Clinical trial NCT03515083: Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm
Official title: Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm (BOAT OAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-valvular Atrial Fibrillation
Keywords: apixaban
atrial fibrillation
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: AliveCor
First posted: 2018-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, prospective
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

1. 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
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: anticoagulation compliance
timeFrame: 12 months
Secondary outcomes:
measure: composite of deaths, strokes, and hospitalizations
timeFrame: 12 months
measure: AF symptom severity
timeFrame: 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Health System
state: Missouri
Study officials:
affiliation: Saint Luke's Health System
name: Sanjaya Gupta, MD
role: PRINCIPAL_INVESTIGATOR
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