Phase 4
Completed N=44
A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic
Source: ClinicalTrials.gov NCT03568500 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Percentage Of Days With Good Patch Coverage — 64.34; 62.99; 62.51; 63.37 percentage of days
◆ Published Evidence
Emerging
17citations · ~2 / year
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.
Summary
Digital medicine systems (DMS) have been designed to assist individuals with the management of their daily health, wellness, and medication use. The DMS is being developed as a healthcare management tool to precisely measure medication adherence and to potentially enhance adherence.
Linked Publications (2)
-
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.
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Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Of Days With Good Patch Coverage |
64.34; 62.99; 62.51; 63.37 | — |
| SECONDARY Participant Adherence |
88.94; 72.29; 91.04; 86.57 | — |
Eligibility Criteria
Inclusion Criteria
- Participant was prescribed aripiprazole, olanzapine, quetiapine, or risperidone.
- Participant possessed a smartphone, or a smartphone provided by the Sponsor, and was willing to download and interact with the DMS app.
- Skin on the anterior chest just above the lower edge of the rib cage was free of any dermatological problems (for example, open wounds, warts, rashes, atopic dermatitis).
Exclusion Criteria
- Participant with a known allergy to adhesive tape or any pertinent components of the patch or CoE product.
- Prisoners could not be enrolled into this trial.
- Participant who was hospitalized due to mental or physical illness (inpatient) at the time of screening/baseline.
- Any participant who, through religious or lifestyle choices, would not take gelatin capsules.
- Female of childbearing potential who was breast-feeding and/or who had a positive pregnancy test result prior to receiving trial enrollment, or who planned to become pregnancy during the trial.
Data sourced from ClinicalTrials.gov (NCT03568500) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.