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

Conditions

Adherence, Patient, Stroke, Ischemic

Keywords

ischemic stroke, direct oral anticoagulants, adherence, electronic monitoring, adherence-improving intervention, polypharmacy

Brief summary

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.

Katharina Rekk, Isabelle Arnet, Fine Dietrich, Alexandros A. Polymeris, Philippe Lyrer et al. (8 authors)

PLoS ONE2024-04-253 citations

10.1371/journal.pone.0301421

Intake reminders are effective in enhancing adherence to direct oral anticoagulants in stroke patients: a randomised cross-over trial (MAAESTRO study)

Fine Dietrich, Alexandros A. Polymeris, Valérie Albert, Stefan T. Engelter, Kurt E. Hersberger et al. (8 authors)

Journal of Neurology2023-10-137 citations

10.1007/s00415-023-12035-z

Impact of the COVID-19 lockdown on the adherence of stroke patients to direct oral anticoagulants: a secondary analysis from the MAAESTRO study

Fine Dietrich, Alexandros A. Polymeris, Melina Verbeek, Stefan T. Engelter, Kurt E. Hersberger et al. (8 authors)

Journal of Neurology2021-06-0310 citations

10.1007/s00415-021-10631-5

Insights Into Direct Oral Anticoagulant Therapy Implementation of Stroke Survivors with Atrial Fibrillation in an Ambulatory Setting

Valérie Albert, Alexandros A. Polymeris, Fine Dietrich, Stefan T. Engelter, Kurt E. Hersberger et al. (8 authors)

Journal of Stroke and Cerebrovascular Diseases2020-12-1510 citations

10.1016/j.jstrokecerebrovasdis.2020.105530

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

Alexandros A. Polymeris, Valérie Albert, Kurt E. Hersberger, Stefan T. Engelter, Sabine Schaedelin et al. (7 authors)

Frontiers in Neurology2018-12-218 citations

10.3389/fneur.2018.01134

Interventions

BEHAVIORALMedication intake reminders

Acoustic and visual alarm at predefined DOAC-intake timepoints.

BEHAVIORALPillbox use and counselling

All patients will be counselled based on their previous electronically recorded adherence data and will be given a multicompartment pillbox für daily use

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Change of non-optimal timing adherence to DOACs	0 - 3 months, 3 - 6 months, 6 - 9 months	Non-optimal timing adherence is defined as at least one DOAC dose not recorded or recorded outside of 25% of the prescribed dosing time schedule

Secondary

Measure	Time frame	Description
Change of taking adherence to DOACs	0 - 3 months, 3 - 6 months, 6 - 9 months	Taking adherence to DOACs is defined as the proportion of prescribed DOAC doses taken.
Change of non-optimal taking adherence to DOACs	0 - 3 months, 3 - 6 months, 6 - 9 months	Non-optimal taking adherence to DOACs is defined as at least one DOAC dose not recorded
Self-reported adherence to DOACs	0 - 6 months	Self-reported adherence to DOACs is captured on various questionnaires
Change of timing adherence to DOACs	0 - 3 months, 3 - 6 months, 6 - 9 months	Timing adherence to DOACs is defined as the proportion of prescribed DOAC doses taken within 25% of the prescribed dosing time schedule
Clinical vascular events or death	up to 9 months	Recurrent ischaemic stroke or TIA, intracranial hemorrhage, major extracranial hemorrhage, myocardial infarction, venous thromboembolism and death

Countries

Switzerland

Outcome results

None listed