Bluetooth-enabled Blood Pressure Research Articles

Abstract P316: Beyond the Cuff: Revolutionizing Hypertension Care through Human-Centered Design and Tech-Driven Solutions in an Urban Community Health Center

Community Health Centers serve populations burdened with cardiovascular disease due to social determinants of health, necessitating innovative solutions in resource-limited environments. Wi-Fi/Bluetooth-enabled home blood pressure monitors have emerged as clinical tools for diagnosing, monitoring, and managing hypertension. The real time data enables timely interventions by care teams of patients being monitored. A multifaceted approach beyond clinic settings, supported by digital tools, can help reduce healthcare costs by preventing avoidable emergency room visits. We posited that implementing a self-monitored blood pressure (SMBP) program, supplemented by holistic, human-centered patient coaching and feedback, in a community health center setting would enhance patient engagement, medication adherence, and hypertension control. We designed and piloted a small SMBP program using Bluetooth-enabled blood pressure devices, targeting adult patients with documented uncontrolled blood pressure seen in our health centers in a 6- month window. This was further augmented by a holistic, human-centered individual and group-level coaching session. Patients enrolled in the SMBP program received comprehensive education on hypertension, including medication management and lifestyle changes, as well as data-driven feedback on their blood pressure profiles during virtual group and individual outreach sessions. The program's goals were to increase patient engagement in their care, adherence to interventions, leading to better blood pressure control. Results were significant: 22 of 32 participants graduated, achieving improved blood pressure control with medication and lifestyle changes. Average reductions of 17 mmHg in systolic and 6 mmHg in diastolic blood pressure were noted after being in the program for an average of three months. Among the graduates, 50% required medication intensification, and 60% adopted lifestyle changes, indicating the program's effectiveness. Our pilot affirmed the efficacy of utilizing digital solutions and integrated strategies to improve hypertension control and empower patients to make timely changes with data feedback. The key findings from our pilot led to the expansion of the SMBP program to serve a larger cohort of patients in our clinic. This underscores the critical role of patient engagement, technology integration, and an integrated approach to care in improving hypertension management, particularly in underserved communities.

Abstract 17939: Predictors of Time in Target Range in a Comprehensive Self-Measured Blood Pressure Program in a Socially and Economically Disadvantaged Primary Care Population

Introduction: The Community Practice Center (CPC) in North Philadelphia serves a community with significant socioeconomic barriers leading to inability to access care necessary for management of hypertension (HTN). Prior studies have shown the efficacy of SMBP programs in improving blood pressure (BP) control. Methods: All sequential patients presenting to the CPC with stage 2 HTN were screened for eligibility. Upon enrollment, patients received a Bluetooth-enabled BP cuff connected to a mobile health app and HTN education. Patients completed validated social and behavioral assessments including social determinants of health (SD)H) assessment via WellRx screen, depression screening (PHQ-9), and self-efficacy screening ( Self-Efficacy to Manage Chronic Disease Scale ). A behavior change plan was created using Brief Problem Solving Therapy based on the aforementioned assessments. Staff continuously monitored usage, BP, and provided individualized interventions. We conducted a cross-sectional quality improvement study using daily BP data from June 2022 - April 2023 to assess the correlation between baseline sociodemographic characteristics and Time in Target Range (TTR) through multivariable linear regression. We calculated TTR, defined as the percentage of time with systolic BP within 100-130 mmHg, through linear interpolation. Results: A total of 133 patients were enrolled in the program. We analyzed data from 78 patients with ≥3 days of readings (average 33; SD 49) and complete baseline characteristics (Table 1). Female sex and non-smoking status were associated with TTR, while diabetes, positive depression screening, positive SDOH screening, and self-efficacy were not (Table 2). Conclusions: In a socioeconomically disadvantaged population participating in a comprehensive SMBP program, depression, SDOH, and self-efficacy screening at time of enrollment did not predict TTR. Participation in a SMBP program may be valuable in these populations.

Exploring the Acceptability and Feasibility of Remote Blood Pressure Measurements and Cognition Assessments Among Participants Recruited From a Safety-Net Emergency Department (Reach Out Cognition): Nonrandomized Mobile Health Trial.

Hypertension is a prevalent cardiovascular risk factor disproportionately affecting Black Americans, who also experience a higher incidence of Alzheimer disease and Alzheimer disease-related dementias. Monitoring blood pressure (BP) and cognition may be important strategies in reducing these disparities. The objective of the Reach Out Cognition study was to explore the feasibility and acceptability of remote cognitive and BP assessments in a predominantly Black, low-income population. Reach Out was a randomized, controlled, mobile health-based clinical trial to reduce BP among patients with hypertension at an emergency department in a safety-net hospital (ie, a US hospital in which 25% of the patients are Medicaid recipients). Upon conclusion of Reach Out, participants were given the option of continuing into an extension phase, Reach Out Cognition, that included Bluetooth-enabled BP monitoring and digital cognitive assessments for 6 months. Digital cognitive assessments were text message-linked online surveys of the Self-Administered Gerocognitive Exam and Quality of Life in Neurological Disorders scale. BP assessments were measured with Bluetooth-enabled BP cuffs paired with an app and the data were manually sent to the research team. Outcomes were feasibility (ie, enrollment and 3- and 6-month completion of digital cognitive and BP assessments) and acceptability of assessments using a 4-item validated survey, ranging from 1 (not acceptable) to 5 (completely acceptable). Of the 211 Reach Out participants, 107 (50.7%) consented and 71 (33.6%) completed enrollment in Reach Out Cognition. Participants had a mean age of 49.9 years; 70.4% were female and 57.8% identified as Black. Among the 71 participants, 51 (72%) completed cognitive assessments at 3 months and 34 (48%) completed these assessments at 6 months. BP assessments were completed by 37 (52%) and 20 (28%) of the 71 participants at 3 and 6 months, respectively. Participants were neutral on the acceptability of the digital cognitive assessments (mean 3.7) and Bluetooth self-measured BP (SMBP) monitoring (mean 3.9). Participants noted challenges syncing the BP cuff to the app, internet connection, and transmitting the data to the research team. Enrollment and assessment completion were low, while acceptability was moderate. Technological advances will eliminate some of the Bluetooth SMBP barriers and offer new strategies for cognitive assessments. Subsequent studies could benefit from offering more comprehensive support to overcome Bluetooth-related hurdles, such as personalized training materials, video conferencing, or in-person research team support. Alternatively, strategies that do not require pairing with an app and passive transmission of data could be considered. Overall, further research is warranted to optimize participant engagement and overcome technological challenges. ClinicalTrials.gov NCT03422718; https://clinicaltrials.gov/study/NCT03422718.

Abstract 139: Hypertension Control In The Afro-dpp Program, A Virtual Cardiometabolic Health Intervention Among African Immigrants

Background: Black people and immigrants in the US are disproportionately affected by poor cardiometabolic health. Aim: To test the effectiveness of a virtual, culturally tailored lifestyle intervention with remote blood pressure (BP) monitoring on BP control among African immigrants. Methods: In this pilot cluster-randomized trial (NCT05144737), two churches were randomly assigned to first intervention or delayed intervention groups. African immigrants aged 25-75 years with a smartphone and ≥ 2 of the following were enrolled: body-mass index (BMI) ≥ 25 kg/m 2 , HbA1c 5.7-6.5%, systolic BP (SBP) ≥ 140 mmHg or diastolic BP (DBP) ≥ 90 mmHg. Intervention involved lifestyle coaching using the diabetes prevention program curriculum, adapted to African immigrants, Bluetooth-enabled BP monitor synced to a mobile app (Sphygmo TM ), allowing for remote BP readings. The primary outcome was 6-month change in BP. Results: A total of 60 participants, 30 per site, were recruited; mean age 50.6(±11.9). At baseline, mean SBP was 144.5 mmHg in the first intervention group and 148.3 mmHg in the delayed intervention group. At 6 months, there was 11.32 mmHg SBP, 9.73 mmHg DBP reduction in the first intervention group and 9.31 mmHg SBP, 5.34 mmHg DBP reduction in the delayed intervention group ( Figure ); mean SBP reduction was 4.35 mm Hg greater in the first intervention group (95% CI, -13.56, 4.87). Additional BP control (< 130/80 mmHg) was achieved in 22% of participants in the first intervention group, and 10% in the delayed intervention group. Conclusions: Among African immigrants at risk for cardiovascular disease, a culturally tailored, lifestyle intervention led to BP reduction.

A remote hypertension management program clinical algorithm.

Hypertension is the leading risk factor for death, affecting over onebillion people worldwide, yet control rates are poor and stagnant. We developed a remote hypertension management program that leverages digitally transmitted home blood pressure (BP) measurements, algorithmic care pathways, and patient-navigator communications to aid patients in achieving guideline-directed BP goals. Patients with uncontrolled hypertension are identified through provider referrals and electronic health record screening aided by population health managers within the Mass General Brigham (MGB) health system. Non-licensed patient navigators supervised by pharmacists, nurse practitioners, and physicians engage and educate patients. Patients receive cellular or Bluetooth-enabled BP devices with which they monitor and transmit scheduled home BP readings. Evidence-based medication changes are made according to a custom hypertension algorithm approved within a collaborative drug therapy management (CDTM) agreement with MGBand implemented by pharmacists. Using patient-specific characteristics, we developed different pathways to optimize medication regimens. The renin-angiotensin-aldosterone system-blocker pathway prescribed ARBs/ACE inhibitors first for patients with diabetes, impaired renal function, and microalbuminuria; the standard pathway started patients on calcium channel blockers. Regimens were escalated frequently, adding thiazide-type diuretics, and including beta blockers and mineralocorticoid receptor antagonists if needed. We have developed an algorithmic approach for the remote management of hypertension with demonstrated success. A focus on algorithmic decision-making streamlines tasks and responsibilities, easing the potential for scalability of this model. As the backbone of our remote management program, this clinical algorithm can improve BP control and innovate the management of hypertension in large populations.

Sociodemographic Characteristics Predicting Digital Health Intervention Use After Acute Myocardial Infarction

Increasing evidence suggests that digital health interventions (DHIs) are an effective tool to reduce hospital readmissions by improving adherence to guideline-directed therapy. We investigated whether sociodemographic characteristics influence use of a DHI targeting 30-day readmission reduction after acute myocardial infarction (AMI). Covariates included age, sex, race, native versus loaner iPhone, access to a Bluetooth-enabled blood pressure monitor, and disease severity as marked by treatment with CABG. Age, sex, and race were not significantly associated with DHI use before or after covariate adjustment (fully adjusted OR 0.98 (95%CI: 0.95–1.01), 0.6 (95%CI: 0.29–1.25), and 1.22 (95% CI: 0.60–2.48), respectively). Being married was associated with high DHI use (OR 2.12; 95% CI 1.02–4.39). Our findings suggest that DHIs may have a role in achieving equity in cardiovascular health given similar use by age, sex, and race. The presence of a spouse, perhaps a proxy for enhanced caregiver support, may encourage DHI use.Graphical abstract Supplementary InformationThe online version contains supplementary material available at 10.1007/s12265-021-10098-9.

