A multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness

Alex Kopelowicz,1 Ross A Baker,2 Cathy Zhao,2 Claudette Brewer,3 Erica Lawson,3 Timothy Peters-Strickland2 1David Geffen School of Medicine, University of California, Los Angeles, CA, 2Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, 3Otsuka Pharmaceutical Development an...

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Autores principales:	Kopelowicz A, Baker RA, Zhao C, Brewer C, Lawson E, Peters-Strickland T
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	schizophrenia bipolar I disorder major depressive disorder digital medicine adherence Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/1ca2a42b126d4ded8b8cb9eb22224a61
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spelling	oai:doaj.org-article:1ca2a42b126d4ded8b8cb9eb22224a612021-12-02T01:09:25ZA multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness1178-2021https://doaj.org/article/1ca2a42b126d4ded8b8cb9eb22224a612017-10-01T00:00:00Zhttps://www.dovepress.com/a-multicenter-open-label-pilot-study-evaluating-the-functionality-of-a-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Alex Kopelowicz,1 Ross A Baker,2 Cathy Zhao,2 Claudette Brewer,3 Erica Lawson,3 Timothy Peters-Strickland2 1David Geffen School of Medicine, University of California, Los Angeles, CA, 2Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, 3Otsuka Pharmaceutical Development and Commercialization Inc., Rockville, MD, USA Background: Medication nonadherence is common in the treatment of serious mental illness (SMI) and leads to poor outcomes. The digital medicine system (DMS) objectively measures adherence with oral aripiprazole in near-real time, allowing recognition of adherence issues. This pilot study evaluated the functionality of an integrated call center in optimizing the use of the DMS. Materials and methods: An 8-week, open-label, single-arm trial at four US sites enrolled adults with bipolar I disorder, major depressive disorder, and schizophrenia on stable oral aripiprazole doses and willing to use the DMS (oral aripiprazole + ingestible event marker [IEM], IEM-detecting skin patch, and software application). Integrated call-center functionality was assessed based on numbers and types of calls. Ingestion adherence with prescribed treatment (aripiprazole + IEM) during good patch wear and proportion of time with good patch wear (days with ≥80% patch data or detected IEM) were also assessed. Results: All enrolled patients (n=49) used the DMS and were included in analyses; disease duration overall approached 10 years. For a duration of 8 weeks, 136 calls were made by patients, and a comparable 160 calls were made to patients, demonstrating interactive communication. The mean (SD) number of calls made by patients was 2.8 (3.5). Approximately half of the inbound calls made by patients occurred during the first 2 weeks and were software application- or patch-related. Mean ingestion adherence was 88.6%, and corresponding good patch wear occurred on 80.1% of study days. Conclusion: In this pilot study, the integrated call center facilitated DMS implementation in patients with SMI on stable doses of oral aripiprazole. In clinical practice, the call center and the DMS will facilitate objective measurement of adherence and potentially improve rates of adherence in patients with SMI. Keywords: schizophrenia, bipolar I disorder, major depressive disorder, digital medicine, adherence Kopelowicz ABaker RAZhao CBrewer CLawson EPeters-Strickland TDove Medical Pressarticleschizophreniabipolar I disordermajor depressive disorderdigital medicineadherenceNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 13, Pp 2641-2651 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	schizophrenia bipolar I disorder major depressive disorder digital medicine adherence Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	schizophrenia bipolar I disorder major depressive disorder digital medicine adherence Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Kopelowicz A Baker RA Zhao C Brewer C Lawson E Peters-Strickland T A multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness
description	Alex Kopelowicz,1 Ross A Baker,2 Cathy Zhao,2 Claudette Brewer,3 Erica Lawson,3 Timothy Peters-Strickland2 1David Geffen School of Medicine, University of California, Los Angeles, CA, 2Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, 3Otsuka Pharmaceutical Development and Commercialization Inc., Rockville, MD, USA Background: Medication nonadherence is common in the treatment of serious mental illness (SMI) and leads to poor outcomes. The digital medicine system (DMS) objectively measures adherence with oral aripiprazole in near-real time, allowing recognition of adherence issues. This pilot study evaluated the functionality of an integrated call center in optimizing the use of the DMS. Materials and methods: An 8-week, open-label, single-arm trial at four US sites enrolled adults with bipolar I disorder, major depressive disorder, and schizophrenia on stable oral aripiprazole doses and willing to use the DMS (oral aripiprazole + ingestible event marker [IEM], IEM-detecting skin patch, and software application). Integrated call-center functionality was assessed based on numbers and types of calls. Ingestion adherence with prescribed treatment (aripiprazole + IEM) during good patch wear and proportion of time with good patch wear (days with ≥80% patch data or detected IEM) were also assessed. Results: All enrolled patients (n=49) used the DMS and were included in analyses; disease duration overall approached 10 years. For a duration of 8 weeks, 136 calls were made by patients, and a comparable 160 calls were made to patients, demonstrating interactive communication. The mean (SD) number of calls made by patients was 2.8 (3.5). Approximately half of the inbound calls made by patients occurred during the first 2 weeks and were software application- or patch-related. Mean ingestion adherence was 88.6%, and corresponding good patch wear occurred on 80.1% of study days. Conclusion: In this pilot study, the integrated call center facilitated DMS implementation in patients with SMI on stable doses of oral aripiprazole. In clinical practice, the call center and the DMS will facilitate objective measurement of adherence and potentially improve rates of adherence in patients with SMI. Keywords: schizophrenia, bipolar I disorder, major depressive disorder, digital medicine, adherence
format	article
author	Kopelowicz A Baker RA Zhao C Brewer C Lawson E Peters-Strickland T
author_facet	Kopelowicz A Baker RA Zhao C Brewer C Lawson E Peters-Strickland T
author_sort	Kopelowicz A
title	A multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness
title_short	A multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness
title_full	A multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness
title_fullStr	A multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness
title_full_unstemmed	A multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness
title_sort	multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/1ca2a42b126d4ded8b8cb9eb22224a61
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A multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness

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