale, Physical Activity Vital Sign, and Subjective Happiness Score instruments were used to evaluate the effects of the mobile health (mHealth) intervention. Further, 2-tailed dependent paired t tests were used to evaluate participant pre- and postintervention instrument scores. Multiple imputation was used to predict scores of participants who practiced an intervention but did not complete the 3 instruments post intervention. RESULTS: Dependent t tests using the original data showed that participants, as a whole, significantly improved in BO (t35=2.30, P=.03), secondary trauma stress (STS; t35=2.11, P=.04), and happiness (t35=-3.72, P<.001) scores. Compassion satisfaction (CS; t35=-1.94, P=.06) and exercise (t35=-1.71, P=.10) were trending toward, but did not reach, significance. Using the original data, only the gratitude intervention group experienced significant improvements (CS, BO, and happiness), likely due to the higher number of participants in this group. Analysis using imputed data showed that participants, as a whole, had significant improvements in all areas: CS (t64=-4.08, P<.001), BO (t64=3.39, P=.001), STS (t64=4.08, P<.001), exercise (t64=-3.19, P=.002), and happiness (t64=-3.99, P<.001). Looking at the intervention groups separately using imputed data, the gratitude group had significant improvements in CS, BO, STS, and happiness; the exercise group had significant improvements in STS and exercise; and the mindfulness group had significant improvements in CS and happiness. CONCLUSIONS: Phone app delivery of resilience-enhancing interventions is a potentially effective intervention model for health care workers. Potential barriers to mHealth strategies are the technical issues that can occur with this type of intervention. Additional longitudinal and experimental studies with larger sample sizes need to be completed to better evaluate this modality.

Mobile Mindfulness Meditation for Cancer-Related Anxiety and Neuropathy: Protocol for a Randomized Controlled Trial.

BACKGROUND: Anxiety- and cancer-related neuropathy are two persistent effects related to treatment for cancer. Mindfulness meditation has been used with substantial impact as a nonpharmacologic intervention to mitigate side and late effects of treatment. Mobile apps are ubiquitous for most of the general population, yet have a particular relevance for cancer survivors, given that physical and geographic limitations can be present. OBJECTIVE: This study aims to describe an ongoing trial of the Mindfulness Coach mobile app for cancer survivors. METHODS: In this randomized waitlist controlled trial, cancer survivors experiencing anxiety- or cancer-related neuropathy (200 for neuropathy and 200 for anxiety) and who had finished primary cancer treatment were invited to participate. Data were collected at 3 time points regardless of randomization condition: baseline, 8 weeks, and 16 weeks. Both face-to-face and web-based recruitment strategies were used. The trial was opened for 2 separate primary outcomes (anxiety- or cancer-related neuropathy). The goal was not to compare these groups but to compare treatment and waitlist groups for each condition. In addition to evaluating the impact of mobile mindfulness on reported anxiety- or cancer-related neuropathy, other pain, fatigue, trauma, sleep, and satisfaction with the Mindfulness Coach app will also be assessed. RESULTS: Outcomes of the study are expected in early 2024. CONCLUSIONS: Mindfulness meditation has become widely practiced, and the use of mobile technology has become ubiquitous. Finding ways to deliver mindfulness meditation to people who have been treated for cancer allows for the intervention to be accessible to a larger number of survivors. The results of this intervention could have implications for further understanding the impact of mindfulness meditation on 2 persistent side and late effects of treatment of cancer, namely anxiety- and cancer-related neuropathy. TRIAL REGISTRATION: ClinicalTrials.gov NCT03581357; https://ClinicalTrials.gov/study/NCT03581357. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47745.

Support for Chronic Pain Management for Breast Cancer Survivors Through Novel Digital Health Ecosystems: Pilot Usability Study of the PainRELife Mobile App.

