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Considering a one-sided significance level of 2.5% and a power of 90%, it is necessary to include 137 participants per group (G*Power 3.1). Assuming a 10% drop-out rate, the final estimate is 306 participants in total (or 153 participants per arm).
This trial uses a noninferiority and possibly superiority hypothesis testing framework between groups for primary, secondary, and exploratory outcomes.
JMIR Res Protoc 2025;14:e71326
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With N=280, G*Power calculations [63] show our study would have a 95% chance (with P
Patients will complete surveys at baseline, 6, 12, and 18 months. Baseline surveys were collected at training and setup, and subsequent surveys will be mailed to patients with a return stamped envelope. Participants are encouraged to contact the study staff if questions arise. All 4 surveys will assess primary and secondary outcomes using the measures detailed above.
JMIR Res Protoc 2025;14:e64449
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User interface of Wise App showcasing demo account data: (A) main menu, (B) dashboard with medication adherence status, (C) chat interface, (D) My Stats tab, (E) Videos and Information tab, (F) My Alerts tab, and (G) My Meds tab and Edit Schedule interface.
The Clever Cap pill bottle (Figure 2) tracked medication adherence by recording when the bottle was opened, with a dose marked as “taken” only if the cap remained off for at least 5 seconds.
JMIR Form Res 2025;9:e67997
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