Electronic Monitoring and Improvement of Adherence to Direct Oral Anticoagulant Treatment - a Randomised Crossover Study of an Educational and Reminder-based Intervention in Ischaemic Stroke Patients Under Polypharmacy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Change of non-optimal timing adherence to DOACs
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1
Intake reminders followed by crossover to no intake reminders
Intervention: Medication intake reminders (Behavioral)
Group 1
Intake reminders followed by crossover to no intake reminders
Intervention: Pillbox use and counselling (Behavioral)
Group 2
No intake reminders followed by crossover to intake reminders
Intervention: Medication intake reminders (Behavioral)
Group 2
No intake reminders followed by crossover to intake reminders
Intervention: Pillbox use and counselling (Behavioral)
Outcomes
Primary Outcomes
Change of non-optimal timing adherence to DOACs
Time Frame: 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 Outcomes
- Self-reported adherence to DOACs(0 - 6 months)
- Clinical vascular events or death(up to 9 months)
- Change of timing adherence to DOACs(0 - 3 months, 3 - 6 months, 6 - 9 months)
- Change of non-optimal taking 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)