BACKGROUND: Chronic pain is one of the most common and critical long-term effects of breast cancer. Digital health technologies enhance the management of chronic pain by monitoring physical and psychological health status and supporting pain self-management and patient treatment decisions throughout the clinical pathway. OBJECTIVE: This pilot study aims to evaluate patients' experiences, including usability, with a novel digital integrated health ecosystem for chronic pain named PainRELife. The sample included patients with breast cancer during survivorship. The PainRELife ecosystem comprises a cloud technology platform interconnected with electronic health records and patients' devices to gather integrated health care data. METHODS: We enrolled 25 patients with breast cancer (mean age 47.12 years) experiencing pain. They were instructed to use the PainRELife mobile app for 3 months consecutively. The Mobile Application Rating Scale (MARS) was used to evaluate usability. Furthermore, pain self-efficacy and participation in treatment decisions were evaluated. The study received ethical approval (R1597/21-IEO 1701) from the Ethical Committee of the European Institute of Oncology. RESULTS: The MARS subscale scores were medium to high (range: 3.31-4.18), and the total app quality score was 3.90. Patients with breast cancer reported reduced pain intensity at 3 months, from a mean of 5 at T0 to a mean of 3.72 at T2 (P=.04). The total number of times the app was accessed was positively correlated with pain intensity at 3 months (P=.03). The engagement (P=.03), information (P=.04), and subjective quality (P=.007) subscales were positively correlated with shared decision-making. Furthermore, participants with a lower pain self-efficacy at T2 (mean 40.83) used the mobile app more than participants with a higher pain self-efficacy (mean 48.46; P=.057). CONCLUSIONS: The data collected in this study highlight that digital health technologies, when developed using a patient-driven approach, might be valuable tools for increasing participation in clinical care by patients with breast cancer, permitting them to achieve a series of key clinical outcomes and improving quality of life. Digital integrated health ecosystems might be important tools for improving ongoing monitoring of physical status, psychological burden, and socioeconomic issues during the cancer survivorship trajectory. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/41216.

Feasibility and Acceptability of a Mobile Technology Intervention to Support Postabortion Care After Surgical Abortion (the FACTS Study Phase 3): Mixed Methods Prospective Pilot Study.

BACKGROUND: In Canada, 1 in 3 women and people of gestational age undergo an abortion in their lifetime. Despite the liberal legal context, barriers continue to exist for women and people who can become pregnant to access this service. OBJECTIVE: This study aims to (1) conduct a pilot study to demonstrate the feasibility and acceptability of myPostCare to support follow-up care after a procedural abortion; (2) use the findings to understand whether myPostCare has the potential to improve contraceptive behavior and knowledge, emotional well-being, and sexual health knowledge; and (3) develop a better understanding of how innovative mobile solutions can support integrative health programs in British Columbia with the goal of expanding to other sites across Canada. METHODS: People of gestational age (aged 14-45 y) who underwent a procedural abortion were recruited from 2 urban abortion facilities in British Columbia. The participants completed a baseline quantitative survey and were provided access to myPostCare for up to 30 days. A follow-up quantitative survey was sent via email on day 30. Qualitative interviews were conducted to explore user satisfaction and usability of myPostCare. Responses to the survey questions were summarized using descriptive statistics, and the system usability scale (SUS) was scored according to the instructions. A secure analytics platform was implemented to obtain data on the overall use of the website by users. Qualitative analysis was conducted with NVivo using a thematic analysis approach. This study was approved by the Women's and Children's Research Ethics Board. RESULTS: Overall, 62 participants were recruited (average age 30 y); 40% (25/62) of the participants completed the exit surveys, and 24% (6/25) consented to participate in the semistructured interviews; 40 participants had undergone an immediate postabortion intrauterine device (IUD) insertion, and 22 did not have an IUD inserted. Participants were satisfied with myPostCare. The SUS average score was 81.5 (SD 9.7; median 82.5, IQR 77.5-87.5), indicating high usability of the tool. Overall, 88% (22/25) of the participants changed their contraceptive method to an IUD. Web-based analytics demonstrated that there were 61 unique visitors to the site, and the top pages visited were Postprocedure Care, Emotional Well-Being, and Contraception Explorer. The longest time spent on the website was 56 minutes. The overall email open rate was 80%, with a click rate of 36%. CONCLUSIONS: This study demonstrates that communities and individuals are important collaborators in developing a mobile innovation that facilitates access to high-quality patient-centered abortion care. Through the cocreation process, a digital platform such as myPostCare highlighted a gap in abortion care in Canada, particularly around follow-up support after a procedural abortion.

