Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm

Not Applicable

Completed

• Conditions: Non-valvular Atrial Fibrillation
• Interventions: Device: Alive Cor Kardia mobile electrocardiogram monitor

• Registration Number: NCT03515083
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-07-17
• Study First Submitted: 2018-04-21
• Study First Submitted QC: 2018-04-21
• Study First Posted: 2018-05-03
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Alive Cor Kardia mobile electrocardiogram monitor	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.

Primary Outcome Measures

Name	Time	Method
anticoagulation compliance	12 months	percent compliance with apixaban therapy

Secondary Outcome Measures

Name	Time	Method
AF symptom severity	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.
composite of deaths, strokes, and hospitalizations	12 months	number of deaths from any cause, stroke, and hospitalization for atrial fibrillation and/or congestive heart failure

Trial Locations

Locations (1)

Saint Luke's Health System; 🇺🇸 Kansas City, Missouri, United States