NCT03344146

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-12-01
• Primary completion: 2022-03-14
• Completion: 2022-03-14
• First posted: 2017-11-17
• Last updated: 2022-12-21

Locations

1 site across 1 country: Switzerland