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Completed

NCT Number: NCT03344146

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

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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Key information

Conditions

Adherence, Patient Adherence Interventions Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Health Behavior Ischemic Stroke Medication Adherence Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Stroke Stroke, Ischemic Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication intake reminders

Behavioral

Acoustic and visual alarm at predefined DOAC-intake timepoints.

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

Primary outcomes

  1. Change of non-optimal timing adherence to DOACs

    Time frame: 0 - 3 months, 3 - 6 months, 6 - 9 months

    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

Secondary outcomes

  1. Change of non-optimal taking adherence to DOACs

    Time frame: 0 - 3 months, 3 - 6 months, 6 - 9 months

    Non-optimal taking adherence to DOACs is defined as at least one DOAC dose not recorded

  2. Change of timing adherence to DOACs

    Time frame: 0 - 3 months, 3 - 6 months, 6 - 9 months

    Timing adherence to DOACs is defined as the proportion of prescribed DOAC doses taken within 25% of the prescribed dosing time schedule

  3. Change of taking adherence to DOACs

    Time frame: 0 - 3 months, 3 - 6 months, 6 - 9 months

    Taking adherence to DOACs is defined as the proportion of prescribed DOAC doses taken.

  4. Self-reported adherence to DOACs

    Time frame: 0 - 6 months

    Self-reported adherence to DOACs is captured on various questionnaires

  5. Clinical vascular events or death

    Time frame: up to 9 months

    Recurrent ischaemic stroke or TIA, intracranial hemorrhage, major extracranial hemorrhage, myocardial infarction, venous thromboembolism and death

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland
  • University of Basel

Registry information

Official study 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

Acronym: MAAESTRO

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2017
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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