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
Authors Kopelowicz A, Baker RA, Zhao C, Brewer C, Lawson E, Peters-Strickland T
Received 2 June 2017
Accepted for publication 7 August 2017
Published 19 October 2017 Volume 2017:13 Pages 2641—2651
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 4
Editor who approved publication: Dr Roger Pinder
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
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