SMAAP-AF study

Not Applicable

• Conditions: on-valvular atrial fibrillation

• Registration Number: JPRN-jRCTs031180142
• Lead Sponsor: Shiga Tsuyoshi

Brief Summary

The characteristics of patients in SMAAP-AF showed that once-daily DOAC tended to have a lower incidence of non-adherence compared to twice-daily DOAC. The SMAAP-AF trial did not find any additional benefits from an educational intervention in improving medication adherence in non-valvular atrial fibrillation patients receiving DOACs. However, educational intervention may improve medication adherence in male patients who are treated with twice-daily DOAC.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-21
• Study Completion: 2019-06-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

1 NVAF patients in outpatient clinics
2 Patients taking edoxaban or apixaban for more than 4 weeks prior to enrolling in this trial
3 In participating in this study, patients who received written consent

Exclusion Criteria

1 Patients participating in or participating in other intervention study or clinical trials
2 Patients who are considered difficult to examine medication adherence
3 Patients requiring family member or others supports with medication management
4 Inpatients
5 Patients were pregnant or expecting to become pregnant within the duration of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence difference estimated by the electronic monitoring device between the observation and intervention periods (each period for 12 weeks)

Secondary Outcome Measures

Name	Time	Method
Adherence estimated by the electronic monitoring device during the observation p3riod (12 weeks)