Secondary Prevention of Atrial Fibrilation

NCT ID: NCT03259893

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-05-11

Brief 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.

Detailed Description

The proposed study is designed as a Hybrid Type 3 effectiveness-implementation study. This study design will enable the investigators to primarily focus on core implementation outcomes while also assessing the effectiveness of the intervention on clinical outcomes. Since this is a Type 3 Hybrid trial, there are both effectiveness and implementation evaluation components, but the primary focus is on the implementation outcomes of feasibility, acceptability, adoption, and appropriateness. The specific aims, data collection, and analytic plans are grounded in the Proctor Conceptual Model of Implementation Research that posits improvements in outcomes are dependent not only on the evidence-based interventions that are implemented but on the implementation strategies used to implement those interventions. The model distinguishes between the intervention strategy (evidence-based practice), different types of implementation strategies (system environment, organizational, group/learning, supervision, individual providers/consumers), and three levels of outcomes (implementation, service, and client). The appropriate outcome measures in each category (implementation, service, client) depend upon the specific evidence-based practice and local context.

AF patients with a BMI of ≥ 27 kg/m2, who are referred to outpatient cardiology clinic, inpatient cardiology service, or cardiology consult service at Boston Medical Center (BMC) will be screened until 50 participants are enrolled. Eligible participants will undergo 1:1 randomization to standard of care (SoC -group 1) or to the interdisciplinary AF program (intervention- group 2). Randomization will be performed using a computer randomizer algorithm with 5 blocks of 6 and 5 blocks of 4 in random order for a total of 50 participants. The rational for the randomization design is primarily for the purpose of feasibility and to establish effect sizes and guide the design of the future trial.

All patients will be enrolled for a total duration of six months. Outcomes will be measured via 30-minute individual interviews at the end of 6-months. The implementation and service outcomes will be examined including acceptability, appropriateness, adoption, feasibility, and patient centeredness, as well as the client outcomes of satisfaction, function and symptomatology. Data will be collected using both quantitative and qualitative data methods to determine which aspects of the program achieved good patient adherence and acceptability.

Conditions

Atrial Fibrillation; Risk Factors; Risk Reduction Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of care group 1

Participants randomized to the standard of care group will receive guideline-directed medical therapy according to clinical standard practice at Boston Medical Center. Each participant will receive an AliveCor mobile ECG cardiac monitor which is capable of providing real-time heart telemetry using a smart phone.

Group Type: ACTIVE_COMPARATOR

AliveCor mobile ECG cardiac monitor

Intervention Type: OTHER

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.

Standard of care

Intervention Type: OTHER

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

Intervention group 2

The intervention group will receive the AF program which include a bundle of sub-interventions that target specific AF risk factors including hypertension, obesity, physical inactivity, sleep hygiene, and smoking. Each participant will receive an AliveCor mobile ECG cardiac monitor which is capable of providing real-time heart telemetry using a smart phone.

Group Type: EXPERIMENTAL

AliveCor mobile ECG cardiac monitor

Intervention Type: OTHER

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.

AF Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Standard of care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older
• Diagnosis of paroxysmal AF (based on 12-lead electrocardiogram or event monitor showing AF).
• Body mass index of greater than 27 kg/m2
• Eligibility to participate in cardiac rehabilitation with negative exercise stress test within 6 months.

Exclusion Criteria

• Permanent AF.
• Undergone catheter ablation of AF in past 6 months.
• Class I or Class III anti-arrhythmic drugs at the time of enrollment
• Unable to participate in cardiac rehabilitation.
• Prognosis of less than 1-year.
• Do not own a smart phone.
• Unable to operate (transmit data) their smart phone.
• Are not fluent in English or Spanish.
• Unable to read in English or Spanish.
• Not able to provide informed consent.
• Women who are pregnant.
• Prisoners.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Helm, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-36040

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-36040

Identifier Type: -

Identifier Source: org_study_id