UNASSIGNED: Prior research has not assessed the value of remote patient monitoring (RPM) systems for patients undergoing anticoagulation therapy after cardiac surgery. This study aims to assess whether the clinical follow-up through RPM yields comparable outcomes with the standard protocol.
UNASSIGNED: A crossover trial assigned participants to SOC-RPM or RPM-SOC, starting with the standard of care (SOC) for the first 6 months after surgery and using RPM for the following 6 months, or vice-versa, respectively. During RPM, patients used the Coaguchek© to accurately measure International Normalized Ratio values and a mobile text-based chatbot to report PROs and adjust the therapeutic dosage. The study assessed patients\' and clinicians\' experience with RPM and compared direct costs.
UNASSIGNED: Twenty-seven patients participated. The median time in therapeutic range (TTR) levels during RPM were 72.2% and 50.6% for the SOC-RPM and RPM-SOC arms, respectively, and during SOC, they were 49.4% and 58.4% for SOC-RPM and RPM-SOC arms, respectively. Patients and the clinical team reported high trust and satisfaction with the proposed digital service. Statistically significant differences were only found in the cost of RPM in the RPM-SOC, which was higher than SOC in the SOC-RPM arm.
UNASSIGNED: Portable coagulometers and chatbots can enhance the remote management of patients undergoing anticoagulation therapy, improving patient experience. This presents a promising alternative to the current standard procedure. The results of this study seem to suggest that RPM may have a higher value when initiated after a SOC period rather than starting RPM immediately after surgery.Trial registration: ClinicalTrials.gov NCT06423521.

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BACKGROUND: Breath testing for small intestinal bacterial overgrowth (SIBO) is typically performed using clinic-based equipment or single-use test kits.
OBJECTIVE: This study aimed to evaluate the utility of a portable, point-of-care breath analysis device (AIRE®, FoodMarble) in patients suspected to have SIBO. A technical assessment including a comparison to existing mail-in kits was first performed. Then, postprandial breath hydrogen levels of patients before and after antibiotic treatment were gathered and compared to levels seen in a healthy cohort.
METHODS: For the comparison, 50 patients suspected of having SIBO were provided with an AIRE device and performed concurrent LHBTs at-home with a mail-in breath test kit. For the postprandial analysis, twenty-four patients with chronic GI symptoms measured their postprandial hydrogen for 7 days prior to antibiotic treatment and for 7 days after treatment. 10 healthy controls also measured their postprandial hydrogen for 7 days.
RESULTS: Substantial agreement was demonstrated between AIRE and the mail-in kits for the performance of lactulose hydrogen breath tests (κ = 0.8). Prior to treatment, patients had significantly greater daily postprandial hydrogen than healthy controls (p < 0.001). The mean postprandial hydrogen of patients reduced significantly after treatment (p < 0.001).
CONCLUSIONS: Measuring postprandial hydrogen shows potential as a means of differentiating patients with chronic GI symptoms from healthy controls and may be useful in monitoring patients before, during, and after treatment. Future studies could help determine if pre-treatment breath gas levels are predictive of response to antibiotic treatment.

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that severely impacts affected persons\' speech and motor functions, yet early detection and tracking of disease progression remain challenging. The current gold standard for monitoring ALS progression, the ALS functional rating scale - revised (ALSFRS-R), is based on subjective ratings of symptom severity, and may not capture subtle but clinically meaningful changes due to a lack of granularity. Multimodal speech measures which can be automatically collected from patients in a remote fashion allow us to bridge this gap because they are continuous-valued and therefore, potentially more granular at capturing disease progression. Here we investigate the responsiveness and sensitivity of multimodal speech measures in persons with ALS (pALS) collected via a remote patient monitoring platform in an effort to quantify how long it takes to detect a clinically-meaningful change associated with disease progression. We recorded audio and video from 278 participants and automatically extracted multimodal speech biomarkers (acoustic, orofacial, linguistic) from the data. We find that the timing alignment of pALS speech relative to a canonical elicitation of the same prompt and the number of words used to describe a picture are the most responsive measures at detecting such change in both pALS with bulbar (n = 36) and non-bulbar onset (n = 107). Interestingly, the responsiveness of these measures is stable even at small sample sizes. We further found that certain speech measures are sensitive enough to track bulbar decline even when there is no patient-reported clinical change, i.e. the ALSFRS-R speech score remains unchanged at 3 out of a total possible score of 4. The findings of this study have the potential to facilitate improved, accelerated and cost-effective clinical trials and care.

