Electronic Monitoring and Improvement of Adherence to DOACs in Polymedicated Stroke Patients

Electronic Monitoring and Improvement of Adherence to Direct Oral Anticoagulant Treatment - a Randomised Crossover Study of an Educational and Reminder-based Intervention in Ischaemic Stroke Patients Under Polypharmacy

Primary objective of the MAAESTRO trial is to evaluate the impact of an educational and reminder-based intervention on the adherence of stroke patients to DOACs. Secondary objectives are to evaluate the association between non-adherence and clinical events, to identify predictors of non-adherence and to compare objective measures of adherence with self-reporting.

Key methodological instrument for this study will be the "Time4Med" pillbox with Smart/ Reminder Card. The study includes 3 visits (baseline visit 0, follow-up visit 1 and end-of-study visit 2) with a total follow-up of 9 months.

After an initial 3-month observational phase with electronic monitoring of adherence using the "Smart Card", all patients will receive counselling based on their electronically recorded drug intake data, as well as a multicompartment pillbox. Patients will be then randomised to one of two groups in a crossover design, so that in the subsequent 6-month interventional phase one group will use a (reminder-delivering) "Reminder Card" for the first 3 months and the "Smart Card" for the last 3 months, while the second group will use the cards in reverse order.

Inclusion Criteria:

• Signed informed consent form (ICF)
• Adult patients (≥ 18 years)
• Hospitalization for acute ischaemic stroke (including TIA with positive neuroimaging)
• DOAC treatment for atrial fibrillation or embolic stroke of undetermined source
• Patients receiving polypharmacy, defined as at least 3 drugs (including DOAC treatment)
• Patients self-administering their medication
• Patients already using a pillbox or willing to use one

Exclusion Criteria:

• Patients not able or unwilling to sign ICF
• Medication administration by caregiver - Filling of the pillbox by a pharmacy, relatives or other caregivers does not exclude the patients, provided that they self-administer their medication
• Patients who are, in the opinion of the investigator, unlikely to adhere to the study schedule or are unsuitable for any other reason