Clinical trial NCT03344146: Electronic Monitoring and Improvement of Adherence to DOACs in Polymedicated Stroke Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Patient
Stroke, Ischemic
Keywords: ischemic stroke, direct oral anticoagulants, adherence, electronic monitoring, adherence-improving intervention, polypharmacy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Clinical Trial Unit, University Hospital Basel, Switzerland
First posted: 2017-11-17
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of non-optimal timing adherence to DOACs
timeFrame: 0 - 3 months, 3 - 6 months, 6 - 9 months
Secondary outcomes:
measure: Change of non-optimal taking adherence to DOACs
timeFrame: 0 - 3 months, 3 - 6 months, 6 - 9 months
measure: Change of timing adherence to DOACs
timeFrame: 0 - 3 months, 3 - 6 months, 6 - 9 months
measure: Change of taking adherence to DOACs
timeFrame: 0 - 3 months, 3 - 6 months, 6 - 9 months
measure: Self-reported adherence to DOACs
timeFrame: 0 - 6 months
measure: Clinical vascular events or death
timeFrame: up to 9 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital Basel, Stroke Center and Department of Neurology
name: Philippe A Lyrer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Basel, Department of Pharmaceutical Sciences
name: Kurt Hersberger, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.