Attributes of Provider Referrals for Digital Mental Health Applications in an Integrated Health System, 2019-2021.

OBJECTIVE: This article describes trends and attributes associated with digital mental health application (DMHA) referrals from December 2019 through December 2021. METHODS: In total, 43,842 DMHA referrals for 25,213 unique patients were extracted from the electronic health record of a large, diverse, integrated health system. DMHAs were aggregated by type (cognitive-behavioral therapy [CBT] or mindfulness and meditation [MM]). Monthly referral patterns were described and categorized into mutually exclusive clusters (MM, CBT, or MM and CBT). Multinomial logistic regression and post hoc predicted probabilities were used to profile patient, clinical, and encounter attributes among referral clusters. RESULTS: DMHA referrals increased, reached equilibrium, and then began to decline over the 25-month observation period. Compared with the referral cluster average, MM-alone referrals were more likely to occur for patients who were ages ≥65, who were Hispanic or Asian, whose reason for visit concerned mental health, and who had a primary diagnosis of other anxiety disorders. CBT-alone referrals were more likely to occur for patients with a primary diagnosis of depression and less likely to occur for Hispanic patients. Combined MM and CBT referrals were more likely to occur for patients who were ages 18-30, whose reason for visit was "other," and who had a primary diagnosis of depression and were less likely to occur for Hispanic patients and those ages ≥65. CONCLUSIONS: Although this study demonstrates readiness to integrate DMHA referral into clinical workflows, observed variations in attributes of referral clusters support the need to further investigate provider decision making and whether referral patterns are optimal and sustainable.

Effectiveness of m-health-based core strengthening exercise and health education for public safety workers with chronic non-specific low back pain: study protocol for a superiority randomized controlled trial (SAFEBACK).

BACKGROUND: Low back pain (LBP) is the leading cause of years lived with disability worldwide. Public safety workers are highly exposed to physically demanding activities and inappropriate postures, increasing the risk of experiencing LBP. Smartphone app-based self-managed interventions may be an alternative for chronic non-specific LBP (CNSLBP) treatment. This study aims to evaluate the effectiveness of a smartphone app-based self-managed exercise program plus health education, compared to a health education program alone, on neuromuscular and perceptual outcomes in police officers and firefighters with CNSLBP. METHODS: This is a parallel, two-armed, blinded evaluator randomized clinical trial. Police officers and firefighters (from public safety institutions in the Rio Grande do Sul state, Brazil) will be randomly assigned to a m-health self-managed exercise program (twice a week) plus health education or health education alone. Self-management exercise program components are mobility and core resistance exercises, available on the app. Follow-ups will be conducted post-treatment (8 weeks) and 16 weeks after randomization. The co-primary outcomes will be pain intensity and disability post-treatment (8 weeks). Secondary outcomes will be biopsychosocial factors related to CNSLBP. DISCUSSION: We hypothesize that the effects of a smartphone app-based self-managed exercise program on co-primary and secondary outcomes will be superior, compared to the health education only in public safety workers with CNSLBP. TRIAL REGISTRATION: The study was prospectively registered at ClinicalTrials.gov (NCT05481996. Registered on August 01, 2022).

Healthcare Professionals' Perspectives on Improving Dietary Supplement Documentation in the Electronic Medical Record: Current Challenges and Opportunities to Enhance Quality of Care and Patient Safety.

