Patient‐Centered Home Care Using Digital Medicine and Telemetric Data for Hypertension: Feasibility and Acceptability of Objective Ambulatory Assessment

Abstract

Objective information that can be passively obtained in an ambulatory setting could be potentially useful for determining appropriate care in blood pressure (BP) management. This study utilized digital medicine (DM) prototypes and telemetric data acquisition to directly confirm medication use and to assess habits of daily living in a hypertensive population. Thirty‐seven patients (23 men age 62±9 years) used the system for 6 weeks. DM prototypes consisted of valsartan 80 mg or 160 mg placed in a gelatin hemicapsule with an excipient tablet as a “stopper,” with a poppy seed–sized ingestible sensor (IS) made of foodstuff on its external surface and capable of creating a biogalvanic current on ingestion to alert a wearable sensor (WS) that was worn on the torso. Passive data collection included IS ingestion dates and times, daily step count, BP, and weight. Automatic short message service (SMS) reminders were sent whenever BP or weight values were not received. Passive detection of DM ingestion was 98% when compared with directly observed dosing. Mean taking and timing adherence rates were 90% and 83%, respectively, and the average step count at a pace of ≥60 steps per minute was 2.0±1.5 h/d. An automatic SMS was sent and 100% confirmed for 251 BP and 14 weight values that were not received. Mild and transient WS‐related skin irritation was the most common device‐related adverse event. There were no serious or unanticipated adverse events. Ninety percent of patients did not mind swallowing a DM capsule, and 75% had a positive overall experience with the system. Ambulatory evaluation of medication adherence and habits of daily living appear to be feasible and acceptable using DM and passive acquisition of telemetric data.

Real‐Time and Wireless Assessment of Adherence to Antiretroviral Therapy With Co‐Encapsulated Ingestion Sensor in HIV‐Infected Patients: A Pilot Study

“…Satisfaction was similar in other studies, such as one that included 37 individuals monitored for 16 weeks of their hypertension treatment. In this case, 40% complained of mild and transient skin patch‐associated irritation with 90% responding that they were satisfied with the co‐encapsulated pill, and 75% stating that the overall experience was positive . Eisenberger et al .…”

“…The PDHF system has been used in a variety of patient populations in whom treatment adherence is important, such as those with hypertension, mental health conditions, tuberculosis, and transplantation. [9][10][11][12] The PDHF system has proven to be highly accurate for detecting ingestions and without serious adverse events. 8 The satisfaction responses in our pilot were similar to those previously reported in patients with diseases other than HIV.…”

“…This technology has been used in those treated for a variety of disease states, including hypertension, mental health conditions, tuberculosis, and organ transplantation. [9][10][11][12][13] Studies have reported at least 95% detection sensitivity and 99.7% specificity. 8,12 However, this device has not yet been tested for ARV therapy use in HIV-infected individuals.…”

“…transient skin patch-associated irritation with 90% responding that they were satisfied with the co-encapsulated pill, and 75% stating that the overall experience was positive. 11 Eisenberger et al 9 reported a study of 20 patients who underwent kidney transplantation using the PDHF system with seven experiencing a rash or erythema from the patch, all occurring in the first 4 weeks of follow-up with two stopping because of this adverse event.…”

“…A short message system can be programmed in response to the receipt (or not) of the ingestion signal, for example, a reinforcing message if a dose is taken and a reminder after a scheduled dose is missed. This technology has been used in those treated for a variety of disease states, including hypertension, mental health conditions, tuberculosis, and organ transplantation . Studies have reported at least 95% detection sensitivity and 99.7% specificity .…”