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OpenTrials
Completed

NCT Number: NCT03515083

Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm

There is a need to determine actual compliance of direct oral anticoagulants and how to improve this to reduce risk of stroke in patients with atrial fibrillation. Mobile health tools have been implemented world-wide in various patient populations as means of reducing cardiovascular risk and improving disease management. Results of these interventions have been mixed with some interventions demonstrating significant improvement while others demonstrated no difference between the intervention group and the control group. More importantly, these studies indicate that implementation of mobile health tools is feasible in various patient populations and it may just be a matter of finding the correct intervention for a given disease state. The aim of this study is to increase awareness of atrial fibrillation as a means of improving compliance with anticoagulant medication.

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Key information

Conditions

Non-valvular Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Luke's Health System

Kansas City, Missouri, 64111, United States

About this study

The primary hypothesis of this study is that patients with atrial fibrillation will have improved compliance with apixaban therapy if they complete a daily measurement of heart rhythm via a smartphone electrocardiogram monitor, as compared to patients managed in a conventional manner.

Primary Endpoint

  • Primary Endpoint 1: is the percent compliance with apixaban therapy as measured by the amount of apixaban medication that was consumed per month. Compliance is defined as "the extent to which a patient acts in accordance with the prescribed interval and dose of a dosing regimen." Percent compliance will be measured as a continuous variable and strict cutoffs for 'compliant' and 'non-compliant' status will not be imposed.

Secondary Endpoints

  • Secondary Endpoint 1: is the number of deaths from any cause, stroke, and hospitalization for atrial fibrillation and/or congestive heart failure. Given the low numbers of patients in this study, this will be a composite endpoint of all of these outcomes, since there is insufficient sample size to examine each outcome individually.
  • Secondary Endpoint 2: is the self assessment of atrial fibrillation symptom severity through the use of a standardized scale.

While the secondary endpoints are not directly related to the primary endpoint, there is a possibility that the intervention may lead to changes in health maintenance behavior, which may lead to differences in the secondary endpoints. While this study may not be powered to differentiate between these secondary endpoints, if a trend is noted, this may be hypothesis generating for future studies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-valvular atrial fibrillation that is either paroxysmal, persistent or permanent
  • CHA2DS2VASc score of 2 or more
  • Eligible for therapy with apixaban for at least 6 months
  • Possession of a smartphone capable of pairing with the AliveCor Kardia cardiac monitor

Exclusion criteria

  • Contraindication to anticoagulation with apixaban for at least 6 months
  • No access to a smartphone capable of pairing with the AliveCor Kardia cardiac monitor
  • Unable to provide informed consent for this protocol

Treatment and study plan

Alive Cor Kardia mobile electrocardiogram monitor

Device

Mobile ECG monitor paired with smart phone application

Primary outcomes

  1. anticoagulation compliance

    Time frame: 12 months

    percent compliance with apixaban therapy

Secondary outcomes

  1. composite of deaths, strokes, and hospitalizations

    Time frame: 12 months

    number of deaths from any cause, stroke, and hospitalization for atrial fibrillation and/or congestive heart failure

  2. AF symptom severity

    Time frame: 12 months

    self assessment of atrial fibrillation symptom severity through the use of a the Atrial Fibrillation Effect on QualiTy of Life (AFEQT) Questionnaire. Section 1 of the scale gathers details about whether or not the patient is symptomatic and how often they are having symptoms. Section 2 is evaluated as a score from 14-98 indicating the total effect of atrial fibrillation on quality of life. Lower values represent a better outcome. Subscales are not combined.

Sponsors and collaborators

Lead sponsor

Saint Luke's Health System

Other

Collaborators

  • AliveCor
  • Bristol-Myers Squibb

Registry information

Official study title

Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm (BOAT OAR)

Acronym: BOAT OAR

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 3, 2018
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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