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

Not Applicable

Completed

• Conditions: Adherence, Patient; Stroke, Ischemic
• Interventions: Behavioral: Medication intake reminders; Behavioral: Pillbox use and counselling

• Registration Number: NCT03344146
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Study Start: 2017-12-01
• Primary Completion: 2022-03-14
• Study Completion: 2022-03-14
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	Medication intake reminders	No intake reminders followed by crossover to intake reminders
Group 1	Medication intake reminders	Intake reminders followed by crossover to no intake reminders
Group 1	Pillbox use and counselling	Intake reminders followed by crossover to no intake reminders
Group 2	Pillbox use and counselling	No intake reminders followed by crossover to intake reminders

Primary Outcome Measures

Name	Time	Method
Change of non-optimal timing adherence to DOACs	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 Outcome Measures

Name	Time	Method
Change of timing adherence to DOACs	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
Change of non-optimal taking adherence to DOACs	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
Self-reported adherence to DOACs	0 - 6 months	Self-reported adherence to DOACs is captured on various questionnaires
Change of taking adherence to DOACs	0 - 3 months, 3 - 6 months, 6 - 9 months	Taking adherence to DOACs is defined as the proportion of prescribed DOAC doses taken.
Clinical vascular events or death	up to 9 months	Recurrent ischaemic stroke or TIA, intracranial hemorrhage, major extracranial hemorrhage, myocardial infarction, venous thromboembolism and death

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland