Hummingbird Study: Results from an Exploratory Trial Assessing the Performance and Acceptance of a Digital Medicine System in Adults with Schizophrenia, Schizoaffective Disorder, or First-Episode Psychosis

J Corey Fowler,1 Nathan Cope,2 Jonathan Knights,3 Hui Fang,4 Taisa Skubiak,5 Sukhi S Shergill,6 Peter Phiri,7 Shanaya Rathod,7 Timothy Peters-Strickland1 1Global Clinical Development, CNS and Digital Medicine, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540,...

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Autores principales:	Fowler JC, Cope N, Knights J, Fang H, Skubiak T, Shergill SS, Phiri P, Rathod S, Peters-Strickland T
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	digital medicine antipsychotic digital health medication adherence Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/4dda4de0462242109b2ee8e4eaf7b303
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spelling	oai:doaj.org-article:4dda4de0462242109b2ee8e4eaf7b3032021-12-02T14:14:59ZHummingbird Study: Results from an Exploratory Trial Assessing the Performance and Acceptance of a Digital Medicine System in Adults with Schizophrenia, Schizoaffective Disorder, or First-Episode Psychosis1178-2021https://doaj.org/article/4dda4de0462242109b2ee8e4eaf7b3032021-02-01T00:00:00Zhttps://www.dovepress.com/hummingbird-study-results-from-an-exploratory-trial-assessing-the-perf-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021J Corey Fowler,1 Nathan Cope,2 Jonathan Knights,3 Hui Fang,4 Taisa Skubiak,5 Sukhi S Shergill,6 Peter Phiri,7 Shanaya Rathod,7 Timothy Peters-Strickland1 1Global Clinical Development, CNS and Digital Medicine, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 2Program Management, Otsuka Pharmaceutical Europe Ltd., Wexham, SL3 6PJ, UK; 3Data Insights and Analytics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 4Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 5Clinical Management, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 6Institute of Psychiatry, Psychology and Neuroscience, King’s College London and South London and Maudsley NHS Foundation Trust, London, SE5 8AF, UK; 7Southern Health NHS Foundation Trust, Moorgreen Hospital, Clinical Trials Facility, Research Department, Southampton, SO30 3JB, UKCorrespondence: J Corey FowlerOtsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ, 08540, USATel +1 919 475 4823Email corey.fowler@otsuka-us.comPurpose: Symptoms of psychotic disorders can complicate efforts to accurately evaluate patients’ medication ingestion. The digital medicine system (DMS), composed of antipsychotic medication co-encapsulated with an ingestible sensor, wearable sensor patches, and a smartphone application, was developed to objectively measure medication ingestion. We assessed performance and acceptance of the DMS in subjects with psychotic disorders.Methods: This was an 8-week open-label, single-arm, multicenter, Phase 4 pragmatic study (NCT 03568500; EudraCT #2017-004602-17). Eligible adults were diagnosed with schizophrenia, schizoaffective disorder, or first-episode psychosis; were receiving aripiprazole, quetiapine, olanzapine, or risperidone; and could use the DMS with the application downloaded on a personal smartphone. The primary endpoint was good patch coverage, defined as the proportion of days over the assessment period where ≥ 80.0% of patch data was available, or an ingestion was detected. Exploratory endpoints included a survey on user satisfaction, used to assess acceptance of the DMS. Safety analyses included the incidence of treatment-emergent adverse events (TEAEs).Results: From May 25, 2018 to March 22, 2019, 55 subjects were screened and 44 were enrolled. Good patch coverage was achieved on 63.4% of days assessed and the DMS generated an adherence metric of ≥ 80.0%, reflecting the percentage of ingestion events expected when good patch coverage was reported. Most subjects (53.5%) were satisfied with the DMS. Medical device skin irritations were the only TEAEs reported.Conclusion: The DMS had sufficient performance in, and acceptance from, subjects with psychotic disorders and was generally well tolerated.Keywords: digital medicine, antipsychotic, digital health, medication adherenceFowler JCCope NKnights JFang HSkubiak TShergill SSPhiri PRathod SPeters-Strickland TDove Medical Pressarticledigital medicineantipsychoticdigital healthmedication adherenceNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 17, Pp 483-492 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	digital medicine antipsychotic digital health medication adherence Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	digital medicine antipsychotic digital health medication adherence Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Fowler JC Cope N Knights J Fang H Skubiak T Shergill SS Phiri P Rathod S Peters-Strickland T Hummingbird Study: Results from an Exploratory Trial Assessing the Performance and Acceptance of a Digital Medicine System in Adults with Schizophrenia, Schizoaffective Disorder, or First-Episode Psychosis
