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

University Hospital Basel

Status: Completed

Conditions: Adherence, Patient; Stroke, Ischemic

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03344146

me17Lyrer2

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Group 1

Other group

Description:

Intake reminders followed by crossover to no intake reminders

Treatment:

Behavioral: Medication intake reminders

Behavioral: Pillbox use and counselling

Group 2

Other group

Description:

No intake reminders followed by crossover to intake reminders

Treatment:

Behavioral: Medication intake reminders

Behavioral: Pillbox use and counselling