Technology-supported home monitoring in heart failure patients

Abstract Background Digital health promises to enhance the prevailing episodic models of chronic heart failure (HF) care. Purpose We aimed to test the hypothesis that digital home monitoring with centralised specialist support for remote management of HF and major vascular comorbidities is more effective in optimising medical therapy and improving patients' quality of life than digital home monitoring alone. Methods and results In a two-armed partially blinded parallel randomised controlled trial, seven sites in the United Kingdom recruited a total of 202 adults with HF (71.3 years SD 11.1; mean left ventricular ejection fraction 32.9% SD 15.4). Participants were selected for being at high risk of adverse outcomes or high potential to benefit from remote management. Participants in both study arms were given an internet-enabled tablet computer, Bluetooth-enabled blood pressure monitor and weighing scales for health monitoring. After a run-in period, participants randomized to intervention received additional regular feedback to support self-management and their primary care doctors received instructions on blood investigations and pharmacological treatment. The primary outcome was the use of recommended medical therapy, for chronic HF and major comorbidities, measured as a composite opportunity score. Co-primary outcome was change in physical score of Minnesota Living with Heart failure questionnaire. At the end of the trial, the weighted opportunity score was 0.54 (CI 95% 0.46, 0.62) in the control group and 0.61 (CI 95% 0.52, 0.70) in the intervention arm (p for mean difference=0.25). Physical well-being of participants did not differ significantly between the groups either (p=0.55). Conclusions Central provision of tailored specialist management in a multimorbid HF population was feasible. However, there was no strong evidence for improvement in use of evidence-based therapies nor health-related quality of life. Figure 1 Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): National Institute for Health Research (NIHR) Health Services Research and Delivery; NIHR Career Development Fellowship

Home monitoring with technology-supported management in chronic heart failure: a randomised trial

ObjectivesWe aimed to investigate whether digital home monitoring with centralised specialist support for remote management of heart failure (HF) is more effective in improving medical therapy and patients’ quality of...

Pharmacists interventions using Bluetooth technology and telehealth to improve blood pressure—A pilot study

ObjectivesTo assess patients’ knowledge of blood pressure (BP) and their comfort level with using technology, including a Bluetooth-enabled BP device and pharmacist telemonitoring. The secondary objective was to discover if pharmacist interventions improved BP readings. SettingThe study took place in Pharmacy Plus and the Family Medicine Department at the University of South Florida in Tampa, FL. Practice descriptionThe pharmacists within Pharmacy Plus and the Family Medicine Department are part of the interdisciplinary team providing care to patients and seeking to achieve optimal patient outcomes. Pharmacy Plus breaks away from the traditional behind-the-counter model using innovative technology to create a personalized experience for patients. Practice innovationDuring this pilot study, the patients received a Bluetooth-enabled BP monitor and were asked to obtain their BP readings at least once daily for 6 weeks. The patients’ electronic health records automatically captured the BP readings, which were reviewed by the study pharmacists. The patients had an appointment with the pharmacists once weekly via a telehealth platform through which they were counseled on their weekly average BP, BP goals, lifestyle modifications, and proper use of the devices. EvaluationThe patients completed a prestudy survey assessing their baseline knowledge of BP, comfort level when using technology, and ease in working with pharmacists. Reliability and satisfaction in using the BP device and telehealth communication with pharmacists were also assessed poststudy. ResultsTwelve patients enrolled, with 9 completing the study. There was a statistically significant increase in patients’ knowledge of BP and an improvement in the recommended lifestyle modifications. In addition, comfort level regarding communication with the pharmacist was statistically significantly improved. The patients responded positively to using the Bluetooth-enabled BP monitor and telehealth for receiving health care services. ConclusionUsing Bluetooth-enabled BP monitors that report results in real time into electronic health records, along with pharmacist interventions within a team-based care model, may result in improved BP control and patient outcomes.

The Use of Wireless, Smartphone App-Assisted Home Blood Pressure Monitoring Among Hypertensive Patients in Singapore: Pilot Randomized Controlled Trial.

BackgroundReliable home blood pressure monitoring (HBPM) is essential to effective hypertension management; however, manual recording is subject to underreporting and inaccuracies. Mobile health technologies hold great potential as HBPM tools, but the fidelity of a smartphone app in HBPM has not been adequately assessed.ObjectiveThe primary aim of the trial was to compare the fidelity of a smartphone app to that of a handwritten logbook in making HBPM data available to clinicians at follow-up visits. Fidelity was defined as the percentage of scheduled blood pressure (BP) recordings over a 3-week period that were properly recorded and reported to the clinic. The secondary aims were to investigate patient factors associated with HBPM fidelity and to explore the effect of time on the fidelity.MethodsA 2-arm, parallel, unblinded, randomized controlled pilot trial was conducted in a government polyclinic in Singapore. Hypertensive adults, aged 40 to 70 years, who were on antihypertensive medication and owned a smartphone were recruited and randomized by a computer-generated randomization schedule to 3 weeks of either semiautomated HBPM utilizing a Bluetooth-enabled BP monitor and a smartphone app or a fully manual process utilizing a conventional handwritten logbook. The primary outcome was home BP recording fidelity.ResultsOf the 80 patients randomized, 79 (smartphone app: 38 and logbook: 41) were included in the final analysis. Although fidelity was higher among the app users, it did not differ significantly between study arms (smartphone app: 66.7% and logbook: 52.4%; P=.21). Chinese and Indian ethnicities were associated with higher fidelity (absolute percent and 95% CI) by 35.6% (4.27 to 66.9) and 45.0% (8.69 to 81.3), respectively, in comparison with other ethnicities (P=.03); longer smartphone ownership increased fidelity on an average of 10.5% (0.83 to 20.2) per year (P=.03); the number of apps on the smartphone decreased fidelity at a rate of −0.32% (−0.58 to −0.05) per app (P=.02); years of hypertension morbidity increased fidelity at a rate of 1.56% (0.03 to 3.09) per year (P=.046); and the number of people working in the household decreased fidelity at a rate of −8.18% (−16.3 to −0.08) per additional working person (P=.048). The fidelity of the app was significantly higher in the first week (64.4%) than the second (55.1%, P=.001) and third (58.2%, P=.03) weeks of monitoring.ConclusionsAmid the increasing integration of health technologies into clinical practice, our study demonstrates the feasibility of smartphone app–assisted HBPM in hypertensive adults of Singapore. Our pilot study found no statistically significant difference in mean BP recording fidelity between a smartphone app and conventional handwritten logbook. However, the small sample size precludes definitive conclusions and highlights the need for a larger, adequately powered trial.Trial RegistrationClinicalTrials.gov NCT03209024; https://clinicaltrials.gov/ct2/show/NCT03209024 (Archived by WebCite at http://www.webcitation.org/78EVWBg0T)

Technical Guidance for Clinicians Interested in Partnering With Engineers in Mobile Health Development and Evaluation.

The explosion of mobile health (mHealth) interventions has prompted significant investment and exploration that has extended past industry into academia. Although research in this space is emerging, it focuses on the clinical and population level impact across different populations. To realize the full potential of mHealth, an intimate understanding of how mHealth is being used by patients and potential differences in usage between various demographic groups must also be prioritized. In this viewpoint, we use our experiences in building an mHealth intervention that incorporates an iOS app, Bluetooth-enabled blood pressure cuff, and Apple Watch to share knowledge on (1) how user interaction data can be tracked in the context of health care privacy laws, (2) what is required for effective, nuanced communication between clinicians and engineers to design mHealth interventions that are patient-centered and have high clinical impact, and (3) how to handle and set up a process to handle user interaction data efficiently.

Corrie Health Digital Platform for Self-Management in Secondary Prevention After Acute Myocardial Infarction.

Unplanned readmissions after hospitalization for acute myocardial infarction are among the leading causes of preventable morbidity, mortality, and healthcare costs. Digital health interventions could be an effective tool in promoting self-management, adherence to guideline-directed therapy, and cardiovascular risk reduction. A digital health intervention developed at Johns Hopkins-the Corrie Health Digital Platform (Corrie)-includes the first cardiology Apple CareKit smartphone application, which is paired with an Apple Watch and iHealth Bluetooth-enabled blood pressure cuff. Corrie targets: (1) self-management of cardiac medications, (2) self-tracking of vital signs, (3) education about cardiovascular disease through articles and animated videos, and (4) care coordination that includes outpatient follow-up appointments. The 3 phases of the MiCORE study (Myocardial infarction, Combined-device, Recovery Enhancement) include (1) the development of Corrie, (2) a pilot study to assess the usability and feasibility of Corrie, and (3) a prospective research study to primarily compare time to first readmission within 30 days postdischarge among patients with Corrie to patients in the historical standard of care comparison group. In Phase 2, the feasibility of deploying Corrie in an acute care setting was established among a sample of 60 patients with acute myocardial infarction. Phase 3 is ongoing and patients from 4 hospitals are being enrolled as early as possible during their hospital stay if they are 18 years or older, admitted with acute myocardial infarction (ST-segment-elevation myocardial infarction or type I non-ST-segment-elevation myocardial infarction), and own a smartphone. Patients are either being enrolled with their own personal devices or they are provided an iPhone and/or Apple Watch for the duration of the study. Phase 3 started in October 2017 and we aim to recruit 140 participants. This article will provide an in-depth understanding of the feasibility associated with implementing a digital health intervention in an acute care setting and the potential of Corrie as a self-management tool for acute myocardial infarction recovery.

Impact of a Culturally Tailored mHealth Medication Regimen Self-Management Program upon Blood Pressure among Hypertensive Hispanic Adults.

Background: Uncontrolled hypertension (HTN) and medication nonadherence are more prominent among Hispanics compared to non-Hispanic whites and African Americans. Advances in wireless health technology enable real-time monitoring of medication adherence (MA) and blood pressure (BP), facilitating timely patient–provider communication including tailored reinforcement/motivational feedback to patients and quicker titration changes by providers. The purpose of the current study was to conduct a 9-month smartphone-enabled efficacy trial addressing MA and BP control among Hispanic adults with uncontrolled HTN and poor MA. Methods: The research design was a 9-month, two-arm efficacy trial including an experimental (Smartphone Med Adherence Stops Hypertension, SMASH) group and an enhanced standard care (ESC) group. SMASH participants utilized a SMASH app which interfaced with a Bluetooth-enabled BP monitor for BP self-monitoring and an electronic medication tray. The ESC participants received text messages including links to PDFs and brief video clips containing healthy lifestyle tips for attention control. Results: Participants were 54 Hispanic adults (mean age: 46.5 years) with uncontrolled HTN. They were randomly assigned to either the SMASH (n = 26) or ESC group (n = 28). At baseline, no participants had controlled systolic BP (SBP). Baseline group averages for SBP between the SC and SMASH groups did not differ (150.7 and 152.3 mmHg, respectively; p = 0.53). At the 1, 3, 6, and 9-month time points, SBP averages were significantly lower in the SMASH versus SC groups (month 1: 125.3 vs. 140.6; month 3: 120.4 vs. 137.5, month 6: 121.2 vs. 145.7 mmHg; month 9: 121.8 vs. 145.7, respectively; all p-values <0.01). At months 3, 6, and 9 there was a significant difference between the percentage of participants meeting the 7th Joint National Committee cutoffs for SBP control in the SC and SMASH groups (month 3: 62.5 vs. 92.0%; month 6: 57.9 and 94.4%, month 9: 27.8 and 92.3%, respectively; all p-values ≤0.01). Average medical regimen adherence, as indicated by timestamped medication intake and BP monitoring for the SMASH group, ranged from 89.1 to 95.2% across the 9-month trial. Conclusion: Our findings indicate that our culturally tailored smartphone-enabled medical regimen self-management program may be an effective solution for the promotion of MA, resulting in statistically and clinically significant reductions in SBP among Hispanic adults with uncontrolled HTN.

Abstract 26: The Corrie Myocardial infarction, COmbined-device, Recovery Enhancement (MiCORE) Study: 30-Day Readmission Rates and Cost-Effectiveness of a Novel Digital Health Intervention for Acute Myocardial Infarction Patients

Purpose: Determine if acute myocardial infarction (AMI) patients using a novel digital health intervention, the Corrie Health Digital Platform (Corrie), have reduced 30-day hospital readmissions and related healthcare costs compared to a historical comparison group. Methods: Corrie is deployed to patients admitted to Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Massachusetts General Hospital, and Reading Hospital for an AMI (STEMI or type 1 NSTEMI), as early as possible during their hospitalization in the inpatient cardiac units. AMI patients are enrolled if they are: over 18 years old; English-speaking; without auditory, visual, cognitive, or physical impairment; and own a smartphone. Corrie is deployed to patients using a standard operating procedure and consists of the following: (1) a smartphone medication, education, vitals, and follow-up appointments self-management app, (2) smartwatch for reminders and heart rate and physical activity tracking, and (3) a Bluetooth-enabled blood pressure cuff. Patients are either enrolled with their personal iPhone or a loaner iPhone, if they own any other type of smartphone, and a loaner smartwatch for usage during the 30 day study period. The historical comparison group consists of AMI patients, admitted at the same hospitals from October 1 st 2015-2016, who did not receive Corrie. All-cause readmission rates will be evaluated at 30 days after discharge in both groups and Cox proportional hazard models will be used to test differences in time to all-cause first readmission within 30 days between groups, controlling for covariates. To assess cost-effectiveness of Corrie, a Markov Model of cost-effectiveness will be built, based on 30-day readmission rates, to assess the Incremental Cost-Effectiveness Ratio of adopting Corrie. Results/Conclusions: The MiCORE study is being completed and results will be available for AHA QCOR by April 2019.

Pilot Study of Home Vitals and Activity Monitoring for Allogeneic Hematopoietic Cell Transplant Recipients

Can leveraging fast growing technology assist with improving patient outcomes and streamline workflows at the same time? We piloted remote monitoring technologies to find out. In partnership with our hospital's Digital Health team, we provided 39 allogeneic blood and marrow transplant (BMT) recipients with a Bluetooth enabled blood pressure, temperature and activity tracking device. After a one-time set up and pairing with the patient's smartphone, the devices automatically transmitted real-time readings into the patient's permanent electronic medical record (EMR). The patient's transplant care team had the ability to view a dashboard with at home readings. Abnormal readings were also delivered directly to their EMR's inbox. Patients were asked to monitor these readings for at least 100 days post BMT, with the option to continue using the remote devices longer, if desired. Approximately 60% of patients had consistent at home BP and temperature readings recorded in their EMR but only 16% had activity tracking data. We observed the following advantages of remote monitoring: (1) Ease of use by BMT team: The transplant nurse coordinators found it relatively simple to view normal and abnormal at home readings from the EMR. (2) Enhanced patient monitoring: Transplant nurse coordinators were able to see trends before the patient's office visits. For one patient, monitoring prompted a cardiology appointment, where they were able to route home readings to the cardiologist through the EMR. (3) Patient experience: Patients who were able to successfully use the devices generally had positive feedback about them. However, some challenges and opportunities for improvement were identified: (1) Need for better hardware: The activity device used in this pilot was a basic device, future efforts may be better focused on other activity devices. The functionality of our platform was not seamless for Android users. (2) False positive readings: False positive temperature and heart rate readings were an issue (e.g., temperature of 105 recorded due to a family member playing with thermometer, recording heart rate from wife's Apple watch . (3) Patient expectations: Despite educating patients to call their care team with abnormal readings, many patients did not and expected an immediate phone call from their nurse coordinator. (4) Patient experience: Some patients stated that the devices were not easy to use and troubleshooting issues was difficult. We found that remote monitoring of vitals and activity in allogeneic transplant recipients is feasible but has opportunities for improvement before it can be more widely adopted. Workflows were not negatively impacted and visualizing the data was easy. We can see the benefit that at home monitoring could bring, but would need to see improvements with integration, software and hardware before it can be used routinely to care for patients.

Technology Applications: Use of Digital Health Technology to Enable Drug Development.

