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

Abstract

Introduction: In patients with schizophrenia, medication adherence is important for relapse prevention, and effective adherence monitoring is essential for treatment planning. A digital medicine system (DMS) has been developed to objectively monitor patient adherence and support clinical decision making regarding treatment choices. This study assesses the acceptance and performance of the DMS in adults with schizophrenia, schizoaffective disorder or first-episode psychosis and in healthcare professionals (HCPs).

Methods/analysis: This is a multicentre, 8-week, single-arm, open-label pragmatic trial designed using coproduction methodology. The study will be conducted at five National Health Service Foundation Trusts in the UK. Patients 18-65 years old with a diagnosis of schizophrenia, schizoaffective disorder or first-episode psychosis will be eligible. HCPs (psychiatrists, care coordinators, nurses, pharmacists), researchers, information governance personnel, clinical commissioning groups and patients participated in the study design and coproduction. Intervention employed will be the DMS, an integrated system comprising an oral sensor tablet coencapsulated with an antipsychotic, non-medicated wearable patch, mobile application (app) and web-based dashboard. The coencapsulation product contains aripiprazole, olanzapine, quetiapine or risperidone, as prescribed by the HCP, with a miniature ingestible event marker (IEM) in tablet. On ingestion, the IEM transmits a signal to the patch, which collects ingestion and physical activity data for processing on the patient's smartphone or tablet before transmission to a cloud-based server for viewing by patients, caregivers and HCPs on secure web portals or mobile apps.

Ethics and dissemination: Approval was granted by London - City and East Research Ethics Committee (REC ref no 18/LO/0128), and clinical trial authorisation was provided by the Medicines and Healthcare products Regulatory Agency. Written informed consent will be obtained from every participant. The trial will be compliant with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines and the Declaration of Helsinki.

Trial registration number: NCT03568500; EudraCT2017-004602-17; Pre-results.

Keywords: coproduction; digital medicine; schizoaffective disorder; schizophrenia.

Conflict of interest statement

Competing interests: JCF, JK and TP-S are employees of Otsuka Pharmaceutical Development & Commercialization. NC is an employee of Otsuka Pharmaceutical Europe. AM is an employee of Otsuka Europe Development and Commercialisation. SR has received honoraria from Otsuka and Lundbeck for educational sessions.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Digital medicine system: coencapsulated antipsychotic medication with miniature ingestible event marker in tablet (MIT) and compatible medical device. Image reprinted from an article in npj Digital Medicine. DM, digital medicine; HCP, healthcare professional.

Figure 2

Description of coproduction workshops with Southern Health NHS Foundation Trust. DMS, digital medicine system; EIP, early intervention in psychosis; IG, information governance; MoSCoW, must have, should have, could have, won’t have; NHS, National Health Service; PANSS, Positive and Negative Syndrome Scale; PPI, patient and public involvement programme.

Figure 3

Study design.