Secondary Prevention of Atrial Fibrilation

Boston Medical Center Secondary Prevention of Atrial Fibrillation Randomized Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation; Risk Factors; Risk Reduction Behavior
• Intervention / Treatment: Other: AliveCor mobile ECG cardiac monitor; Other: Standard of care; Behavioral: AF Program

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other: Standard of care; Guideline-directed medical therapy according to clinical standard practice at Boston Medical Center.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the AF program	Quantitative measure of willingness to enroll and attend nutrition clinic, cardiac rehabilitation clinic, and frequency of use of Alivecor device, smart Scale, Fitbit device will be aggregated to generate a single feasibility score to determine overall feasibility of the AF program. The feasibility score will be generated by the following formula: = 100 * average of { (actual nutrition clinic attendance/ expected nutrition clinic attendance) + (actual cardiac rehab clinic attendance/ expected cardiac rehab clinic attendance) + (actual use of smart phone enabled devices/expected use of smart phone enabled devices)} A feasibility score closer to 100% indicates good feasibility.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the AF program	Data from qualitative interviews will be coded using a process analytic framework and inductive logic to create a set of conceptual categories using the Constant Comparative Method and used to assess patient-centeredness and satisfaction which will reflect acceptability of the AF program.	6 months
Most acceptable individual component of the AF program	Data from qualitative interviews will be coded using a process analytic framework and inductive logic to create a set of conceptual categories using the Constant Comparative Method and used to compare the acceptability of individual component of AF programs including nutrition clinic, cardiac rehabilitation clinic, smoking cessation clinic, smart phone enable health devices.	6 months
Most adopted individual component of the AF program	Quantitative measure of (actual clinic attendance or use of smart phone enable devices) / (expected clinic attendance or use of smart phone enable devices) will be compared for the various components of the AF program including nutrition clinic, cardiac rehabilitation clinic, smoking cessation clinic, Alivecor device, Fitbit device, smart blood pressure monitor, and smart scale. The individual component with the highest % attendance or use will be considered to be the most adopted individual component of the AF program.	6 months
Burden of atrial fibrillation	Quantitative measure of telemetry data from Alivecor devices, participants will be instructed to transmit telemetry data twice weekly and during symptomatic AF episodes. Telemetry data showing AF will be used to determine number of AF episodes in each participant over time.	Twice weekly for 6 months
Atrial fibrillation symptoms	quantitative measure of telemetry data from Alivecor devices and qualitative measures using The Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire is a 20 question, 7 point Likert scale (1-7) instrument that takes about 5 minutes to complete and evaluates Health Related Quality of Life across 3 domains- symptoms (4 questions), daily activities (8 questions), and treatment concerns (6 questions). The range of scores are 20-140, lower scores are favorable.	6 months
Atrial fibrillation literacy	AF Knowledge Questionnaire is a 34 question instrument that takes about 10 minutes to complete. It is a modified version of the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ) and contains questions about AF in general and about oral anticoagulation therapy.	6 months
Atrial Fibrillation Effect on Quality of Life	The Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire is a 20 question, 7 point Likert scale (1-7) instrument that takes about 5 minutes to complete and evaluates Health Related Quality of Life across 3 domains- symptoms (4 questions), daily activities (8 questions), and treatment concerns (6 questions). The range of scores are 20-140, lower scores are favorable.	6 months
Hospitalization for atrial fibrillation	quantitative measure of number of hospitalization for atrial fibrillation or outcome attributed to atrial fibrillation	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Quantitative measure of total weight loss over the duration of the study	6 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: BU Clinical Translational Science Institute
• Investigators: Principal Investigator: Robert Helm, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): May 11, 2020
• Study Completion (Actual): May 11, 2020

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Prevention; Proctor Conceptual Model of Implementation Research; Safety net hospital; Diverse inner city patients
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: H-36040 (Other Grant/Funding Number: Boston Medical Center through CTSI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes