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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2022-03-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke

NCT02611440

Ischemic Stroke

UNKNOWN NA

Short Message Service (SMS) Reminders for Stroke Secondary Preventative Medications

NCT02336412

Stroke Ischemic Attack, Transient

COMPLETED NA

ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632

NCT06320431

Acute Ischemic Stroke AIS Stroke Acute Stroke, Acute, Stroke Ischemic

RECRUITING PHASE3

Intravenous Administration of Microplasmin for Treatment of Acute Ischemic Stroke

NCT00123305

Stroke, Acute

COMPLETED PHASE2

Mobile Terminal Based Management of Stroke Secondary Prevention Adminstration Effect Research

NCT02618265

Stroke

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adherence, Patient Stroke, Ischemic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Intake reminders followed by crossover to no intake reminders

Group Type OTHER

Medication intake reminders

Intervention Type BEHAVIORAL

Acoustic and visual alarm at predefined DOAC-intake timepoints.

Pillbox use and counselling

Intervention Type 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 2

No intake reminders followed by crossover to intake reminders

Group Type OTHER

Medication intake reminders

Intervention Type BEHAVIORAL

Acoustic and visual alarm at predefined DOAC-intake timepoints.

Pillbox use and counselling

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Medication intake reminders

Acoustic and visual alarm at predefined DOAC-intake timepoints.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No