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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adherence, Patient, Stroke, Ischemic

Intervention / Treatment
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* Behavioral: Medication intake reminders
* Behavioral: Pillbox use and counselling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Intake reminders followed by crossover to no intake reminders | Behavioral: Medication intake reminders<br>* Acoustic and visual alarm at predefined DOAC-intake timepoints.<br>Behavioral: Pillbox use and counselling<br>* All patients will be counselled based on their previous electronically recorded adherence data and will be given a multicompartment pillbox für daily use<br>|
| Other: Group 2<br>No intake reminders followed by crossover to intake reminders | Behavioral: Medication intake reminders<br>* Acoustic and visual alarm at predefined DOAC-intake timepoints.<br>Behavioral: Pillbox use and counselling<br>* All patients will be counselled based on their previous electronically recorded adherence data and will be given a multicompartment pillbox für daily use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0 - 3 months, 3 - 6 months, 6 - 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of non-optimal taking adherence to DOACs | Non-optimal taking adherence to DOACs is defined as at least one DOAC dose not recorded | 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 | 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. | 0 - 3 months, 3 - 6 months, 6 - 9 months | 
| Self-reported adherence to DOACs | Self-reported adherence to DOACs is captured on various questionnaires | 0 - 6 months | 
| Clinical vascular events or death | Recurrent ischaemic stroke or TIA, intracranial hemorrhage, major extracranial hemorrhage, myocardial infarction, venous thromboembolism and death | up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, direct oral anticoagulants, adherence, electronic monitoring, adherence-improving intervention, polypharmacy