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Protocol for MAAESTRO: Electronic Monitoring and Improvement of Adherence to Direct Oral Anticoagulant Treatment-A Randomized Crossover Study of an Educational and Reminder-Based Intervention in Ischemic Stroke Patients Under Polypharmacy

Polymeris, Alexandros A. and Albert, Valerie and Hersberger, Kurt E. and Engelter, Stefan T. and Schaedelin, Sabine and Arnet, Isabelle and Lyrer, Philippe A.. (2018) Protocol for MAAESTRO: Electronic Monitoring and Improvement of Adherence to Direct Oral Anticoagulant Treatment-A Randomized Crossover Study of an Educational and Reminder-Based Intervention in Ischemic Stroke Patients Under Polypharmacy. Frontiers in Neurology, 9. p. 1134.

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Official URL: https://edoc.unibas.ch/74559/

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Abstract

Background: Non-adherence to direct oral anticoagulants (DOACs) remains a matter of concern, especially for patients with a recent stroke. However, data on electronically monitored adherence and adherence-improving interventions are scarce. Aims: We aim to use electronic monitoring in DOAC-treated stroke patients to (i) evaluate the effect of an educational, reminder-based adherence-improving intervention, (ii) investigate predictors of non-adherence, (iii) identify reliable self-report measures of adherence, and (iv) explore the association of non-adherence with clinical outcomes. Methods: Single-center, randomized, crossover, open-label study. Adherence to DOACs of polymedicated patients self-administering their medication will be monitored electronically throughout the 12-month-long study following hospitalization for ischemic stroke. After a 6-month observational phase, patients will receive pharmaceutical counseling with feedback on their intake history and be given a multi-compartment pillbox for the subsequent 6-month interventional phase. The pillbox will provide intake reminders either during the first or the last three interventional-phase months. Patients will be randomly allocated to reminders-first or reminders-last. Study outcomes: Primary: non-optimal timing adherence; Secondary: non-optimal taking adherence; timing adherence; taking adherence; self-reported adherence; clinical outcomes including ischemic and hemorrhagic events; patient-reported device usability and satisfaction. Sample size estimates: A sample of 130 patients provides 90% power to show a 20% improvement of the primary adherence outcome with intake reminders. Discussion: MAAESTRO will investigate various aspects of non-adherence and evaluate the effect of an adherence-improving intervention in DOAC-treated patients with a recent stroke using electronic monitoring. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03344146, Swiss National Clinical Trials Portal SNCTP000002410.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Pharmaceutical Care (Hersberger)
UniBasel Contributors:Arnet, Isabelle and Polymeris, Alexandros and Albert, Valerie and Hersberger, Kurt E. and Engelter, Stefan and Lyrer, Philippe A. and Sch├Ądelin, Sabine
Item Type:Article, refereed
Article Subtype:Further Journal Contribution
ISSN:1664-2295
Note:Publication type according to Uni Basel Research Database: Journal item
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Last Modified:02 Apr 2020 17:28
Deposited On:02 Apr 2020 17:28

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