Body temperature must be monitored in patients receiving Hospital-at-Home (HaH) care for COVID-19 and other infectious diseases. Continuous temperature telemonitoring (CTT) detects fever and patient deterioration early, facilitating decision-making. We performed a validation clinical study assessing the safety, comfort, and impact on healthcare practice of Viture®, a CTT system, compared with a standard digital axillary thermometer in 208 patients with COVID-19 and other infectious diseases treated in HaH at the Navarra University Hospital (HUN). Overall, 3258 pairs of measurements showed a clinical bias of -0.02 °C with limits of agreement of -0.96/+0.92 °C, a 95% acceptance rate, and a mean absolute deviation of 0.36 (SD 0.30) °C. Viture® detected 3 times more febrile episodes and revealed fever in 50% more patients compared with spot measurements. Febrile episodes were detected 7.23 h (mean) earlier and modified the diagnostic and/or therapeutic approach in 43.2% of patients. Viture® was validated for use in a clinical setting and was more effective in detecting febrile episodes than conventional methods.

BACKGROUND: The Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study is a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes (T2D). The study aims to test the efficacy of a personalized behavioral approach for dietary management of moderately controlled T2D, versus a standardized behavioral intervention that uses one-size-fits-all dietary recommendations, versus a usual care control (UCC). The primary outcome will compare the impact of each intervention on the mean amplitude of glycemic excursions (MAGE).
METHODS: Eligible participants are between 21 and 80 years of age diagnosed with moderately controlled T2D (HbA1c: 6.0 to 8.0%) and managed on lifestyle alone or lifestyle plus metformin. Participants must be willing and able to attend virtual counseling sessions and log meals into a dietary tracking smartphone application (DayTwo), and wear a continuous glucose monitor (CGM) for up to 12 days. Participants are randomized with equal allocation (n = 255, n = 85 per arm) to one of three arms: (1) Personalized, (2) Standardized, or (3) UCC. Measurements occur at 0 (baseline), 3, and 6 months. All participants receive isocaloric energy and macronutrient targets to meet Mediterranean diet guidelines, in addition to 14 intervention contacts over 6 months (4 weekly then 10 biweekly) to cover diabetes self-management education. The first 4 UCC intervention contacts are delivered via synchronous videoconferences followed by educational video links. Participants in Standardized receive the same educational content as those in the UCC arm, following the same schedule. However, all intervention contacts are conducted via synchronous videoconferences, paired with Social Cognitive Theory (SCT)-based behavioral counseling, plus dietary self-monitoring of planned meals using a mobile app that provides real-time feedback on calories and macronutrients. Participants in the Personalized arm receive all elements of the Standardized intervention, in addition to real-time feedback on predicted post-prandial glycemic response (PPGR) to meals and snacks logged into the mobile app.
CONCLUSIONS: The DiaTeleMed Study aims to address an important gap in the current landscape of precision nutrition by determining the contributions of behavioral counseling and personalized nutrition recommendations on glycemic control in individuals with T2D. The fully remote methodology of the study allows for scalability and innovative delivery of personalized dietary recommendations at a population level.
BACKGROUND: ClinicalTrials.gov NCT05046886. Registered on September 16, 2021.

UNASSIGNED: User engagement with remote blood pressure monitoring during pregnancy is critical to optimize the associated benefits of blood pressure control and early detection of hypertensive disorders of pregnancy. In our study population of pregnant individuals, we found that connected blood pressure cuffs, which automatically sync measures to a monitoring platform or health record, increase engagement (2.13 [95% CI 1.36-3.35] times more measures per day) with remote blood pressure monitoring compared to unconnected cuffs that require manual entry of measures.

