Clinical trial NCT02996435: Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation
Official title: smartADHERE - Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2016-12-19
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Days Covered (PDC)
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants With PDC Greater Than or Equal to (>=) 80 Percent
timeFrame: Month 6
measure: Change From Baseline in the Average Score on the Eight-item Morisky Medication Adherence Scale (MMAS-8)
timeFrame: Month 6
measure: Measure of Medication Persistence of Rivaroxaban
timeFrame: Month 6
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Los Angeles
country: United States
state: California
city: Manhattan Beach
country: United States
state: California
city: Oakland
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Stanford
country: United States
state: California
city: Ventura
country: United States
state: California
city: Pensacola
country: United States
state: Florida
city: Overland Park
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Saint Joseph
country: United States
state: Michigan
city: Reno
country: United States
state: Nevada
city: Buffalo
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: Saratoga Springs
country: United States
state: New York
city: Canton
country: United States
state: Ohio
city: Doylestown
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: Yardley
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Bellevue
country: United States
state: Washington
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Turakhia M, Sundaram V, Smith SN, Ding V, Michael Ho P, Kowey PR, Piccini JP, Foody J, Birmingham MC, Ianus J, Rajmane A, Mahaffey KW; smartADHERE Investigators. Efficacy of a centralized, blended electronic, and human intervention to improve direct oral anticoagulant adherence: Smartphones to improve rivaroxaban ADHEREnce in atrial fibrillation (SmartADHERE) a randomized clinical trial. Am Heart J. 2021 Jul;237:68-78. doi: 10.1016/j.ahj.2021.02.023. Epub 2021 Mar 4.