Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole

Timothy Peters-Strickland,1 Linda Pestreich,1 Ainslie Hatch,2 Shashank Rohatagi,1 Ross A Baker,1 John P Docherty,2 Lada Markovtsova,1 Praveen Raja,3 Peter J Weiden,4 David P Walling5 1Otsuka Pharmaceutical Development & Commercialization, Inc., 2ODH, Inc., Princeton, NJ, 3Proteus Digital He...

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Autores principales:	Peters-Strickland T, Pestreich L, Hatch A, Rohatagi S, Baker RA, Docherty JP, Markovtsova L, Raja P, Weiden PJ, Walling DP
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	adherence antipsychotics aripiprazole digital medicine schizophrenia usability Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/26789ecdaa46435bae84099e5b31868a
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spelling	oai:doaj.org-article:26789ecdaa46435bae84099e5b31868a2021-12-02T03:18:05ZUsability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole1178-2021https://doaj.org/article/26789ecdaa46435bae84099e5b31868a2016-10-01T00:00:00Zhttps://www.dovepress.com/usability-of-a-novel-digital-medicine-system-in-adults-with-schizophre-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Timothy Peters-Strickland,1 Linda Pestreich,1 Ainslie Hatch,2 Shashank Rohatagi,1 Ross A Baker,1 John P Docherty,2 Lada Markovtsova,1 Praveen Raja,3 Peter J Weiden,4 David P Walling5 1Otsuka Pharmaceutical Development & Commercialization, Inc., 2ODH, Inc., Princeton, NJ, 3Proteus Digital Health, Inc., Redwood City, CA, 4Department of Psychiatry, University of Illinois, Chicago, IL, 5CNS Network, LLC, Long Beach, CA, USA Objective: Digital medicine system (DMS) is a novel drug–device combination that objectively measures and reports medication ingestion. The DMS consists of medication embedded with an ingestible sensor (digital medicine), a wearable sensor, and software applications. This study evaluated usability of the DMS in adults with schizophrenia rated by both patients and their health care providers (HCPs) during 8-week treatment with prescribed doses of digital aripiprazole.Methods: Six US sites enrolled outpatients into this Phase IIa, open-label study (NCT02219009). The study comprised a screening phase, a training phase (three weekly site visits), and a 5-week independent phase. Patients and HCPs independently rated usability of and satisfaction with the DMS.Results: Sixty-seven patients were enrolled, and 49 (73.1%) patients completed the study. The mean age (SD) of the patients was 46.6 years (9.7 years); the majority of them were male (74.6%), black (76.1%), and rated mildly ill on the Clinical Global Impression – Severity scale (70.1%). By the end of week 8 or early termination, 82.1% (55/67) of patients had replaced the wearable sensor independently or with minimal assistance, based on HCP rating. The patients used the wearable sensor for a mean (SD) of 70.7% (24.7%) and a median of 77.8% of their time in the trial. The patients contacted a call center most frequently at week 1. At the last visit, 78% (47/60) of patients were somewhat satisfied/satisfied/extremely satisfied with the DMS.Conclusion: A high proportion of patients with schizophrenia were able to use the DMS and reported satisfaction with the DMS. These data support the potential utility of the DMS in clinical practice. Keywords: adherence, antipsychotics, aripiprazole, digital medicine, schizophrenia, usabilityPeters-Strickland TPestreich LHatch ARohatagi SBaker RADocherty JPMarkovtsova LRaja PWeiden PJWalling DPDove Medical Pressarticleadherenceantipsychoticsaripiprazoledigital medicineschizophreniausabilityNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 12, Pp 2587-2594 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	adherence antipsychotics aripiprazole digital medicine schizophrenia usability Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	adherence antipsychotics aripiprazole digital medicine schizophrenia usability Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Peters-Strickland T Pestreich L Hatch A Rohatagi S Baker RA Docherty JP Markovtsova L Raja P Weiden PJ Walling DP Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole
description	Timothy Peters-Strickland,1 Linda Pestreich,1 Ainslie Hatch,2 Shashank Rohatagi,1 Ross A Baker,1 John P Docherty,2 Lada Markovtsova,1 Praveen Raja,3 Peter J Weiden,4 David P Walling5 1Otsuka Pharmaceutical Development & Commercialization, Inc., 2ODH, Inc., Princeton, NJ, 3Proteus Digital Health, Inc., Redwood City, CA, 4Department of Psychiatry, University of Illinois, Chicago, IL, 5CNS Network, LLC, Long Beach, CA, USA Objective: Digital medicine system (DMS) is a novel drug–device combination that objectively measures and reports medication ingestion. The DMS consists of medication embedded with an ingestible sensor (digital medicine), a wearable sensor, and software applications. This study evaluated usability of the DMS in adults with schizophrenia rated by both patients and their health care providers (HCPs) during 8-week treatment with prescribed doses of digital aripiprazole.Methods: Six US sites enrolled outpatients into this Phase IIa, open-label study (NCT02219009). The study comprised a screening phase, a training phase (three weekly site visits), and a 5-week independent phase. Patients and HCPs independently rated usability of and satisfaction with the DMS.Results: Sixty-seven patients were enrolled, and 49 (73.1%) patients completed the study. The mean age (SD) of the patients was 46.6 years (9.7 years); the majority of them were male (74.6%), black (76.1%), and rated mildly ill on the Clinical Global Impression – Severity scale (70.1%). By the end of week 8 or early termination, 82.1% (55/67) of patients had replaced the wearable sensor independently or with minimal assistance, based on HCP rating. The patients used the wearable sensor for a mean (SD) of 70.7% (24.7%) and a median of 77.8% of their time in the trial. The patients contacted a call center most frequently at week 1. At the last visit, 78% (47/60) of patients were somewhat satisfied/satisfied/extremely satisfied with the DMS.Conclusion: A high proportion of patients with schizophrenia were able to use the DMS and reported satisfaction with the DMS. These data support the potential utility of the DMS in clinical practice. Keywords: adherence, antipsychotics, aripiprazole, digital medicine, schizophrenia, usability
format	article
author	Peters-Strickland T Pestreich L Hatch A Rohatagi S Baker RA Docherty JP Markovtsova L Raja P Weiden PJ Walling DP
author_facet	Peters-Strickland T Pestreich L Hatch A Rohatagi S Baker RA Docherty JP Markovtsova L Raja P Weiden PJ Walling DP
author_sort	Peters-Strickland T
title	Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole
title_short	Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole
title_full	Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole
title_fullStr	Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole
title_full_unstemmed	Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole
title_sort	usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/26789ecdaa46435bae84099e5b31868a
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Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole

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