Background: Around half the US population uses dietary supplements (DS), and concomitant use with medications is common. Many DS include bioactive substances that can interact with medications; therefore, accurate tracking is critical for patient safety. Unfortunately, documentation of patients' DS use is often missing or incomplete in the electronic medical record (EMR), leaving patients susceptible to potential adverse events. Novel approaches to assist healthcare professionals (HCPs) in capturing patients' DS use are needed. Objective: To assess HCPs' perspectives on challenges and facilitators of DS documentation in the EMR and their opinions on a proposed mHealth application (app) to aid in DS capture. Methods: HCPs, recruited from professional networks, largely in North Carolina, using purposive sampling, took part in semi-structured interviews. We inquired about HCPs' experiences with DS documentation in the EMR and their opinions about our proposed mHealth app. Interviews were recorded, transcribed, and coded. Thematic analysis included deductive codes based on the interview guide, and inductive codes that emerged during transcript review. Results: HCPs (N = 30) included 60% females, mean age 46 ± 10; 70% White. Pharmacists (20%), nurses (17%), and physicians (17%) were the most represented professions. Years in practice ranged from 3-35 years. Most HCPs were concerned about DS safety and potential supplement-drug interactions, and cited several barriers to accurate EMR DS documentation including time constraints, database inconsistencies, and poor patient-HCP communication about DS. HCPs' views on our proposed mHealth app were generally positive. They expressed that our proposed mHealth app could streamline documentation processes and enhance patient-provider communication. HCPs expressed desire for a high-quality mHealth app that includes access to evidence-based DS information, integrates with the EMR, and does not increase time burdens. Conclusion: HCPs believe documentation of patients' DS use is important but not accurately captured in the EMR. Support was expressed for our proposed barcode-scanning DS mHealth app.

Evaluating the Impact of an App-Delivered Mindfulness Meditation Program to Reduce Stress and Anxiety During Pregnancy: Pilot Longitudinal Study.

BACKGROUND: Stress and anxiety during pregnancy are extremely prevalent and are associated with numerous poor outcomes, among the most serious of which are increased rates of preterm birth and low birth weight infants. Research supports that while in-person mindfulness training is effective in reducing pregnancy stress and anxiety, there are barriers limiting accessibility. OBJECTIVE: The aim of this paper is to determine if mindfulness meditation training with the Headspace app is effective for stress and anxiety reduction during pregnancy. METHODS: A longitudinal, single-arm trial was implemented with 20 pregnant women who were instructed to practice meditation via the Headspace app twice per day during the month-long trial. Validated scales were used to measure participant's levels of stress and anxiety pre- and postintervention. Physiological measures reflective of stress (heart rate variability and sleep) were collected via the Oura Ring. RESULTS: Statistically significant reductions were found in self-reported levels of stress (P=.005), anxiety (P=.01), and pregnancy anxiety (P<.0001). Hierarchical linear modeling revealed a statistically significant reduction in the physiological data reflective of stress in 1 of 6 heart rate variability metrics, the low-frequency power band, which decreased by 13% (P=.006). A total of 65% of study participants (n=13) reported their sleep improved during the trial, and 95% (n=19) stated that learning mindfulness helped with other aspects of their lives. Participant retention was 100%, with 65% of participants (n=13) completing about two-thirds of the intervention, and 50% of participants (n=10) completing ≥95%. CONCLUSIONS: This study found evidence to support the Headspace app as an effective intervention to aid in stress and anxiety reduction during pregnancy.

Digital Health Equity and Tailored Health Care Service for People With Disability: User-Centered Design and Usability Study.

