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Adherence, PatientMAAESTRONCT03344146

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

A study testing Medication intake reminders and Pillbox use and counselling in people with Adherence, Patient and Stroke, Ischemic, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adherence, Patient, Stroke, Ischemic
What is being tested?
Medication intake reminders and Pillbox use and counselling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteSwitzerland
Study dates
1 Dec 2017to 14 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Basel

    Basel, 4031

Other trials in Switzerland

About this study

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

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.

Being tested
Medication intake reminders, Pillbox use and counselling
Keywords
ischemic stroke, direct oral anticoagulants, adherence, electronic monitoring, adherence-improving intervention, polypharmacy
Medical subject headings
Patient Compliance, Ischemic Stroke, Adherence Interventions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medication intake remindersBehavioural

    Acoustic and visual alarm at predefined DOAC-intake timepoints.

  • Pillbox use and counsellingBehavioural

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

Study groups in NCT03344146
Study groupRoleWhat they receive
Group 1OtherIntake reminders followed by crossover to no intake reminders
Receives: Behavioral: Medication intake reminders; Behavioral: Pillbox use and counselling
Group 2OtherNo intake reminders followed by crossover to intake reminders
Receives: Behavioral: Medication intake reminders; Behavioral: Pillbox use and counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 0 - 3 months, 3 - 6 months, 6 - 9 months

Secondary outcomes (5)

  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

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start1 Dec 2017
  3. Primary completion14 Mar 2022
  4. Study completion14 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03344146
Sponsor's protocol ID
me17Lyrer2
Acronym
MAAESTRO
Status last verified
Dec 2022
First submitted
9 Nov 2017
Last updated
21 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38662779

  • 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.

    PubMed 37831125

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Medication intake reminders and Pillbox use and counselling in people with Adherence, Patient and Stroke, Ischemic, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of non-optimal timing adherence to DOACs (time frame: 0 - 3 months, 3 - 6 months, 6 - 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03344146, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.

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