Background and Objective: Portable and readily accessible wellness devices can aid vital sign measuring for those interested in tracking their health. In this diagnostic accuracy study, we evaluated the performance of the VitalWellness device (VW), a wireless, compact, noninvasive device that measures four vital signs (VS) - blood pressure (BP), heart rate (HR), respiratory rate (RR), and body temperature (BT) - using the index finger and forehead. Methods: Adult volunteers with VS that fell both within and outside of the normal physiological range were enrolled to provide BP, HR, RR, and BT measurements using both the VW and Food and Drug Administration-approved reference devices. A subgroup of participants underwent an additional test to analyze the VW’s performance on HR and RR outside of normal physiological ranges. Statistical measurements were plotted on scatter and Bland-Altman plots. Sensitivity analyses to evaluate the VW’s performance by gender, skin color, finger size, and auxiliary activities were performed. Results: A total of 263 participants completed the study. On an average, systolic BP measured using the VW was 10 mmHg lower than that of the reference device (correlation coefficient r = 0.7), whereas diastolic BP was 3 mmHg lower ( r = 0.6), and RR was 2 bpm lower ( r = 0.7). VW HR and BT measurements were, on average, 1 bpm and 0.3°F higher than the corresponding reference measurements ( r = 0.9 and r = 0.3), respectively. Conclusion: The VW device is well-suited for home-based, nonmedical monitoring of HR, RR, and BP. Further improvement in measurement accuracy is required to enable applications for medical use.

Background Wellness devices for health tracking have gained popularity in recent years. Additionally, portable and readily accessible wellness devices have several advantages when compared to traditional medical devices found in clinical environments. Building tools for patients to manage their health independently may benefit their health in the long run by improving health care providers’ (HCPs) awareness of their patients’ health information outside of the clinic. Increased access to portable wellness devices that track vital signs may increase how patients and HCPs track and monitor chronic conditions which can improve health outcomes. The VitalWellness is a portable wellness device that can potentially aid vital sign measuring for those interested in tracking their health. Objective In this diagnostic accuracy study, we evaluated the clinical performance of the VitalWellness, a wireless, compact, non-invasive device that measures four vital signs using the index finger and forehead against reference vital signs devices used in the hospital setting. Methods Volunteers age ≥18 years were enrolled to provide blood pressure (BP), heart rate (HR), respiratory rate (RR), and body temperature. We recruited volunteers with vital signs that fell within and outside of the normal physiological range, depending on the measurements they consented to undergo. A subgroup of eligible volunteers were asked to undergo an exercise test, aerobic step test and/or a paced breathing test to analyze the VitalWellness device's performance on vital signs outside of the normal physiological ranges for HR and RR. Vital signs measurements were collected with the VitalWellness device and FDA-approved reference devices. Mean, standard deviation, mean difference, standard deviation of difference, standard error of mean difference, and correlation coefficients were calculated for measurements collected; these measurements were plotted on a scatter plot and a Bland-Altman plot. Sensitivity analyses were performed to evaluate the performance of the VitalWellness device by gender, skin color, finger size, and in the presence of artifacts. Results We enrolled 265 volunteers in the study and 2 withdrew before study completion. The majority of volunteers were female (62%), predominately white (63%), graduated from college or post college (67%), and employed (59%). There was a moderately strong linear relationship between VitalWellness BP and reference BP (r=0.7, P<.05) and bewteen VitalWellness RR and reference RR measurements (r=0.7, P<.05). The VitalWellness HR readings were significantly in line with the reference HR readings (r=0.9, P<.05). There was a weaker linear relationship between VitalWellness temperature and reference temperature (r=0.3, P<.05). There were no differences in performance of the VitalWellness device by gender, skin color or in the presence of artifacts. Finger size was associated with differential performance for RR. Conclusions Overall, the VitalWellness device performed well in taking BP, HR and RR when compared to FDA-approved reference devices and has potential serve as a wellness device. To test adaptability and acceptability, future research may evaluate user’s interactions and experiences with the VitalWellness device at home. In addition, the next phase of the study will evaluate transmitting vital sign information from the VitalWellness device to an online secured database where information can be shared with HCPs within seconds of measurement.

Background Type 2 diabetes (T2D) is the seventh leading cause of death (2017) in the United States, and by 2030 it is estimated that it will affect 439 million globally. Effective glycemic control can be challenging for patients. A tool to guide patients’ in their self-management behaviors and share this data with their physician may improve insulin adherence leading to lower HbA1c. We examined an integrated diabetes management (IDM) system that utilizes a Bluetooth-enabled insulin event capture device, a Bluetooth-enabled glucometer, and an Android smartphone app. IDM data can be viewed by clinicians in the electronic medical record (EMR). Objective The primary aim of this study is to describe how app use is related to insulin adherence, blood glucose measurements, meal snapshots, and step count. Secondarily, we assessed the impact on HbA1c levels over a 3- and 6-month period. Methods Thirty-five participants were enrolled from Boston-area hospitals in this single-arm pilot study. Use of the IDM system was defined as the number of days per week participants logged into the app and moved past the home screen. Three app use groups were created: low app use (0.33-2.46 days per week), medium app use (2.54-5.08 days per week), and high app use (>5.4 days per week). Adherence to insulin, blood glucose measurements, and meal snapshots were defined as a ratio of actual weekly events recorded by participants’ app use divided by their physician’s recommendation. Step count was defined as the total weekly steps for each participant. Daily app-generated data on app use and indicators of diabetes management were collected. HbA1c levels were assessed via blood test at enrollment, 3-months, and 6-months. Using a hierarchical linear mixed model, we examined changes in outcome measures while accounting for random intercepts and slopes to control for variation in individual outcomes over the study. Results Overall app use (average unique days using the app per week) declined from 6.19 days to 3.00 days (at 1 and 24 weeks, respectively). Participants with high app use had significant improvement in bolus and basal insulin adherence per week (0.009 P=.041 [95% CI 0.0004 to 0.018] and 0.016 P<.001 [95% CI 0.0079 to 0.023], respectively), but participants had no significant improvements in blood glucose and meal snapshot adherence or absolute step count. HbA1c significantly decreased per week (coefficient –0.025 [95% CI –0.044 to –0.007], P=.007) with an overall change of 0.6. Participants with high app use significantly improved their HbA1c per week (–0.037 P=.016 [–0.066 to –0.0067]) compared to participants with medium and low app use, yielding a total improvement of 0.88 over 24 weeks. Conclusions Results show that bolus and basal insulin may have increased with higher app use. HbA1c significantly improved over the course of the study, along with significantly greater improvement in HbA1c among participants with higher app use compared to participants in the middle or low app use groups. This study is not designed or intended to evaluate efficacy but provides results to guide the future design and development of this prototype IDM system.

Background Participant recruitment, especially for frail, elderly, hospitalized patients, remains one of the greatest challenges for many research groups. Traditional recruitment methods such as chart reviews are often inefficient, low-yielding, time consuming, and expensive. Best Practice Alert (BPA) systems have previously been used to improve clinical care and inform provider decision making, but the system has not been widely used in the setting of clinical research. Objective The primary objective of this quality-improvement initiative was to develop, implement, and refine a silent Best Practice Alert (sBPA) system that could maximize recruitment efficiency. Methods The captured duration of the screening sessions for both methods combined with the allotted research coordinator hours in the Emerald-COPD (chronic obstructive pulmonary disease) study budget enabled research coordinators to estimate the cost-efficiency. Results Prior to implementation, the sBPA system underwent three primary stages of development. Ultimately, the final iteration produced a system that provided similar results as the manual Epic Reporting Workbench method of screening. A total of 559 potential participants who met the basic prescreen criteria were identified through the two screening methods. Of those, 418 potential participants were identified by both methods simultaneously, 99 were identified only by the Epic Reporting Workbench Method, and 42 were identified only by the sBPA method. Of those identified by the Epic Reporting Workbench, only 12 (of 99, 12.12%) were considered eligible. Of those identified by the sBPA method, 30 (of 42, 71.43%) were considered eligible. Using a side-by-side comparison of the sBPA and the traditional Epic Reporting Workbench method of screening, the sBPA screening method was shown to be approximately four times faster than our previous screening method and estimated a projected 442.5 hours saved over the duration of the study. Additionally, since implementation, the sBPA system identified the equivalent of three additional potential participants per week. Conclusions Automation of the recruitment process allowed us to identify potential participants in real time and find more potential participants who meet basic eligibility criteria. sBPA screening is a considerably faster method that allows for more efficient use of resources. This innovative and instrumental functionality can be modified to the needs of other research studies aiming to use the electronic medical records system for participant recruitment.

Overactive bladder (OAB), defined by urinary urgency with or without urge urinary incontinence (UI), usually with frequency and nocturia, can significantly impact patient’s quality of life. Tracking symptoms is an important part of OAB management and has been shown to assist in enhancing patient interaction with health care providers (HCP) when discussing solutions for symptom management. The primary goal of this study was to assess the usability and acceptability of an Android smartphone mobile app designed to help participants learn about OAB symptom management through tracking and self-management. Secondarily, we also assessed engagement with the app over the three-month study period. Eligible participants were experiencing OAB symptoms without an existing enlarged prostate or urinary tract infection (BPH/UTI), and enrolled through referrals from within the Partners Healthcare network. The mobile app was installed at the enrollment visit, and participants were instructed to complete monthly, 3-day symptom journals, as well as surveys and optional free-text notes for 12 weeks. Additionally, medication reminders, Kegel and bladder training exercises were available for use in the app. A visit with their HCP was scheduled between weeks 6 and 12 of the study for the HCP and participant to review collected symptom data via an app-linked portal. Qualitative input from the HCP, closeout participant interviews and app usage data (percent viewed and number of hits) were used to assess participant engagement. Closeout interviews (n=10) also assessed usability of the various app features. Demographic and usability satisfaction data were collected via questionnaires developed by investigators. Descriptive analyses were conducted to present the demographic and usability data. NVivo for Mac (version 11) was used to conduct a thematic analysis on qualitative data. Of the total enrolled (n=33), 26 participants completed the study. Participant engagement with the app was 100% for months one and two of the study then dropped to 72% by month three. Most participants (80%) reported using the app as needed vs regularly. As a group, female participants >50 years demonstrated the highest engagement (75%) at closeout. The most used app feature was the free-text diary feature (100%; 5516 hits), followed by the “event log” (100%; 2105 hits). The majority of other app features were also rated as useful by participants (52-100%). Participant interviews found the app was a valuable OAB information source, simplifying symptom tracking and follow-through on clinician recommendations. Perceived usefulness of the portal varied between primary care providers and specialists. Participants indicated the app was “Easy to Learn” (96%), “Simple to Use” (92%), useful for understanding changes in symptoms (91%), enabled better symptom tracking (96%), and facilitated communication with their HCP (75%). A mobile app to increase awareness of OAB symptoms improved confidence in self-management for participants and increased access to data for decision making and participant communication for specialists. Participant-reported outcomes indicate that the tracking void frequency and urgency features were very useful, while other features such as medication reminders, pad usage, bladder and Kegel trainings were used less frequently among participants.