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Atrial FibrillationPhase 4NCT02996435

Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation

A Phase 4 study testing Mobile Application Intervention in people with Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Mobile Application Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
25 sitesUnited States
Study dates
21 Dec 2016to 22 Mar 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Study site

    Anchorage, Alaska

  • Study site

    Austin, Texas

  • Study site

    Bellevue, Washington

  • Study site

    Buffalo, New York

  • Study site

    Canton, Ohio

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Jamaica, New York

  • Study site

    Lake Success, New York

  • Study site

    Lexington, Kentucky

  • Study site

    Los Angeles, California

  • Study site

    Manhattan Beach, California

  • Study site

    Memphis, Tennessee

  • Study site

    Mineola, New York

  • Study site

    Nashville, Tennessee

  • Study site

    Oakland, California

  • Study site

    Overland Park, Kansas

  • Study site

    Pasadena, California

  • Study site

    Pensacola, Florida

  • Study site

    Reading, Pennsylvania

  • Study site

    Reno, Nevada

  • Study site

    Saint Joseph, Michigan

  • Study site

    Saratoga Springs, New York

  • Study site

    Stanford, California

  • Study site

    Ventura, California

  • Study site

    Yardley, Pennsylvania

Other trials in United States

About this study

Official title: smartADHERE - Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation

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.

Being tested
Mobile Application Intervention, No Intervention
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile Application InterventionBehavioural

    Also called Care4Today®

    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.

  • No InterventionOther

    Participants will receive physician- or nurse-guided standard of care.

Study groups in NCT02996435
Study groupRoleWhat they receive
Mobile Adherence PlatformExperimentalParticipant adherence will be monitored using a mobile application and platform which provides a real-time reminder that alerts the participant to take his or her medication. The application will also send an alert to the participant when a refill is needed based on calculated medication or pill supply. The intervention will focus only on daily adherence to rivaroxaban.
Receives: Behavioral: Mobile Application Intervention
Control: Standard of CareOtherParticipants will receive physician- or nurse-guided standard of care for their rivaroxaban adherence. No drug will be administered as part of this study.
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 6

Secondary outcomes (3)

  1. 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.

    Measured: Month 6

  2. 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.

    Measured: Month 6

  3. 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.

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2016 (estimated)
  2. Study start21 Dec 2016
  3. Primary completion22 Mar 2018
  4. Study completion22 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02996435
Sponsor's protocol ID
CR108260
Other IDs
39039039AFL4010
Status last verified
Oct 2018
First submitted
15 Dec 2016
Last updated
26 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33676886

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mobile Application Intervention in people with Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Days Covered (PDC) (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02996435, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.

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