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

NCT03344146 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2022-12-21

No results posted yet for this 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.

Conditions

  • Adherence, Patient
  • Stroke, Ischemic

Interventions

BEHAVIORAL

Medication intake reminders

Acoustic and visual alarm at predefined DOAC-intake timepoints.

BEHAVIORAL

Pillbox 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

Sponsors & Collaborators

  • University of Basel

    collaborator OTHER

  • Clinical Trial Unit, University Hospital Basel, Switzerland

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Philippe A Lyrer, MD · University Hospital Basel, Stroke Center and Department of Neurology

  • Kurt Hersberger, MSc, PhD · University of Basel, Department of Pharmaceutical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2022-03-14
Completion
2022-03-14

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344146 on ClinicalTrials.gov