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| Name | Class |
|---|---|
| University of Basel | OTHER |
| Clinical Trial Unit, University Hospital Basel, Switzerland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Intake reminders followed by crossover to no intake reminders |
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| Group 2 | Other | No intake reminders followed by crossover to intake reminders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication intake reminders | Behavioral | Acoustic and visual alarm at predefined DOAC-intake timepoints. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe A Lyrer, MD | University Hospital Basel, Stroke Center and Department of Neurology | Principal Investigator |
| Kurt Hersberger, MSc, PhD | University of Basel, Department of Pharmaceutical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38662779 | Derived | Rekk K, Arnet I, Dietrich F, Polymeris AA, Lyrer PA, Engelter ST, Schaedelin S, Allemann SS. Relationship between electronically monitored adherence to direct oral anticoagulants and ischemic or hemorrhagic events after an initial ischemic stroke-A case control study. PLoS One. 2024 Apr 25;19(4):e0301421. doi: 10.1371/journal.pone.0301421. eCollection 2024. | |
| 37831125 |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D000083242 | Ischemic Stroke |
| D000099060 | Adherence Interventions |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Pillbox use and counselling | Behavioral | All patients will be counselled based on their previous electronically recorded adherence data and will be given a multicompartment pillbox für daily use |
|
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 |
| Dietrich F, Polymeris AA, Albert V, Engelter ST, Hersberger KE, Schaedelin S, Lyrer PA, Arnet I. Intake reminders are effective in enhancing adherence to direct oral anticoagulants in stroke patients: a randomised cross-over trial (MAAESTRO study). J Neurol. 2024 Feb;271(2):841-851. doi: 10.1007/s00415-023-12035-z. Epub 2023 Oct 13. |
| 34081196 | Derived | Dietrich F, Polymeris AA, Verbeek M, Engelter ST, Hersberger KE, Schaedelin S, Arnet I, Lyrer PA. Impact of the COVID-19 lockdown on the adherence of stroke patients to direct oral anticoagulants: a secondary analysis from the MAAESTRO study. J Neurol. 2022 Jan;269(1):19-25. doi: 10.1007/s00415-021-10631-5. Epub 2021 Jun 3. |
| 33333334 | Derived | Albert V, Polymeris AA, Dietrich F, Engelter ST, Hersberger KE, Schaedelin S, Lyrer PA, Arnet I. Insights Into Direct Oral Anticoagulant Therapy Implementation of Stroke Survivors with Atrial Fibrillation in an Ambulatory Setting. J Stroke Cerebrovasc Dis. 2021 Feb;30(2):105530. doi: 10.1016/j.jstrokecerebrovasdis.2020.105530. Epub 2020 Dec 14. |
| 30622509 | Derived | Polymeris AA, Albert V, Hersberger KE, Engelter ST, Schaedelin S, Arnet I, Lyrer PA. 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. Front Neurol. 2018 Dec 21;9:1134. doi: 10.3389/fneur.2018.01134. eCollection 2018. |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D055118 | Medication Adherence |
| D005159 | Health Care Facilities Workforce and Services |