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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
130
Acoustic and visual alarm at predefined DOAC-intake timepoints.
All patients will be counselled based on their previous electronically recorded adherence data and will be given a multicompartment pillbox für daily use
University Hospital Basel
Basel, Switzerland
Change of non-optimal timing adherence to DOACs
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
Time frame: 0 - 3 months, 3 - 6 months, 6 - 9 months
Change of non-optimal taking adherence to DOACs
Non-optimal taking adherence to DOACs is defined as at least one DOAC dose not recorded
Time frame: 0 - 3 months, 3 - 6 months, 6 - 9 months
Change of timing adherence to DOACs
Timing adherence to DOACs is defined as the proportion of prescribed DOAC doses taken within 25% of the prescribed dosing time schedule
Time frame: 0 - 3 months, 3 - 6 months, 6 - 9 months
Change of taking adherence to DOACs
Taking adherence to DOACs is defined as the proportion of prescribed DOAC doses taken.
Time frame: 0 - 3 months, 3 - 6 months, 6 - 9 months
Self-reported adherence to DOACs
Self-reported adherence to DOACs is captured on various questionnaires
Time frame: 0 - 6 months
Clinical vascular events or death
Recurrent ischaemic stroke or TIA, intracranial hemorrhage, major extracranial hemorrhage, myocardial infarction, venous thromboembolism and death
Time frame: up to 9 months
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