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

NCT03344146 | Completed

• 1 other identifier: me17Lyrer2
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Patient; Stroke, Ischemic

Keywords

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

Outcome Measures

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

  0 - 3 months, 3 - 6 months, 6 - 9 months

Secondary Outcomes (5)

• Change of non-optimal taking adherence to DOACs

  0 - 3 months, 3 - 6 months, 6 - 9 months

• Change of timing adherence to DOACs

  0 - 3 months, 3 - 6 months, 6 - 9 months

• Change of taking adherence to DOACs

  0 - 3 months, 3 - 6 months, 6 - 9 months

• Self-reported adherence to DOACs

  0 - 6 months

• Clinical vascular events or death

  up to 9 months

Study Arms (2)

Group 1

OTHER

Intake reminders followed by crossover to no intake reminders

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

Group 2

OTHER

No intake reminders followed by crossover to intake reminders

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

Interventions

Medication intake reminders BEHAVIORAL

Acoustic and visual alarm at predefined DOAC-intake timepoints.

Group 1; Group 2

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Basel: collaborator
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 38662779 DERIVED

• 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.

  PMID: 37831125 DERIVED

• 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.

  PMID: 34081196 DERIVED

• 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.

  PMID: 33333334 DERIVED

• 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.

  PMID: 30622509 DERIVED

MeSH Terms

Conditions

Patient Compliance; Ischemic Stroke; Adherence Interventions

Interventions

Counseling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Philippe A Lyrer, MD

  University Hospital Basel, Stroke Center and Department of Neurology

  PRINCIPAL INVESTIGATOR

• Kurt Hersberger, MSc, PhD

  University of Basel, Department of Pharmaceutical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: December 1, 2017
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)