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

Stroke, Ischemic Clinical Trial

— MAAESTRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344146
• Other study ID #: me17Lyrer2
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: March 14, 2022

Study information

• Verified date: December 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 14, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Behavioral:
• Medication intake reminders
Acoustic and visual alarm at predefined DOAC-intake timepoints.
• 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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Clinical Trial Unit, University Hospital Basel, Switzerland, University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of non-optimal timing adherence to DOACs	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	0 - 3 months, 3 - 6 months, 6 - 9 months
Secondary	Change of non-optimal taking adherence to DOACs	Non-optimal taking adherence to DOACs is defined as at least one DOAC dose not recorded	0 - 3 months, 3 - 6 months, 6 - 9 months
Secondary	Change of timing adherence to DOACs	Timing adherence to DOACs is defined as the proportion of prescribed DOAC doses taken within 25% of the prescribed dosing time schedule	0 - 3 months, 3 - 6 months, 6 - 9 months
Secondary	Change of taking adherence to DOACs	Taking adherence to DOACs is defined as the proportion of prescribed DOAC doses taken.	0 - 3 months, 3 - 6 months, 6 - 9 months
Secondary	Self-reported adherence to DOACs	Self-reported adherence to DOACs is captured on various questionnaires	0 - 6 months
Secondary	Clinical vascular events or death	Recurrent ischaemic stroke or TIA, intracranial hemorrhage, major extracranial hemorrhage, myocardial infarction, venous thromboembolism and death	up to 9 months