Dataset Information

Long-Term Stability of the Electronic Sensor Component of a Digital Pill System in Real-World Storage Settings.

ABSTRACT: Background: Digital pill systems comprise an ingestible sensor integrated into a gelatin capsule that overencapsulates medication allowing real-time measures of medication ingestion. These systems may improve the manner in which medication adherence can be assessed and supported. Objective: In this investigation, we tested the durability of the ingestible sensor as part of a clinical trial to measure the feasibility and acceptability of the system to measure adherence to once daily tenofovir disoproxil fumarate/emtricitabine (NCT03842436). Methods: Digital pills not dispensed during the study were stored in a pharmacy. Seventeen sensors were selected from digital pills stored for at least 12 months and activated in a simulated gastric environment. A radiofrequency spectrum analyzer and the reader device used in the clinical trial to capture ingestion events were used to measure activation of emitters. A passing evaluation was defined as an energized emitter within 30 minutes of immersion, ability to broadcast a signal for 10 minutes, and successful acquisition by the reader. Results: All ingestible sensors passed the stability test. Mean activation time in simulated gastric fluid was 3.33 minutes (SD = 1.47); emitters remained active for a mean of 47.72 minutes (SD = 1.78). These parameters matched guidelines defined in the ID-Cap system requirements for use in patients. Conclusions: Ingestible sensor components of the ID-Cap system were therefore stable after long-term storage.

SUBMITTER: Chai PR

PROVIDER: S-EPMC8113663 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Long-Term Stability of the Electronic Sensor Component of a Digital Pill System in Real-World Storage Settings.

Chai Peter R PR Goodman Georgia G Bustamante Majo J MJ Mohamed Yassir Y Castillo-Mancilla Jose J Boyer Edward W EW Mayer Kenneth H KH Rosen Rochelle K RK Baumgartner Susan L SL Buffkin Eric E O'Cleirigh Conall C

The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians 20210106 3

<b>Background:</b> Digital pill systems comprise an ingestible sensor integrated into a gelatin capsule that overencapsulates medication allowing real-time measures of medication ingestion. These systems may improve the manner in which medication adherence can be assessed and supported. <b>Objective:</b> In this investigation, we tested the durability of the ingestible sensor as part of a clinical trial to measure the feasibility and acceptability of the system to measure adherence to once daily ...[more]

PMID: 34752557

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Project description:BackgroundIn most controlled studies of multi-component cognitive intervention, participants' cognitive levels are homogenous, which is contrary to real-world settings. There is a lack of research studying the implementation of evidence-based cognitive intervention in communities. This study describes the implementation and preliminary effectiveness of a Multi-component Cognitive Intervention using Simulated Everyday Tasks (MCI-SET) for older adults with different cognitive levels in real-world settings.MethodsSingle group, pre-intervention assessment, post-intervention assessment, and 3-month follow-up research design. MCI-SET consists of 12 two-hour weekly sessions that include motor-cognitive tasks, cognitive training, and cognitive rehabilitation. One hundred and thirty participants, > = 65 and frail, dependence on > = one instrumental daily activity, or with confirmed dementia, from eight community centers were included. The primary outcome is general cognition (Montreal Cognitive Assessment-Taiwan, MoCA-T). Secondary outcomes are memory (Miami Prospective Memory Test, Digits Forward, Digits Backward), attention (Color Trail Test-Part 1), executive function (Color Trail Test-Part 2), and general function (Kihon Checklist-Taiwan).ResultsPre-intervention workshop for group leaders, standardized activity protocols, on-site observation, and ten weekly conferences were conducted to ensure implementation fidelity. MCI-SET had an 85% retention rate and 96% attendance rate. The participants had a mean age of 78.26 ± 7.00 and a mean MoCA-T score of 12.55 ± 7.43. 73% were female. General cognition (Hedges' g = 0.31), attention (Hedges' g = 0.23), and general function (Hedges' g = 0.31), showed significant post-intervention improvement with small effect size. Follow-ups showed maintained improvement in general cognition (Hedges' g = 0.33), and delayed effect on attention (Hedges' g = 0.20), short-term memory (Hedges' g = 0.38), and executive function (Hedges' g = 0.40). Regression analysis indicated that the intervention settings (day care centers vs neighborhood centers), the pre-intervention cognitive levels, and the pre-intervention general function of the participants were not associated with the outcomes.ConclusionsMCI-SET is feasible and can improve the cognitive skills and general functions of older adults with heterogeneous cognitive skills or disabilities. It is essential to tailor programs to fit the interests of the participants and the culture of local communities. Group leaders must also have the skills to adjust the cognitive demands of the tasks to meet the heterogeneous cognitive levels of participants.Trial registrationThis study was retrospectively registered at clinicaltrials.gov (Identifier: NCT04615169 ).

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Long-Term Stability of the Electronic Sensor Component of a Digital Pill System in Real-World Storage Settings.

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Long-Term Stability of the Electronic Sensor Component of a Digital Pill System in Real-World Storage Settings.

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