Clinical trial NCT03259893: Secondary Prevention of Atrial Fibrilation
Official title: Boston Medical Center Secondary Prevention of Atrial Fibrillation Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Risk Factors
Risk Reduction Behavior
Keywords: Proctor Conceptual Model of Implementation Research
Prevention
Safety net hospital
Diverse inner city patients
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2017-08-24
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Feasibility of the AF program
timeFrame: 6 months
Secondary outcomes:
measure: Acceptability of the AF program
timeFrame: 6 months
measure: Most acceptable individual component of the AF program
timeFrame: 6 months
measure: Most adopted individual component of the AF program
timeFrame: 6 months
measure: Burden of atrial fibrillation
timeFrame: Twice weekly for 6 months
measure: Atrial fibrillation symptoms
timeFrame: 6 months
measure: Atrial fibrillation literacy
timeFrame: 6 months
measure: Atrial Fibrillation Effect on Quality of Life
timeFrame: 6 months
measure: Hospitalization for atrial fibrillation
timeFrame: 6 months
Other outcomes:
measure: Weight loss
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Robert Helm, MD
role: PRINCIPAL_INVESTIGATOR
References: