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 The VitalWellness device is a portable wellness device that can potentially aide vital sign measuring for those interested in tracking their health. Objective In this diagnostic accuracy study, we evaluated the performance of the VitalWellness device, a wireless, compact, non-invasive device that measures four vital signs (blood pressure (BP), heart rate (HR), respiratory rate (RR), and body temperature using the index finger and forehead. Methods Volunteers age ≥18 years were enrolled to provide blood pressure (BP), heart rate (HR), respiratory rate (RR), and body temperature. We recruited participants with vital signs that fell within and outside of the normal physiological range. A sub-group of eligible participants 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 265 volunteers enrolled in the study and 2 withdrew before study completion. Majority of the 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 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 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 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 Studies show that good communication between doctors and patients and among all caregivers who interface with patients directly results in better clinical outcomes, reduced costs, greater patient satisfaction, and lower rates of physician burnout. The main purpose of this pilot study was to test the acceptability and usability of a mobile phone app (HARP), an app designed to improve communication and data collection among nonclinical care givers such as home health aides and case managers of patients who receive care at home. The home health aides collected information on patient’s mood, energy, medication adherence, potential falls and appetite level for the day. This information is summarized in postvisit, weekly and final discharge summary reports via an online dashboard and sent to the patient’s case manager at different time points. We assessed the usability and acceptability of the HARP mobile app. Objective This is a quality improvement pilot project geared towards assessing the usability and acceptability of a mobile app developed to facilitate patient data collection by trained home health aides who work together on a regular basis to provide home-based care to discrete subpopulations of patients. Methods Four home health aides were recruited from Partners Healthcare at Home to use the app to collect data on at least 12 patients. Eligible patients received care from 1 of the 4 home health aides for at least 23 days and scheduled to have at least 5 home visits during this time. Each of the patients were followed for a minimum of 23 days and a maximum 60 days in which home health aides collected patient data using the app. Postvisit reports, weekly reports and discharge summary reports were shared with the patient’s case managers. Data collection included acceptability and satisfaction data from all home health aides and case managers via surveys. A subgroup of 2 case managers and 2 home health aides participated in semistructured interviews. Results 9 have completed the project to date, 5 patients dropped out due to discharge from Partners Healthcare at Home care. The interim data included is from 8 case managers and 4 home health aides who provide care to one or more of the 9 patients who completed the project. Most case managers (75%) found postvisit and weekly reports useful and 87% found tracking mood and energy helpful. About 75% felt tracking appetite and falls via the HARP app helpful. Almost all case managers (87%), agreed that integrating a tool like the HARP app to the EMR would help them provide better care to their patients. Three out of four home health aides (75%) felt that the app easy to use or learn about once they received instructions and were willing to consider using the app in their workflow. Conclusions Acceptability and usability of HARP app was considerably high among case managers. The acceptability of the app varied among home health aides, some found information useful and believed the app has potential to help personalize patient care. Future research would require exploring other patient information that is useful to all staff involved in the clinical workflow and increase adoption of tool in clinical settings. Such tools could potentially reduce clinician burnout and improve patient outcomes.
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