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

Polymeris, Alexandros; Albert, Valérie; Hersberger, Kurt E.; Engelter, Stefan T.; Schaedelin, Sabine; Arnet, Isabelle; Lyrer, Philippe

doi:10.3389/fneur.2018.01134

Cited by 7 publications

(17 citation statements)

References 14 publications

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“…The study protocol has been published previously. 19 In brief, AF patients are recruited at the stroke centre of the University Hospital Basel after an ischemic stroke if they are 18 years old, treated with polypharmacy ( 3 medications) including a DOAC that they self-administer. At discharge, patients obtain a small electronic device to record their medication intake.…”

Section: Methodsmentioning

confidence: 99%

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

Albert¹,

Polymeris²,

Dietrich³

et al. 2021

Journal of Stroke and Cerebrovascular Diseases

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Objectives: To describe how stroke survivors with atrial fibrillation implement direct oral anticoagulant treatment and propose appropriate metrics to describe adherence. Materials and Methods: Stroke patients with atrial fibrillation electronically recorded their self-administered direct oral anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban) during a 6-month observation phase after hospitalisation for ischemic stroke. Taking and timing adherence, correct dosing days, drug holidays, time of the day and day of the week subsets, dose-to-dose intervals and longest intervals between two consecutive doses were calculated from electronic monitoring data to describe and discuss the implementation phase of adherence. Results: Data from 41 patients were analysed. Median age was 77 (IQR = 69À84), 63.4% were male and the majority suffered a mild stroke (median NIHSS: 1). Mean taking and timing adherence exceeded 90%. Correct dosing occurred in 86.6% of the days. Seven patients (17.1%) had intake pauses of three or more consecutive days. Patients with twice-daily regimen (70.7%) had higher taking adherence in the morning than in the evening (94.4% versus 89.9%; p = 0.001). No therapy-or anamneses-related characteristic was associated with taking adherence. Conclusions: Although adherence to direct oral anticoagulants of stroke patients with atrial fibrillation exceeded 90%, deviant intake patterns such as drug holidays and missed evening doses were common and raise concerns. Appropriate adherence metrics calculated from electronic monitoring data may guide healthcare professionals elucidating patient-tailored adherence-enhancing interventions. ClinicalTrials.gov registration number: NCT03344146

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Section: Methodsmentioning

confidence: 99%

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

Albert¹,

Polymeris²,

Dietrich³

et al. 2021

Journal of Stroke and Cerebrovascular Diseases

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“…The study includes an initial observational 6-month phase after discharge from the stroke hospitalization. The full study protocol [22] and first results of the observational study phase [23] have been published previously. The MAAESTRO study has been approved by the Ethics Committee of Northwest/Central Switzerland (EKNZ 2017-01552), including the use of study data for further investigations.…”

Section: Study Settingmentioning

confidence: 99%

“…Considering the lack of data on the impact of the COVID-19 pandemic on the adherence of stroke patients to DOACs, we present here for the first time detailed electronic adherence data of DOAC-treated stroke patients from the ongoing MAAESTRO study [22,23], comparing various adherence metrics before and after the imposition of lockdown measures during the first COVID-19 outbreak in Switzerland in March 2020.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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Background The negative impact of the COVID-19 outbreak on stroke care has been reported, but no data exist on the influence of the lockdown on medication adherence to antithrombotic treatment for stroke prevention. We present a comparison of electronic adherence data of stroke patients treated with direct oral anticoagulants (DOAC) prior to and during the COVID-19 lockdown in spring 2020 in Switzerland. Methods This is a secondary analysis using data from the ongoing MAAESTRO study, in which stroke patients with atrial fibrillation electronically monitor their adherence to DOAC treatment. Eligible patients for this analysis had at least four weeks of adherence data prior to and during the COVID-19 lockdown. Three adherence metrics (taking adherence, timing adherence, drug holidays) were calculated and compared descriptively. Results The analysis included eight patients (median age 81.5 years, IQR 74.8–84.5). Five patients had a pre-lockdown taking adherence over 90% (mean 96.8% ± 2.9), with no change during lockdown, high timing adherence in both periods and no drug holidays. The remaining three patients had pre-lockdown taking and timing adherence below 90%. Of those, two patients showed a moderate decline either in taking or timing adherence compared to pre-lockdown. One showed a substantial increase in taking and timing adherence during lockdown (both + 25.8%). Conclusion Our data suggest that a major disruption of social life (i.e., the imposed COVID-19 lockdown) is unlikely to relevantly affect the medication intake behaviour of patients with high pre-established adherence, but might have an impact in patients with previously suboptimal adherence. Trial registration number MAAESTRO: electronic Monitoring and improvement of Adherence to direct oral Anticoagulant treatment—a randomized crossover study of an Educational and reminder-based intervention in ischaemic STROke patients under polypharmacy, NCT03344146.

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“…Thus, we cannot exclude that people will stop practicing the behavior of pressing the button in the long run. However, preliminary data from an ongoing study [18] indicate that monitoring over 12 months is well accepted. Finally, the device itself is unable to tell which medication a patient took if prescribed several, nor it can detect whether a patient took one or several medications.…”

Section: Discussionmentioning

confidence: 99%

“…The cards have been used in a study [18] in Switzerland with a temperate climate. There was no dysfunctioning over the summertime (June-September 2018) due to heat or humidity.…”

Section: Summertime Conditionsmentioning

confidence: 99%

Validation of a Novel Electronic Device for Medication Adherence Monitoring of Ambulatory Patients

2019

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Several methods exist for measuring medication adherence. The Time4MedTM device (Adherence Innovations, Hong Kong) is a small, electronic card to affix on medication packaging that records date and time of intakes when a button is pushed. We aimed to validate the device with an emphasis on polypharmacy. Twenty volunteers used Time4MedTM devices with a virtual thrice daily intake over 14 days. Diary-recorded date and time were compared to electronically-stored events. Functionality, reliability and recovery for different stress conditions were calculated. User‘s acceptability was assessed with the System Usability Scale (SUS). Eleven elderly outpatients (mean age 80.2 ± 8.1 years) taking >3 medications daily used the device over 4 weeks. Volunteers logged 847 events. Functionality (100%), sensitivity (94.9%), specificity (99.4%) and recovery (100%) were high. Dropping the smart card and storing it in a refrigerator caused either the recording of false events or no recording at all. The mean SUS score was 82.6 (SD 14.8), demonstrating excellent acceptability. Satisfaction was very high for volunteers and patients, except for pushing the button. Time4MedTM devices are highly accurate in recording, retaining and delivering electronic data of multiple medication intake. They are well accepted by elderly patients. They can be recommended in clinical studies and for practitioners who desire to elucidate adherence patterns of ambulatory patients.

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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

Cited by 7 publications

References 14 publications

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

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

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

Validation of a Novel Electronic Device for Medication Adherence Monitoring of Ambulatory Patients

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