This pilot study developed and evaluated the feasibility, usability, and perceived satisfaction with an end-user mobile medical application and provider web portal. The two interfaces allowed for remote monitoring, provided daily guidance in the management of hypertension and diarrhea, and allowed for rapid management of adverse events during a clinical trial of olaparib and cediranib. eCO (eCediranib/Olaparib) was designed for patient self-reported, real-time management of hypertension and diarrhea using remote monitoring. eCO links to a Bluetooth-enabled blood pressure (BP) monitor and transmits data to a secure provider web portal. eCO use was assessed for suitability, usability, and satisfaction after 4 weeks using a 17-item questionnaire. Metrics regarding patient-reported BP and diarrhea events were analyzed. Sixteen patients enrolled in the pilot. A total of 98.2% of expected BP values were reported: 94.2% via Bluetooth and 5.8% entered manually. Twelve patients experienced 21 BP events (systolic BP > 140 and/or diastolic BP > 90 mmHg on two consecutive readings); data from cycle 1 were comparable to the study database. Thirteen patients reported diarrhea (more than one stool per 24 hours over baseline) categorized as grade 1 or 2, which was comparable to the study database. Survey analysis showed that patients had statistically significant, positive responses to the use of the eCO application. Patients indicated eCO use made them feel more involved in their care and better connected to their health care team. The only aspect of the application that did not show a statistically significant positive response was the process of reporting diarrhea. The eCO application was designed to assist in managing acute treatment-related events most often associated with treatment discontinuation, need for drug holidays, or dose interruption. Hypertension and diarrhea events reported via eCO allowed rapid provider response and a positive overall patient experience.

Home monitoring with IT-supported specialist management versus home monitoring alone in patients with heart failure: Design and baseline results of the SUPPORT-HF 2 randomized trial

SUPPORT-HF 2 tests the hypothesis that home monitoring with information technology-supported specialist management is more effective in optimizing medical therapy than is home monitoring alone for patients with heart failure. The study was designed as a 2-armed partially blinded parallel randomized controlled trial. Seven sites in the United Kingdom (UK) recruited a total of 202 adults with heart failure at high risk of adverse outcomes and with potential to benefit from remote management (mean age 73 years, 28% female, median left ventricular ejection fraction 37%). Both arms are given a home monitoring and communication kit (Internet-enabled tablet computer, Bluetooth-enabled blood pressure and heart rate monitor, and weighing scale). For each participant, an individualized plan for treatment of heart failure and major comorbidities is developed before randomization. Participants randomized to intervention receive regular feedback to support self-management, and their physicians receive advice on blood investigations and pharmacological treatment from a central specialist heart failure team. Participants in the control arm use the same monitoring system but with no central medical management support. The primary outcome is the use of recommended medical therapy, defined as treatment consistent with the guidelines for management of patients with chronic heart failure, and will be measured as a composite opportunity score. The trial data collection ended in October 2017, and results will be reported in 2019. ISRCTN86212709. Preliminary experience suggests that central provision of tailored specialist management using commercially available low-cost monitoring and computing devices, enhanced by customized applications, is feasible.

Linking clinic and home: a randomized, controlled clinical effectiveness trial of real-time, wireless blood pressure monitoring for older patients with kidney disease and hypertension.

Older adults with chronic kidney disease have a high rate of uncontrolled hypertension. Home monitoring of blood pressure (BP) is an integral part of management, but requires that patients bring records to clinic visits. Telemonitoring interventions, however, have not targeted older, less technologically-skilled populations. Veterans with stage 3 or greater chronic kidney disease and uncontrolled hypertension were randomized to a novel telemonitoring device pairing a Bluetooth-enabled BP cuff with an Internet-enabled hub, which wirelessly transmitted readings (n=28), or usual care (n=15). Home recordings were reviewed weekly and telemonitoring participants were contacted if BP was above goal. The prespecified primary endpoints were improved data exchange and device acceptability. Secondary endpoint was BP change. Forty-three participants (average age 68 years, 75% white) completed the 6-month study. Average start-of-study BP was 147/78 mmHg. Those in the intervention arm had a median of 29 (IQR 22, 53) transmitted BP readings per month, with 78% continuing to use the device regularly, whereas only 20% of those in the usual care group brought readings to in-person visits. The median number of telephone contacts triggered by the wireless monitoring was 2 (IQR 1, 4) per patient. Both groups had a significant improvement in systolic BP (P<0.05, for both changes); systolic BP fell a median of 13 mmHg in monitored participants compared with 8.5 mmHg in usual care participants (P for comparison 0.31). This low-cost wireless monitoring strategy led to greater sharing of data between patients and clinic and produced a trend toward improvements in BP control over usual care at 6 months.