ABSTRACT
BACKGROUND: Co-encapsulated antiretrovirals (ARVs) with ingestible sensor (IS) has the capacity to monitor adherence in real-time using a sensor patch, a mobile device, and supporting software. We evaluated the acceptability, effectiveness, and sustainability of the IS system with real-time text reminders. METHODS: Participants were recruited from HIV clinics in Los Angeles and were randomised 1:1 to IS or usual care (UC) group. Adherence to ARVs (primary outcome) was measured by IS system (IS group only), plasma ARV concentration, and self-report. IS-measured adherence was clustered by group-based trajectory model and was validated by ARV concentration summarized by integrated pharmacokinetic adherence measure (IPAM) score. HIV RNA viral load (VL) was compared between IS and UC group. FINDINGS: A total of 112 (IS = 54, UC = 58) participants who completed baseline with at least one follow-up data collection were included in analyses. Overall satisfaction rate for the IS system was >90%. The IPAM score was higher (0.018, 95% CI: -0.098-0.134, p = 0.75) and VL decayed faster (-0.020, 95% CI: -0.042-0.002, p = 0.08) in the IS group compared with the UC group. The ingestible sensor system was well tolerated by study participants. INTERPRETATION: The IS system was well accepted by participants and its use was associated with improved adherence and lower HIV RNA VL. The findings provide a potentially effective strategy for improving adherence. FUNDING: This work was supported by grant R01-MH110056 from the National Institute of Mental Health (NIMH)/National Institutes of Health (NIH). Y. Wang was in part supported by the NIMH/NIH award T32MH080634. E. Daar was in part supported by the National Center for Advancing Translational Sciences through UCLACTSI Grant UL1TR001881. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Subject(s)
HIV Infections , Medication Adherence , Humans , HIV Infections/drug therapy , Anti-Retroviral Agents/therapeutic use , RNA/therapeutic use , Viral LoadABSTRACT
BACKGROUND: Hypertension and type 2 diabetes mellitus are major modifiable risk factors for cardiac, cerebrovascular, and kidney diseases. Reasons for poor disease control include nonadherence, lack of patient engagement, and therapeutic inertia. OBJECTIVE: The aim of this study was to assess the impact on clinic-measured blood pressure (BP) and glycated hemoglobin (HbA1c) using a digital medicine offering (DMO) that measures medication ingestion adherence, physical activity, and rest using digital medicines (medication taken with ingestible sensor), wearable sensor patches, and a mobile device app. METHODS: Participants with elevated systolic BP (SBP ≥140 mm Hg) and HbA1c (≥7%) failing antihypertensive (≥2 medications) and oral diabetes therapy were enrolled in this three-arm, 12-week, cluster-randomized study. Participants used DMO (includes digital medicines, the wearable sensor patch, and the mobile device app) for 4 or 12 weeks or received usual care based on site randomization. Providers in the DMO arms could review the DMO data via a Web portal. In all three arms, providers were instructed to make medical decisions (medication titration, adherence counseling, education, and lifestyle coaching) on all available clinical information at each visit. Primary outcome was change in SBP at week 4. Other outcomes included change in SBP and HbA1c at week 12, and low-density lipoprotein cholesterol (LDL-C) and diastolic blood pressure (DBP) at weeks 4 and 12, as well as proportion of patients at BP goal (<140/90 mm Hg) at weeks 4 and 12, medical decisions, and medication adherence patterns. RESULTS: Final analysis included 109 participants (12 sites; age: mean 58.7, SD years; female: 49.5%, 54/109; Hispanic: 45.9%, 50/109; income ≤ US $20,000: 56.9%, 62/109; and ≤ high school education: 52.3%, 57/109). The DMO groups had 80 participants (7 sites) and usual care had 29 participants (5 sites). At week 4, DMO resulted in a statistically greater SBP reduction than usual care (mean -21.8, SE 1.5 mm Hg vs mean -12.7, SE 2.8 mmHg; mean difference -9.1, 95% CI -14.0 to -3.3 mm Hg) and maintained a greater reduction at week 12. The DMO groups had greater reductions in HbA1c, DBP, and LDL-C, and a greater proportion of participants at BP goal at weeks 4 and 12 compared with usual care. The DMO groups also received more therapeutic interventions than usual care. Medication adherence was ≥80% while using the DMO. The most common adverse event was a self-limited rash at the wearable sensor site (12%, 10/82). CONCLUSIONS: For patients failing hypertension and diabetes oral therapy, this DMO, which provides dose-by-dose feedback on medication ingestion adherence, can help lower BP, HbA1c, and LDL-C, and promote patient engagement and provider decision making. TRIAL REGISTRATION: Clinicaltrials.gov NCT02827630; https://clinicaltrials.gov/show/NCT02827630 (Archived by WebCite at http://www.webcitation.org/6rL8dW2VF).
