Trial reportNeuropsychiatric disease and treatment2021
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.
Trial report in Neuropsychiatric disease and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03568500 (A Multicentre, 8-week, Single-arm, Open-label, Pragmatic Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adult Subjects With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic), which is not on this map. Cited by 11 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicentre, 8-week, Single-arm, Open-label, Pragmatic Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adult Subjects With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic (Aripiprazole, Olanzapine, Quetiapine, or Risperidone)
Who cites it
11 citing papers in PubMed.
- Smartphone Apps and Digital Tools for Managing Schizophrenia and Psychotic Disorders: A Clinical Review.Focus (American Psychiatric Publishing) · 2025Review
- Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders.NPJ digital medicine · 2025Article
- A systematic review of passive data for remote monitoring in psychosis and schizophrenia.NPJ digital medicine · 2025Article
- User Experience of Persons Using Ingestible Sensor-Enabled Pre-Exposure Prophylaxis to Prevent HIV Infection: Cross-Sectional Survey Study.JMIR mHealth and uHealth · 2024Article
- Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials.JMIR formative research · 2023Article
- Digital health interventions to improve adherence to oral antipsychotics among patients with schizophrenia: a scoping review.BMJ open · 2023Article
- Real-World Evidence of Aripiprazole Tablets with Sensor: Treatment Patterns and Impacts on Psychiatric Healthcare Resource Utilization.ClinicoEconomics and outcomes research : CEOR · 2023Article
- Bibliometric analysis and evidence of clinical efficacy and safety of digital pills.Frontiers in pharmacology · 2023Review
- Digital Medicine System in Veterans With Severe Mental Illness: Feasibility and Acceptability Study.JMIR formative research · 2022Article
- Use of an Ingestible, Sensor-Based Digital Adherence System to Strengthen the Therapeutic Relationship in Serious Mental Illness.JMIR mental health · 2022Article
- Healthcare Provider Engagement with a Novel Dashboard for Tracking Medication Ingestion: Impact on Treatment Decisions and Clinical Assessments for Adults with Schizophrenia.Neuropsychiatric disease and treatment · 2022Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
purposeSymptoms 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.
methodsThis was an 8-week open-label, single-arm, multicenter, Phase 4 pragmatic study (NCT03568500; 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).
resultsFrom 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.
conclusionThe DMS had sufficient performance in, and acceptance from, subjects with psychotic disorders and was generally well tolerated.
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