Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm
NCT ID: NCT03515083
Last Updated: 2023-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2017-07-17
2022-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Alive Cor Kardia mobile electrocardiogram monitor
Mobile ECG monitor paired with smart phone application
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.
No interventions assigned to this group
Interventions
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Alive Cor Kardia mobile electrocardiogram monitor
Mobile ECG monitor paired with smart phone application
Eligibility Criteria
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Inclusion Criteria
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
2. No access to a smartphone capable of pairing with the AliveCor Kardia cardiac monitor
3. Unable to provide informed consent for this protocol
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AliveCor
INDUSTRY
Saint Luke's Health System
OTHER
Responsible Party
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Principal Investigators
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Sanjaya Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Luke's Health System
Locations
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Saint Luke's Health System
Kansas City, Missouri, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Tran AT, Okasha OM, Steinhaus DA, Yousuf OK, Giocondo MJ, Ramza BM, Wimmer AP, Gupta SK. Prospective evaluation of the effect of smartphone electrocardiogram usage on anticoagulant medication compliance. J Interv Card Electrophysiol. 2022 Nov;65(2):453-460. doi: 10.1007/s10840-022-01235-8. Epub 2022 May 5.
Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.
Other Identifiers
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CV185-584
Identifier Type: -
Identifier Source: org_study_id
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