Subject(s)
Diabetes Mellitus, Type 2/therapy , Hypertension/therapy , Telemedicine/statistics & numerical data , Diabetes Mellitus, Type 2/drug therapy , Female , Humans , Hypertension/drug therapy , Male , Medication Adherence , Middle Aged , Pilot Projects , Prospective Studies , Treatment OutcomeABSTRACT
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.
Subject(s)
Blood Pressure Monitoring, Ambulatory/instrumentation , Hypertension/drug therapy , Medication Adherence/statistics & numerical data , Aged , Feasibility Studies , Female , Home Care Services , Humans , Male , Middle Aged , Patient-Centered CareABSTRACT
In this paper, we describe the design and performance of the first integrated-circuit microsensor developed for daily ingestion by patients. The ingestible sensor is a device that allows patients, families, and physicians to measure medication ingestion and adherence patterns in real time, relate pharmaceutical compliance to important physiologic metrics, and take appropriate action in response to a patient's adherence pattern and specific health metrics. The design and theory of operation of the device are presented, along with key in-vitro and in-vivo performance results. The chemical, toxicological, mechanical, and electrical safety tests performed to establish the device's safety profile are described in detail. Finally, aggregate results from multiple clinical trials involving 412 patients and 5656 days of system usage are presented to demonstrate the device's reliability and performance as part of an overall digital health feedback system.
Subject(s)
Gastrointestinal Contents/chemistry , Medication Adherence , Monitoring, Ambulatory/instrumentation , Tablets, Enteric-Coated/analysis , Tablets, Enteric-Coated/chemistry , Wireless Technology/instrumentation , Administration, Oral , Animals , Conductometry/instrumentation , Dogs , Drug Monitoring , Eating , Equipment Design , Equipment Failure Analysis , Humans , Hydrogen-Ion Concentration , Pharmaceutical Preparations/administration & dosage , Pharmaceutical Preparations/analysis , Pharmaceutical Preparations/chemistry , TransducersSubject(s)
Depression , Phobic Disorders , Suicide Prevention , Suicide , Syphilis , Depression/diagnosis , Depression/etiology , History, 20th Century , Humans , Periodicals as Topic/history , Phobic Disorders/diagnosis , Phobic Disorders/etiology , Psychological Techniques , Suicide/psychology , Syphilis/complications , Syphilis/history , Syphilis/psychologyABSTRACT
Taking oral medication on a prescribed schedule can be a nuisance, especially for elderly individuals and busy people with lots of things on their minds. Nonetheless, taking medication as prescribed is important for maintaining health and well-being. In cases where medication use is part of a clinical trial, taking prescribed medication is important to the entire investigation and outcome of the study, including the determination of whether a drug is effective and safe.
