Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm

Non-valvular Atrial Fibrillation Clinical Trial

— BOAT OAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515083
• Other study ID #: CV185-584
• Status: Completed
• Phase: N/A
• Start date: July 17, 2017
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2023
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Intervention

Device:
• Alive Cor Kardia mobile electrocardiogram monitor
Mobile ECG monitor paired with smart phone application

Locations

Country	Name	City	State
United States	Saint Luke's Health System	Kansas City	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Saint Luke's Health System	AliveCor, Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (8)

Cramer JA, Roy A, Burrell A, Fairchild CJ, Fuldeore MJ, Ollendorf DA, Wong PK. Medication compliance and persistence: terminology and definitions. Value Health. 2008 Jan-Feb;11(1):44-7. doi: 10.1111/j.1524-4733.2007.00213.x. — View Citation

Cutler TW, Chuang A, Huynh TD, Witt RG, Branch J, Pon T, White R. A retrospective descriptive analysis of patient adherence to dabigatran at a large academic medical center. J Manag Care Spec Pharm. 2014 Oct;20(10):1028-34. doi: 10.18553/jmcp.2014.20.10.1028. — View Citation

McHorney CA, Crivera C, Laliberte F, Nelson WW, Germain G, Bookhart B, Martin S, Schein J, Lefebvre P, Deitelzweig S. Adherence to non-vitamin-K-antagonist oral anticoagulant medications based on the Pharmacy Quality Alliance measure. Curr Med Res Opin. 2015 Dec;31(12):2167-73. doi: 10.1185/03007995.2015.1096242. Epub 2015 Oct 22. — View Citation

Piette JD, List J, Rana GK, Townsend W, Striplin D, Heisler M. Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management. Circulation. 2015 Nov 24;132(21):2012-27. doi: 10.1161/CIRCULATIONAHA.114.008723. — View Citation

Schulman S, Shortt B, Robinson M, Eikelboom JW. Adherence to anticoagulant treatment with dabigatran in a real-world setting. J Thromb Haemost. 2013 Jul;11(7):1295-9. doi: 10.1111/jth.12241. — View Citation

Shore S, Carey EP, Turakhia MP, Jackevicius CA, Cunningham F, Pilote L, Bradley SM, Maddox TM, Grunwald GK, Baron AE, Rumsfeld JS, Varosy PD, Schneider PM, Marzec LN, Ho PM. Adherence to dabigatran therapy and longitudinal patient outcomes: insights from the veterans health administration. Am Heart J. 2014 Jun;167(6):810-7. doi: 10.1016/j.ahj.2014.03.023. Epub 2014 Apr 5. — View Citation

Spertus J, Dorian P, Bubien R, Lewis S, Godejohn D, Reynolds MR, Lakkireddy DR, Wimmer AP, Bhandari A, Burk C. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):15-25. doi: 10.1161/CIRCEP.110.958033. Epub 2010 Dec 15. — View Citation

Zhou M, Chang HY, Segal JB, Alexander GC, Singh S. Adherence to a Novel Oral Anticoagulant Among Patients with Atrial Fibrillation. J Manag Care Spec Pharm. 2015 Nov;21(11):1054-62. doi: 10.18553/jmcp.2015.21.11.1054. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anticoagulation compliance	percent compliance with apixaban therapy	12 months
Secondary	composite of deaths, strokes, and hospitalizations	number of deaths from any cause, stroke, and hospitalization for atrial fibrillation and/or congestive heart failure	12 months
Secondary	AF symptom severity	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.	12 months