BACKGROUND: As digital health services advance, digital health equity has become a significant concern. However, people with disability and older adults still face health management limitations, particularly in the COVID-19 pandemic. An essential area of investigation is proposing a patient-centered design strategy that uses patient-generated health data (PGHD) to facilitate optimal communication with caregivers and health care service providers. OBJECTIVE: This study aims to conceptualize, develop, and validate a digitally integrated health care service platform for people with disability, caregivers, and health care professionals, using Internet of Things devices and PGHD to contribute to improving digital health equity. METHODS: The methodology consists of 5 stages. First, a collaborative review of the previous app, Daily Healthcare 1.0, was conducted with individuals with disabilities, caregivers, and health care professionals. Secondly, user needs were identified via personas, scenarios, and user interface sketches to shape a user-centered service design. The third stage created an enhanced app that integrated these specifications. In the fourth stage, heuristic evaluations by clinical and app experts paved the way for Daily Healthcare 2.0, now featuring Internet of Things device integration. Conclusively, in the fifth stage, an extensive 2-month usability evaluation was executed with user groups comprising individuals with disabilities using the app and their caregivers. RESULTS: Among the participants, "disability welfare information and related institutional linkage" was the highest priority. Three of the 14 user interface sketches the participants created were related to "providing educational content." The 11 heuristic evaluation experts identified "focusing on a single task" as a crucial issue and advocated redesigning the home menu to simplify it and integrate detailed menus. Subsequently, the app Daily Healthcare 2.0 was developed, incorporating wearable devices for collecting PGHD and connecting individuals with disabilities, caregivers, and health care professionals. After the 2-month usability evaluation with 27 participants, all participants showed an increase in eHealth literacy, particularly those who used the caregiver app. Relatively older users demonstrated improved scores in health IT usability and smartphone self-efficacy. All users' satisfaction and willingness to recommend increased, although their willingness to pay decreased. CONCLUSIONS: In this study, we underscore the significance of incorporating the distinct needs of individuals with disabilities, caregivers, and health care professionals from the design phase of a digital health care service, highlighting its potential to advance digital health equity. Our findings also elucidate the potential benefits of fostering partnerships between health consumers and providers, thereby attenuating the vulnerability of marginalized groups, even amid crises such as the COVID-19 pandemic. Emphasizing this imperative, we advocate for sustained endeavors to bolster the digital literacy of individuals with disabilities and champion collaborative cocreation, aiming to uphold the collective ethos of health and digital health equity.

Health Outcomes Following Engagement With a Digital Health Tool Among People With Prediabetes and Type 2 Diabetes: Prospective Evaluation Study.

BACKGROUND: Diabetes is a worldwide chronic condition causing morbidity and mortality, with a growing economic burden on health care systems. Complications from poorly controlled diabetes are associated with increased socioeconomic costs and reduced quality of life. Smartphones have become an influential platform, providing feasible tools such as health apps to deliver tailored support to enhance the ability of patients with diabetes for self-management. Gro Health is a National Health Service division X-certified digital health tool used to deliver educational and monitoring support to facilitate the development of skills and practices for maintaining good health. OBJECTIVE: This study aims to assess self-reported outcomes of the Gro Health app among users with diabetes and prediabetes and identify the factors that determine engagement with the digital health tool. METHODS: This was a service evaluation of self-reported data collected prospectively by the developers of the Gro Health app. The EQ-5D questionnaire is a standardized tool used to measure health status for clinical and economic appraisal. Gro Health users completed the EQ-5D at baseline and 6 months after using the app. Users provided informed consent for the use of their anonymized data for research purposes. EQ-5D index scores and visual analogue scale (VAS) scores were calculated at baseline and 6 months for individuals with prediabetes and type 2 diabetes. Descriptive statistics and multiple-regression models were used to assess changes in the outcome measures and determine factors that affected engagement with the digital tool. RESULTS: A total of 84% (1767/2114) of Gro Health participants completed EQ-5D at baseline and 6 months. EQ-5D index scores are average values that reflect people's preferences about their health state (1=full health and 0=moribund). There was a significant and clinically meaningful increase in mean EQ-5D index scores among app users between baseline (0.746, SD 0.23) and follow-up (0.792, SD 0.22; P<.001). The greatest change was observed in the mean VAS score, with a percentage change of 18.3% improvement (61.7, SD 18.1 at baseline; 73.0, SD 18.8 at follow-up; P<.001). Baseline EQ-5D index scores, age, and completion of educational modules were associated with significant changes in the follow-up EQ-5D index scores, with baseline EQ-5D index scores, race and ethnicity, and completion of educational modules being significantly associated with app engagement (P<.001). CONCLUSIONS: This study provides evidence of a significant positive effect on self-reported quality of life among people living with type 2 diabetes engaging with a digital health intervention. The improvements, as demonstrated by the EQ-5D questionnaire, are facilitated through access to education and monitoring support tools within the app. This provides an opportunity for health care professionals to incorporate National Health Service-certified digital tools, such as Gro Health, as part of the holistic management of people living with diabetes.