description	J Corey Fowler,1 Nathan Cope,2 Jonathan Knights,3 Hui Fang,4 Taisa Skubiak,5 Sukhi S Shergill,6 Peter Phiri,7 Shanaya Rathod,7 Timothy Peters-Strickland1 1Global Clinical Development, CNS and Digital Medicine, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 2Program Management, Otsuka Pharmaceutical Europe Ltd., Wexham, SL3 6PJ, UK; 3Data Insights and Analytics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 4Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 5Clinical Management, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 08540, USA; 6Institute of Psychiatry, Psychology and Neuroscience, King’s College London and South London and Maudsley NHS Foundation Trust, London, SE5 8AF, UK; 7Southern Health NHS Foundation Trust, Moorgreen Hospital, Clinical Trials Facility, Research Department, Southampton, SO30 3JB, UKCorrespondence: J Corey FowlerOtsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ, 08540, USATel +1 919 475 4823Email corey.fowler@otsuka-us.comPurpose: Symptoms of psychotic disorders can complicate efforts to accurately evaluate patients’ medication ingestion. The digital medicine system (DMS), composed of antipsychotic medication co-encapsulated with an ingestible sensor, wearable sensor patches, and a smartphone application, was developed to objectively measure medication ingestion. We assessed performance and acceptance of the DMS in subjects with psychotic disorders.Methods: This was an 8-week open-label, single-arm, multicenter, Phase 4 pragmatic study (NCT 03568500; EudraCT #2017-004602-17). Eligible adults were diagnosed with schizophrenia, schizoaffective disorder, or first-episode psychosis; were receiving aripiprazole, quetiapine, olanzapine, or risperidone; and could use the DMS with the application downloaded on a personal smartphone. The primary endpoint was good patch coverage, defined as the proportion of days over the assessment period where ≥ 80.0% of patch data was available, or an ingestion was detected. Exploratory endpoints included a survey on user satisfaction, used to assess acceptance of the DMS. Safety analyses included the incidence of treatment-emergent adverse events (TEAEs).Results: From May 25, 2018 to March 22, 2019, 55 subjects were screened and 44 were enrolled. Good patch coverage was achieved on 63.4% of days assessed and the DMS generated an adherence metric of ≥ 80.0%, reflecting the percentage of ingestion events expected when good patch coverage was reported. Most subjects (53.5%) were satisfied with the DMS. Medical device skin irritations were the only TEAEs reported.Conclusion: The DMS had sufficient performance in, and acceptance from, subjects with psychotic disorders and was generally well tolerated.Keywords: digital medicine, antipsychotic, digital health, medication adherence
format	article
author	Fowler JC Cope N Knights J Fang H Skubiak T Shergill SS Phiri P Rathod S Peters-Strickland T
author_facet	Fowler JC Cope N Knights J Fang H Skubiak T Shergill SS Phiri P Rathod S Peters-Strickland T
author_sort	Fowler JC
title	Hummingbird Study: Results from an Exploratory Trial Assessing the Performance and Acceptance of a Digital Medicine System in Adults with Schizophrenia, Schizoaffective Disorder, or First-Episode Psychosis
title_short	Hummingbird Study: Results from an Exploratory Trial Assessing the Performance and Acceptance of a Digital Medicine System in Adults with Schizophrenia, Schizoaffective Disorder, or First-Episode Psychosis
title_full	Hummingbird Study: Results from an Exploratory Trial Assessing the Performance and Acceptance of a Digital Medicine System in Adults with Schizophrenia, Schizoaffective Disorder, or First-Episode Psychosis
title_fullStr	Hummingbird Study: Results from an Exploratory Trial Assessing the Performance and Acceptance of a Digital Medicine System in Adults with Schizophrenia, Schizoaffective Disorder, or First-Episode Psychosis
title_full_unstemmed	Hummingbird Study: Results from an Exploratory Trial Assessing the Performance and Acceptance of a Digital Medicine System in Adults with Schizophrenia, Schizoaffective Disorder, or First-Episode Psychosis
title_sort	hummingbird study: results from an exploratory trial assessing the performance and acceptance of a digital medicine system in adults with schizophrenia, schizoaffective disorder, or first-episode psychosis
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/4dda4de0462242109b2ee8e4eaf7b303
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Hummingbird Study: Results from an Exploratory Trial Assessing the Performance and Acceptance of a Digital Medicine System in Adults with Schizophrenia, Schizoaffective Disorder, or First-Episode Psychosis

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