Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm (BOAT OAR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03515083|
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-valvular Atrial Fibrillation||Device: Alive Cor Kardia mobile electrocardiogram monitor||Not Applicable|
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: 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, prospective|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm (BOAT OAR)|
|Actual Study Start Date :||July 17, 2017|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
In the experimental group, each patient will be issued an AliveCor Kardia electrocardiogram monitor that is compatible with their smartphone. Patients will be instructed on the use of the monitor at the initial visit with the study nurse. The patient will submit daily electrocardiogram transmission via on online portal. The study nurse may contact them via text message to remind them to submit their recordings, if they forget.
The remainder of the treatment of the experimental group will be identical to the control group. At the conclusion of the study, the patient will complete their final atrial fibrillation symptom assessment scale. Their smartphone electrocardiogram monitor will be reviewed to ensure that all of the recordings were retrieved successfully.
Device: Alive Cor Kardia mobile electrocardiogram monitor
Mobile ECG monitor paired with smart phone application
No Intervention: Control
Patients in the control group would receive the standard of care treatment for atrial fibrillation, including cardioversion and ablation as indicated. At monthly visits with the study nurse, a smartphone electrocardiogram monitor will be used to record patient's heart rhythm. No other intervention would be performed during the monthly visit. It is necessary to meet the subject at least once per month to receive the previous month's supply of pills and provide them with the next month's supply of pills. If these subjects were met less frequently, it is possible that the previous month's supply of pills might be lost by the end of the study.
During the study, if the patient is taken off anticoagulation due to medical contraindication or after an ablation, they will continue to be followed monthly but will not receive apixaban medication.
- anticoagulation compliance [ Time Frame: 12 months ]percent compliance with apixaban therapy
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515083
|Principal Investigator:||Sanjaya Gupta, MD||Saint Luke's Health System|