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

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ClinicalTrials.gov Identifier: NCT03515083
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : September 24, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
AliveCor
Information provided by (Responsible Party):
Sanjaya Gupta, Saint Luke's Health System

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.

Condition or disease Intervention/treatment Phase
Non-valvular Atrial Fibrillation Device: Alive Cor Kardia mobile electrocardiogram monitor Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental

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.




Primary Outcome Measures :
  1. anticoagulation compliance [ Time Frame: 12 months ]
    percent compliance with apixaban therapy


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Missouri
Saint Luke's Health System Recruiting
Kansas City, Missouri, United States, 64111
Contact: Tina Baker, RN, BSN    816-932-0364    tkean@saint-lukes.org   
Contact: Cheryl Rutherford, RN, BSN    816-932-6275    cjrutherford@saint-lukes.org   
Sponsors and Collaborators
Sanjaya Gupta
Bristol-Myers Squibb
AliveCor
Investigators
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Principal Investigator: Sanjaya Gupta, MD Saint Luke's Health System

Publications:

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Responsible Party: Sanjaya Gupta, Assistant Professor of Medicine, University of Missouri-Kansas City, Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT03515083     History of Changes
Other Study ID Numbers: CV185-584
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Sanjaya Gupta, Saint Luke's Health System:
apixaban
atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants