Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

smartADHERE - Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996435
• Other study ID #: CR108260
• Secondary ID: 39039039AFL4010
• Status: Completed
• Phase: Phase 4
• Start date: December 21, 2016
• Est. completion date: March 22, 2018

Study information

• Verified date: October 2018
• Source: Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the effectiveness of an intervention with a mobile adherence platform, compared to physician- or nurse-guided standard of care, to improve medication adherence to rivaroxaban in participants who have recently initiated treatment with rivaroxaban for stroke prevention in atrial fibrillation based on an assessment of the proportion of days covered (PDC) of rivaroxaban treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: March 22, 2018
• Est. primary completion date: March 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A history of atrial fibrillation

• Taking newly-prescribed rivaroxaban for atrial fibrillation for less than or equal to (<=) 90 days or who are about to initiate therapy (with a prescription dated in the last 90 days)

• At least 1 of the 4 questions answered "yes" from the four-item Morisky Medication Adherence Scale (MMAS-4)

• Possession of a compatible smartphone with an active phone number, text and data plan. The smartphone must be in continued possession of the participant. It may not be a shared device and must exclusively remain in the possession of the participant during the study period. The smartphone must have an active cellular phone number and cellular data subscription. WiFi internet capability is not a substitute for an active cellular data plan

• Willing to have the adherence application installed on a smartphone and use it every day during the entire study period

• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study and is willing to authorize the study team to contact the participant's pharmacy for oral anticoagulation medication and refill data

• Willing to provide oral confirmation indicating that he/she has not previously used a medication adherence application

• Ability to read and understand English

Exclusion Criteria:

• Anticipated inability to adhere to the mobile application (Care4Today) based on opinion of site Principal Investigator (PI)

• Anticipated rivaroxaban use less than (<) 12 months based on clinical documentation or participant interview

• Prescribed rivaroxaban for indications other than atrial fibrillation (Prescriptions for concomitant conditions are allowed as long as 1 of the indications is atrial fibrillation)

• Current use of: specialized anticoagulation clinics for rivaroxaban medication management; specialized pharmacist-led adherence or refill monitoring; or enrollment in a medication adherence program even if that program is for medications other than rivaroxaban

• Current use of adherence tracking devices, hardware, smartphone or computer applications, including but not limited to smart pill bottles, pill timers, radiofrequency tagged medications or dispensers, mobile applications, or automated phone reminders. Pharmacy and health care plan automated refill reminders are permitted and are not exclusion. Pill organizers or containers that only compartmentalize a participant's medications based on days of the week are not exclusion. Pill organizers that remind participants when to take medicine with beeps or alerts are exclusion

• Cognitive, visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone

• Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Mobile Application Intervention
Mobile phone application that sends reminders and allows participants to self-manage their medication adherence. Monitoring of participant adherence from this tool will be performed by the central coordinating center, which will send notifications or contact the participant based on the adherence history in accordance with the study protocol.

Other:
• No Intervention
Participants will receive physician- or nurse-guided standard of care.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Days Covered (PDC)	Adherence to rivaroxaban medication will be estimated based on validated PDC algorithm. PDC (expressed as percentage) defined as non-hospitalized days during which oral anticoagulant (OAC) will be supplied and consumed over total observation time duration during which rivaroxaban should have been consumed.	Month 6
Secondary	Percentage of Participants With PDC Greater Than or Equal to (>=) 80 Percent	PDC defined as non-hospitalized days during which oral anticoagulant (OAC) will be supplied and consumed over total observation time duration during which rivaroxaban should have been consumed.	Month 6
Secondary	Change From Baseline in the Average Score on the Eight-item Morisky Medication Adherence Scale (MMAS-8)	The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation.	Month 6
Secondary	Measure of Medication Persistence of Rivaroxaban	Measure of medication persistence of rivaroxaban defined as the percentage of participants on rivaroxaban with an active prescription at 6 months.	Month 6