Hummingbird Study: a study protocol for a multicentre exploratory trial to assess the acceptance and performance of a digital medicine system in adults with schizophrenia, schizoaffective disorder or first-episode psychosis

Fowler, Jamie; Cope, Nathan; Knights, Jonathan; Phiri, Peter; Makin, Andrew; Peters-Strickland, Tim; Rathod, Shanaya

doi:10.1136/bmjopen-2018-025952

Cited by 12 publications

(16 citation statements)

References 33 publications

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“…Nascent multimodal sensing approaches, combining wearable devices, smartphone apps and web platforms, have also been deployed to monitor adherence to medications. One such multimodal digital monitoring system is Abilify MyCite (Fowler et al, 2019; Kane et al, 2013; Peters-Strickland et al, 2016, 2018; Rohatagi et al, 2016). Abilify MyCite is approved in the United States by the Food and Drug Administration (FDA) for the same indications as the antipsychotic aripiprazole (Abilify), but has been the focus of debate.…”

Section: Resultsmentioning

confidence: 99%

mHealth for schizophrenia spectrum disorders management: A systematic review

Chivilgina

Wangmo

Elger

et al. 2020

Int J Soc Psychiatry

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Background: Various types of computational technologies can be used to access, store and wirelessly share private and sensitive user-related information. The ‘big data’ provided by these technologies may enable researchers and clinicians to better identify behavioral patterns and to provide a more personalized approach to care. The information collected, however, can be misused or potentially abused, and therefore could be detrimental to the very people who provided their medical data with the hope of improving care. This article focuses on the use of emerging mobile technologies that allow the collection of data about patients experiencing schizophrenia spectrum and related disorders. Schizophrenia has been recognized by the Sustainable Development Goals of the United Nations for its burden on our health care system and society [1]. Our analysis provides an overview of the range of available mobile technologies for people with schizophrenia and related conditions along with the technology’s reported capabilities and limitations, and efficacy of mHealth interventions based on the data from articles. Thus, the focus of this review is first and foremost to update the scope of existing technologies as previous systematic reviews such as the ones by Alvarez-Jimenez et al. and by Firth and Torous are outdated [2, 3]. Although we also examine the ethical issues arising from the use of these technologies, for an in-depth analysis of the ethical implications of mobile Health technologies (mHealth), we refer the readers to our follow-up article. In terms of the ubiquitous availability of technology on the internet, our article summarizes significant information for mental health specialists and apprises the reader about the existence of these technologies. Objectives: In terms of the ubiquitous availability of technology on the internet, our article summarizes significant information for mental health specialists and apprises the reader about the existence of these technologies.

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Section: Resultsmentioning

confidence: 99%

mHealth for schizophrenia spectrum disorders management: A systematic review

Chivilgina

Wangmo

Elger

et al. 2020

Int J Soc Psychiatry

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“…The digital medicine system (DMS) measures ingestion of a medication using an ingestible sensor that is either embedded within a tablet 14 , 15 or embedded within an inert tablet and co-encapsulated with an oral medication tablet. 16 After ingestion of the tablet, the sensor is activated by stomach fluid and sends a signal to a wearable sensor patch attached to the patient’s torso. 16 A smartphone application collects these data from the patch via Bluetooth and transfers them to a secure digital health data server.…”

Section: Introductionmentioning

confidence: 99%

“… 16 After ingestion of the tablet, the sensor is activated by stomach fluid and sends a signal to a wearable sensor patch attached to the patient’s torso. 16 A smartphone application collects these data from the patch via Bluetooth and transfers them to a secure digital health data server. 16 The data can be accessed by patients through the smartphone application or by healthcare providers and caregivers through separate web portals.…”

Section: Introductionmentioning

confidence: 99%

“… 16 A smartphone application collects these data from the patch via Bluetooth and transfers them to a secure digital health data server. 16 The data can be accessed by patients through the smartphone application or by healthcare providers and caregivers through separate web portals. 16 The DMS is intended to encourage greater self-management of mental illness by helping the patient and their healthcare provider track their medication-taking behaviors to support informed treatment discussions.…”

Section: Introductionmentioning

confidence: 99%

“… 16 The DMS is intended to encourage greater self-management of mental illness by helping the patient and their healthcare provider track their medication-taking behaviors to support informed treatment discussions. 16 …”

Section: Introductionmentioning

confidence: 99%

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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

Fowler¹,

Cope²,

Knights³

et al. 2021

NDT

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Purpose 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.

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