Secondary Prevention of Atrial Fibrilation

Summary

Atrial fibrillation (AF) is the most common arrhythmia affecting over 3 million Americans and about 33.5 million individuals globally. The lifetime risk of developing AF is 1 in 4 for adults over age 40 years. AF is associated with a major medical and socioeconomic burden including high cost, increased risk of stroke, heart failure, dementia, myocardial infarction, and death. Numerous studies have demonstrated that modifiable risk factors including hypertension, obesity, sleep apnea, diabetes, and sedentary lifestyle predict the development of AF.

Recent studies have reported that secondary prevention interventions through aggressive risk factor modification can reduce the burden of AF. Structured, physician and nursing-led interdisciplinary AF programs have been shown to improve patient adherence to guideline recommendations and improve long term prognosis. Previous data, however, are derived mainly from white European and Australian cohorts and it is unclear whether such interventions can be effectively implemented in a racially diverse, safety net hospital in the U.S.

This study is a randomized hybrid implementation-effectiveness study designed to investigate feasibility and effectiveness of an evidence-based innovative AF program, focusing on risk factor modification and AF education in a racially mixed population receiving care in a safety net hospital.

Conditions

• Atrial Fibrillation
• Risk Factors
• Risk Reduction Behavior

Interventions

OTHER

AliveCor mobile ECG cardiac monitor

AliveCor mobile ECG cardiac monitor is capable of providing real-time heart telemetry using a smart phone. Participants will be instructed to transmit rhythm data twice weekly and during symptomatic AF.

BEHAVIORAL

AF Program

The AF program includes a bundle of sub-interventions that target specific AF risk factors including hypertension, obesity, physical inactivity, sleep hygiene, and smoking. Participants randomized to the intervention group 2 will undergo counseling by the nurse and guided through the structured, goal-directed AF program. Each participant will receive an AliveCor cardiac monitor which is capable of providing real-time heart telemetry using a smart phone.

OTHER

Standard of care

Guideline-directed medical therapy according to clinical standard practice at Boston Medical Center.

Sponsors & Collaborators

• Boston University

  collaborator OTHER

• Boston Medical Center

  lead OTHER

Principal Investigators

• Robert Helm, MD · Boston Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-01

Primary Completion

2020-05-11

Completion

2020-05-11

Countries

• United States

Study Locations