Subject(s)
Directly Observed Therapy/instrumentation , Directly Observed Therapy/methods , Electronics, Medical/instrumentation , Medication Adherence , Telemetry/instrumentation , Adult , Equipment Design , Female , Humans , Male , Middle AgedABSTRACT
En el marco de las Primeras Jornadas Internacionales de Minimización y Reciclaje de Residuos los autores presentaron un trabajo resultado de su investigación sobre la situación en materia de residuos en el ámbito municipal, en esta parte del mundo, que nos toca. Acostumbrados tal vez a lenguajes más complacientes o eufemísticos, nos pone ante el espejo sin contemplaciones
Subject(s)
Refuse Disposal , RecyclingABSTRACT
En el marco de las Primeras Jornadas Internacionales de Minimización y Reciclaje de Residuos los autores presentaron un trabajo resultado de su investigación sobre la situación en materia de residuos en el ámbito municipal, en esta parte del mundo, que nos toca. Acostumbrados tal vez a lenguajes más complacientes o eufemísticos, nos pone ante el espejo sin contemplaciones
Subject(s)
Refuse Disposal , RecyclingABSTRACT
Este estudio examina un número de temas relacionados con el estado actual del reciclaje y estrategias de manejo de residuos en Estados Unidos. La segunda parte describe el estado de reciclaje y las tendencias relacionadas en Estados Unidos incluyendo los porcentajes de reciclaje y la infraestructura asociada. La tercera parte presenta información de varios estudios que han analizado los factores que influyen en el nivel de reciclaje. La cuarta pate revisa diversos análisis que valoran el costo del reciclaje y considera los factores que pueden efectuar los niveles de costo. La quinta parte examina los mercados para materiales reciclables. La sexta parte presenta cálculos de los beneficios netos del reciclaje. Finalmente la septima parte proporciona algunas sugerencias políticas y comentarios
Subject(s)
Recycling , Solid Waste UseABSTRACT
Se plantea una breve exposición de la situación socioeconómica y el impacto que tiene la administración de los residuos sólidos sobre el manejo ambiental de la región. También se discute importantes temas técnicos relacionados con el manejo del residuo sólido, desde la caracterización del residuo hasta la disposición final. Se realiza una referencia específica a los procesos utilizados en la recuperación de recursos de residuos sólidos municipales. Además de temas técnicos son presentados los aspectos políticos, administrativos, legales, institucionales y financieros
Subject(s)
Recycling , Solid Waste Volume , Solid Waste Characteristics , Solid Waste Collection , Solid Waste ProcessingABSTRACT
Se plantea una breve exposición de la situación socioeconómica y el impacto que tiene la administración de los residuos sólidos sobre el manejo ambiental de la región. También se discute importantes temas técnicos relacionados con el manejo del residuo sólido, desde la caracterización del residuo hasta la disposición final. Se realiza una referencia específica a los procesos utilizados en la recuperación de recursos de residuos sólidos municipales. Además de temas técnicos son presentados los aspectos políticos, administrativos, legales, institucionales y financieros
Subject(s)
Solid Waste Characteristics , Solid Waste Collection , Jurisprudence , Solid Waste Processing , Recycling , Solid Waste VolumeABSTRACT
Este estudio examina un número de temas relacionados con el estado actual del reciclaje y estrategias de manejo de residuos en Estados Unidos. La segunda parte describe el estado de reciclaje y las tendencias relacionadas en Estados Unidos incluyendo los porcentajes de reciclaje y la infraestructura asociada. La tercera parte presenta información de varios estudios que han analizado los factores que influyen en el nivel de reciclaje. La cuarta pate revisa diversos análisis que valoran el costo del reciclaje y considera los factores que pueden efectuar los niveles de costo. La quinta parte examina los mercados para materiales reciclables. La sexta parte presenta cálculos de los beneficios netos del reciclaje. Finalmente la septima parte proporciona algunas sugerencias políticas y comentarios
Subject(s)
Recycling , Solid Waste UseABSTRACT
Contenido: Introducción.- Generalidades.- Ubicación de un relleno sanitario.- Diseño de un relleno sanitario.- Requisitos del diseño de un relleno sanitario.- Clausura y cuidados post-clausura de un relleno sanitario.- Uso final de un relleno sanitario
Subject(s)
Sanitary Landfill , Selection of the Waste Treatment SiteABSTRACT
Contenido: Introducción.- Generalidades.- Ubicación de un relleno sanitario.- Diseño de un relleno sanitario.- Requisitos del diseño de un relleno sanitario.- Clausura y cuidados post-clausura de un relleno sanitario.- Uso final de un relleno sanitario
Subject(s)
Sanitary Landfill , Selection of the Waste Treatment SiteABSTRACT
Contenido: Introducción.- Generalidades.- Ubicación de un relleno sanitario.- Diseño de un relleno sanitario.- Requisitos del diseño de un relleno sanitario.- Clausura y cuidados post-clausura de un relleno sanitario.- Uso final de un relleno sanitario
