Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/16/2018 |
| Start Date: | July 17, 2017 |
| End Date: | July 31, 2020 |
Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm (BOAT OAR)
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.
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.
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.
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.
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
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