Usability and Quality Evaluation of the "E- Midwife" Mobile Application for Nurse-Midwives in Obstetric Complications: A Randomized Controlled Trial.

Background: Obstetric complications are illnesses that develop during childbirth. Smartphones, which facilitate the use of prompt features in the early diagnosis of challenges and quick delivery of respectful maternity care, are one of the most recent advances in health technology. The key objective of this project is to evaluate the usability and quality of the "E-Midwife" mobile application for nurse-midwives, which focuses on obstetric complications. Methods: This study is a component of a randomized controlled trial on nurse-midwives. This project followed a four-step approach: content development phase, app design phase, app development phase, and usability testing phase. The app was developed using extensive flowcharts, a definition of the navigational framework, a structured database, and user-friendly software. 140 out of the 196 nurse-midwives were allocated to the intervention (n=70) and control group (n=70), using random allocation. The intervention group used the application for 8 weeks. Usability and quality of the application were assessed using the system usability scale and the mobile application rating scale, respectively. SPSS statistical software, version 17, was used to analyze the dat. Results: The overall score of the usability testing of E-Midwife was 82.75±0.68. The total mean score of quality was 3.77±0.86. Therefore, it was shown to have good usability and quality. Conclusion: The E-midwife mobile application has a high usability and quality which makes its usage effective and efficient. It is recommended that these similar mobile apps should be used along with other educational methods for educating the nurse-midwives.Trial Registration Number: CTRI/2022/03/040857.

Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial.

BACKGROUND: Increasing access to nonpharmacological interventions to manage pain and posttraumatic stress disorder (PTSD) is essential for veterans. Complementary and integrative health (CIH) interventions can help individuals manage symptom burden with enhanced accessibility via remotely delivered health care. Mission Reconnect (MR) is a partnered, self-directed intervention that remotely teaches CIH skills. OBJECTIVE: The purpose of this paper is to describe the recruitment, onboarding phase, and attrition of a fully remote randomized controlled trial (RCT) assessing the efficacy of a self-directed mobile and web-based intervention for veterans with comorbid chronic pain and PTSD and their partners. METHODS: A total of 364 veteran-partner dyads were recruited to participate in a mixed methods multisite waitlist control RCT. Qualitative attrition interviews were conducted with 10 veterans with chronic pain and PTSD, and their self-elected partners (eg, spouse) who consented but did not begin the program. RESULTS: At the point of completing onboarding and being randomized to the 2 treatment arms, of the 364 recruited dyads, 97 (26.6%) failed to complete onboarding activities. Reported reasons for failure to complete onboarding include loss of self-elected partner buy-in (n=8, 8%), difficulties with using remote data collection methods and interventions (n=30, 31%), and adverse health experiences unrelated to study activities (n=23, 24%). Enrolled veterans presented at baseline with significant PTSD symptom burden and moderate-to-severe pain severity, and represented a geographically and demographically diverse population. Attrition interviews (n=10) indicated that misunderstanding MR including the intent of the intervention or mistaking the surveys as the actual intervention was a reason for not completing the MR registration process. Another barrier to MR registration was that interviewees described the mailed study information and registration packets as too confusing and excessive. Competing personal circumstances including health concerns that required attention interfered with MR registration. Common reasons for attrition following successful MR registration included partner withdrawal, adverse health issues, and technological challenges relating to the MR and electronic data collection platform (Qualtrics). Participant recommendations for reducing attrition included switching to digital forms to reduce participant burden and increasing human interaction throughout the registration and baseline data collection processes. CONCLUSIONS: Challenges, solutions, and lessons learned for study recruitment and intervention delivery inform best practices of delivering remote self-directed CIH interventions when addressing the unique needs of this medically complex population. Successful recruitment and enrollment of veterans with chronic pain and PTSD, and their partners, to remote CIH programs and research studies requires future examination of demographic and symptom-associated access barriers. Accommodating the unique needs of this medically complex population is essential for improving the effectiveness of CIH programs. Disseminating lessons learned and improving access to remotely delivered research studies and CIH programs is paramount in the post-COVID-19 climate. TRIAL REGISTRATION: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772.