In this study, we describe the responsiveness of timing-related measures extracted from read speech in persons with ALS (pALS) collected via a remote patient monitoring platform in an effort to quantify how long it takes to detect a clinically-meaningful change associated with disease progression. We found that the timing alignment of pALS speech relative to a canonical elicitation of the same prompt is the most responsive measure, of the ones considered in this study, at detecting such change in both pALS with bulbar (n = 35) and non-bulbar onset (n = 94). We further evaluated the sensitivity of speech metrics in tracking disease progression in pALS while their ALSFRS-R speech score remained unchanged at 3 out of a total possible score of 4. We observed that timing-related speech metrics showed significant longitudinal changes even after accounting for learning effects. The findings of this study have the potential to inform disease prognosis and functional outcomes of clinical trials.

UNASSIGNED: Unmanaged hypertension in pregnancy is the second most common cause of direct maternal death and disproportionately affects women in rural areas. While telehealth technologies have worked to reduce barriers to healthcare, lack of internet access has created new challenges. Cellular-enabled remote patient monitoring devices provide an alternative option for those without access to internet.
UNASSIGNED: This study aimed to assess maternal and neonatal clinical outcomes and patient acceptability of an integrated model of cellular-enabled remote patient monitoring devices for blood pressure supported by a 24/7 nurse call center.
UNASSIGNED: In a mixed-methods study, 20 women with hypertension during pregnancy were given a cellular-enabled BodyTrace blood pressure cuff. Participants\' blood pressures were continuously monitored by a nurse call center. Participants completed a baseline survey, post-survey, and semi-structured interview after 8 weeks of device use.
UNASSIGNED: Participants reported a significant decrease in perceived stress after device use (P = .0004), high satisfaction with device usability (mean = 78.38, SD = 13.68), and high intention to continue device use (mean = 9.05, SD = 1.96). Relatively low hospitalization and emergency department rates was observed (mean = 0.35, SD = 0.59; mean = 0.75, SD = 0.91). Participant-perceived benefits of device use included convenience, perceived better care owing to increased monitoring, and patient empowerment. Perceived disadvantages included higher blood pressure readings compared to clinical readings and excessive calls from call center.
UNASSIGNED: Remote patient monitoring for women whose pregnancies are complicated by hypertension can reduce barriers and improve health outcomes for women living in rural and low-health-resource areas.

BACKGROUND: Community health center (CHC) patients experience a disproportionately high prevalence of chronic conditions and barriers to accessing technologies that might support the management of these conditions. One such technology includes tools used for remote patient monitoring (RPM), the use of which surged during the COVID-19 pandemic.
OBJECTIVE: The aim of this study was to assess how a CHC implemented an RPM program during the COVID-19 pandemic.
METHODS: This retrospective case study used a mixed methods explanatory sequential design to evaluate a CHC\'s implementation of a suite of RPM tools during the COVID-19 pandemic. Analyses used electronic health record-extracted health outcomes data and semistructured interviews with the CHC\'s staff and patients participating in the RPM program.
RESULTS: The CHC enrolled 147 patients in a hypertension RPM program. After 6 months of RPM use, mean systolic blood pressure (BP) was 13.4 mm Hg lower and mean diastolic BP 6.4 mm Hg lower, corresponding with an increase in hypertension control (BP<140/90 mm Hg) from 33.3% of patients to 81.5%. Considerable effort was dedicated to standing up the program, reinforced by organizational prioritization of chronic disease management, and by a clinician who championed program implementation. Noted barriers to implementation of the RPM program were limited initial training, lack of sustained support, and complexities related to the RPM device technology.
CONCLUSIONS: While RPM technology holds promise for addressing chronic disease management, successful RPM program requires substantial investment in implementation support and technical assistance.