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Contemp Clin Trials. 2017 Nov;62:153-158. doi: 10.1016/j.cct.2017.09.005. Epub 2017 Sep 18.

Rationale and design of the Atrial Fibrillation health Literacy Information Technology Trial: (AF-LITT).

Author information

1
Department of Medicine, University of Pittsburgh Medical Center, 200 Lothrop Street, Pittsburgh, PA 15213, United States.
2
Division of Cardiology, Department of Medicine, UPMC Heart and Vascular Institute, University of Pittsburgh, 200 Lothrop Street, Pittsburgh, PA 15213, United States.
3
Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine, 801 Massachusetts Avenue, Boston, MA 02118, United States.
4
College of Computer and Information Science, Northeastern University, 360 Huntington Avenue, Boston, MA 02115, United States.
5
Division of Cardiology, Department of Medicine, UPMC Heart and Vascular Institute, University of Pittsburgh, 200 Lothrop Street, Pittsburgh, PA 15213, United States. Electronic address: magnanij@pitt.edu.

Abstract

BACKGROUND:

Atrial Fibrillation (AF) is a common cardiac arrhythmia that is challenging for patients and adversely impacts health-related quality of life (HRQoL). Long-term management of AF requires that patients adhere to complex therapies, understand difficult terminology, navigate subspecialty care, and have continued symptom monitoring with the goal of preventing adverse outcomes. Continued interventions to ameliorate the patient experience of AF are essential.

DESIGN:

The Atrial Fibrillation health Literacy Information Technology Trial (AF-LITT; NCT03093558) is an investigator-initiated, 2-arm randomized clinical trial (RCT). This RCT is a pilot in order to implement a novel, smartphone-based intervention to address the patient experience of AF. This pilot RCT will compare a combination of the Embodied Conversational Agent (ECA) and the Alive Cor Kardia Mobile heart rhythm monitor to the current standard of care. The study will enroll 180 adults with non-valvular AF who are receiving anticoagulation for stroke prevention and randomize them to receive a 30-day intervention (smartphone-based ECA/Kardia) or standard of care, which will include a symptom and adherence journal. The primary end-points are improvement in HRQoL and self-reported adherence to anticoagulation. The secondary end-points are the acceptability of the intervention to participants, its use by participants, and acceptability to referring physicians.

CONCLUSIONS:

The AF-LITT pilot aims to evaluate the efficacy of the ECA/Kardia to improve HRQoL and anticoagulant adherence, and to guide its implementation in a larger, multicenter clinical trial. The intervention has potential to improve HRQoL, adherence, and health care utilization in individuals with chronic AF.

KEYWORDS:

Adherence; Atrial fibrillation; Health-related quality of life; Randomized clinical trial; Relational agents

PMID:
28923492
PMCID:
PMC5641265
DOI:
10.1016/j.cct.2017.09.005
[Indexed for MEDLINE]
Free PMC Article

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