ClinicalTrials.gg
CompletedNCT03344146MAAESTROUpdated Dec 21, 2022

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

An interventional study of Medication intake reminders and Pillbox use and counselling in Adherence, Patient and Stroke, Ischemic, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-21.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Health services research

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Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 19 studies in Patient Compliance with a site in Switzerland — 3 open to participants now, 3 under way, none of them phase 3. Patient Compliance · Switzerland.

Enrollment
6th of 14
130 · median 110
Started
2017
with 1 other
No phase
10 of 19
2 open now
Registered
13th of 19
by date
Lead sponsor
2 of 19
University Hospital, Basel, Switzerland

Among the 19 studies in Patient Compliance with a site in Switzerland, this one is the 6th largest by enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2017, is one of 10 with no phase, and was the 13th registered.

Patient Compliance

752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.

Browse Patient Compliance studies →

Open to participants now

3 of the 19 studies in Patient Compliance with a site in Switzerland are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 45 Patient Compliance studies recruiting now, 25 (56%) set no upper age limit and 13 (29%) stop at 75 or younger; 11 take children under 18; 14 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Adherence, Patient
  • Stroke, Ischemic

Keywords

  • ischemic stroke, direct oral anticoagulants, adherence, electronic monitoring, adherence-improving intervention, polypharmacy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed form (ICF)
  • Adult patients (≥ 18 years)
  • Hospitalization for acute ischaemic stroke (including 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

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
130 participants (actual)

Study arms

  • Other
    Group 1

    Intake reminders followed by crossover to no intake reminders

    Behavioral: Medication intake reminders · Behavioral: Pillbox use and counselling

  • Other
    Group 2

    No intake reminders followed by crossover to intake reminders

    Behavioral: Medication intake reminders · Behavioral: Pillbox use and counselling

Interventions

  • BehavioralMedication intake reminders

    Acoustic and visual alarm at predefined DOAC-intake timepoints.

  • BehavioralPillbox use and counselling

    All patients will be counselled based on their previous electronically recorded adherence data and will be given a multicompartment pillbox für daily use

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Self-reported adherence to DOACs

    Self-reported adherence to DOACs is captured on various questionnaires

    Time frame: 0 - 6 months

  5. 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

07

Study locations

1 site
  • University Hospital Basel
    Basel, 4031, Switzerland
08

References and documents

Publications

  • 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. PubMed 34081196 ↗
  • 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. PubMed 33333334 ↗
  • 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. PubMed 30622509 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Mar 2022, 51 months.

Of 224 non-industry interventional studies with no phase under Patient Compliance, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's 51 months is above that.

Counting every sponsor, half of 237 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2017
First posted
Nov 17, 2017
StartActual
Dec 1, 2017
Primary completionActual
Mar 14, 2022
CompletionActual
Mar 14, 2022
Last update
Dec 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03344146
Collaborators
University of Basel, Clinical Trial Unit, University Hospital Basel, Switzerland
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Dec 1, 2017
Primary completion
Mar 14, 2022
Completion
Mar 14, 2022
Last update
Dec 21, 2022

Study contacts

Philippe A Lyrer, MD
principal investigator · University Hospital Basel, Stroke Center and Department of Neurology
Kurt Hersberger, MSc, PhD
principal investigator · University of Basel, Department of Pharmaceutical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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