App-based meditation habits maintain reductions in depression symptoms among autistic adults.

LAY ABSTRACT: Existing research has identified an increased risk of depression among autistic adults, which can negatively impact their adaptive functioning abilities and socioeconomic outcomes. Mobile app-based meditation is a feasible, accessible, and effective self-care solution for depression among neurotypical adults, but there is limited evidence for the long-term benefits of app-based meditation among autistic adults. Habits are a key behavioral strategy for maintaining behavior change, and anchoring is one effective habit formation intervention that has yet to be tested among autistic adults. This study demonstrates that it is both feasible and effective to integrate the anchoring habit formation strategy into an app-based meditation intervention for establishing meditation habits among autistic adults. In addition, the study shows that app-based meditation habits were successful at maintaining reductions in depressive symptoms over 6 months. These results demonstrate the power of anchoring-based habit formation interventions for establishing healthy habits among autistic adults, which offers a promising behavioral intervention technique for establishing other healthy habits among autistic adults. The study also shows that app-based meditation habits are an effective long-term self-care solution for managing depressive symptoms among autistic adults that should be used by mental health providers and policymakers. Future research should test this combined anchoring and app-based meditation intervention technique among larger samples of autistic adults and over longer durations to better understand the mechanisms underlying the success of this intervention.

Self-Administered Gentle Yoga and Yoga Breathing Intervention Improves Burden and Stress Biomarkers in Caregivers of Persons Living with Dementia.

Family caregivers of adults with Alzheimer's disease and related dementias (ADRD) are the fastest growing group of informal healthcare providers in the United States. These individuals experience high levels of stress and physical and psychosocial symptoms related to their caregiving role. We provided 20 ADRD caregivers (≥ 55 years of age) with training and access to a mobile health app for at-home practice of gentle yoga and yoga breathing exercises. Here, we report secondary outcomes, including changes in caregiver physical and mental function, burden, fatigue, sleep, and biological stress markers (salivary cortisol and 1,5-anhydroglucitol [1,5-AG] assays) from Baseline (Week 1) to Study End (Week 12). Self-reported questionnaire data were collected online via the Research Electronic Data Capture system, and biomarker data were collected via saliva samples. Results supported indications for slight improvement in outcomes of caregiving burden among ADRD caregivers using the gentle yoga and yoga breathing app. Furthermore, slight improvements in mental health were observed; the greatest gains were made by those reporting higher burden and having family members with more severe dementias. Findings indicate that those experiencing the greatest improvement in caregiver burden scores spent the most time doing gentle yoga and yoga breathing exercises. Salivary stress biomarkers moved in a favorable direction (decreased cortisol; increased 1,5-AG) among caregivers practicing the exercises most often. This is among the first studies of gentle yoga and yoga breathing exercises for relieving ADRD caregiver burden and the first we are aware of to incorporate stress biomarker measurement.