Participant Engagement and Symptom Improvement: Aripiprazole Tablets with Sensor for the Treatment of Schizophrenia

Abstract

A recent, phase 3b, mirror-image clinical trial of outpatients with schizophrenia found that use of aripiprazole tablets with sensor (AS; Abilify MyCite ® , comprising an ingestible event-marker sensor embedded in aripiprazole tablets, wearable sensor patches, and a smartphone application) reduced the incidence of psychiatric hospitalizations relative to oral standard-of-care antipsychotics. This analysis explored the relationship between AS engagement by participants and changes in participant performance and symptomseverity measures assessed by clinical raters. Participants and Methods: This post hoc analysis used prospectively collected clinical data from a phase 3b clinical trial (NCT03892889). Outpatients had schizophrenia, were aged 18-65 years, and had ≥ 1 psychiatric hospitalization in the previous 48 months. Participants were grouped by study completion status and a k-means clustering algorithm based on AS utilization, resulting in 3 groups: discontinued (discontinued AS before month 3 of the study); moderate engagement (completed 3 months, used AS intermittently); and high engagement (completed 3 months, used AS regularly). Baseline to end-of-study differences for the Clinical Global Impression Scale (Severity of Illness and Improvement of Illness scales), Personal and Social Performance Scale, and Positive and Negative Syndrome Scale were calculated. Results: A total of 277 outpatients were enrolled (discontinued, n = 164; moderate engagement, n = 63; high engagement, n = 50). All groups experienced symptom improvement from baseline to end-of-study, with significant changes in the more-engaged groups. Highly engaged participants showed significant improvement for all clinical scores and subscores (all P < 0.05) and demonstrated significantly more improvement in symptoms than participants with less engagement. Conclusion: Participants who completed 3 months of the study and had higher AS engagement experienced significantly greater improvement in their end-of-study clinical assessments versus participants who did not complete 3 months. Improvement may be related to more-consistent medication intake and better engagement with a digital health system.

Healthcare Provider Engagement with a Novel Dashboard for Tracking Medication Ingestion: Impact on Treatment Decisions and Clinical Assessments for Adults with Schizophrenia

“…This contrasts with participants’ own reports of usability as reported in a separate post hoc analysis of the primary study, in which only 12% of the participants reported AS at least somewhat difficult to use. 64 This discrepancy in participants’ responses occurred to a similar degree in LDUPs and HDUPs. In our study, 74.0% of the HCPs (both HDUPs and LDUPs) reported that the AS system helped engage study participants in self-management of their condition.…”

Digital health interventions to improve adherence to oral antipsychotics among patients with schizophrenia: a scoping review

“…Most included studies (23 studies) did not report relevant outcomes with psychiatric symptoms as secondary outcomes. Eleven studies reported significantly reduced psychiatric symptoms through interventions,33–35 40 43 48 50–52 55 62 but six studies observed no significant impact in any of the measured symptoms 30 38 44 47 69 70. Three studies found that their interventions significantly enhanced function,43 46 51 but five studies found no difference 31 47 48 52 69.…”

“…The digital medicine system (DMS) is a novel medication adherence assessment device developed to help HCPs evaluate patients’ adherence to antipsychotics 37 55–58 61–63. The wearable sensor patches detect a signal from the ingestible aripiprazole tablets with a sensor integrated into digital medicine and triggered in the stomach after patient consumption.…”

“…Five studies measured adherence using data from electronic or digital devices. In this group, three studies used data from digital technologies to evaluate adherence,57 62 69 and medication event monitoring systems were used in two studies 31 68. Finally, eight studies did not report the measurement tools 37 46 51 56 58 65 66 71…”

“…Most included interventional studies (19 studies) observed that DHIs could significantly improve medication adherence among patients with schizophrenia 29 33 34 38–41 43 45 47 52 54 55 59–61 64 67 69. However, 11 studies found no significant impact in any of the measured adherence outcomes28 30 31 35 36 44 48–50 63 70; the remaining 14 studies reported no relevant adherence-related outcomes 32 37 42 46 51 53 56–58 62 65 66 68 71. In figure 3, evidence of technologies used with reported outcomes of the studies regarding medication adherence is shown.…”