Virtual Education Program for Atrial Fibrillation

Not currently recruiting at 2 trial locations
TA
Overseen ByTiffany Armbruster, AGNP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a virtual education program, called AF at Home, can help people with atrial fibrillation (irregular heartbeat) better manage their condition and improve their quality of life. Participants will join online sessions to learn self-monitoring and self-care strategies. The trial seeks adults diagnosed with atrial fibrillation. Participants will complete six hours of virtual sessions over three weeks and fill out questionnaires before and after the program.

As an unphased trial, this study offers participants a unique opportunity to gain valuable self-care skills and potentially enhance their quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on education rather than medication changes.

What prior data suggests that this virtual education program is safe for participants?

Research has shown that virtual education programs for atrial fibrillation (AF) are generally safe and easy to manage. A previous study, INFORM-AF, demonstrated positive results in improving quality of life for people with AF, without major side effects. Another study, AF-EduCare, found that both in-person and online education effectively increased knowledge about AF, again with no major safety concerns.

Although these studies did not identify any safety issues, it's important to note that the AF at Home program involves only online education sessions and questionnaires. These activities are non-invasive and low-risk, making serious side effects unlikely.12345

Why are researchers excited about this trial?

Researchers are excited about the "AF at Home" virtual education program for atrial fibrillation because it offers a unique approach to managing this common heart condition. Unlike traditional treatments that focus on medication or surgical interventions, this program empowers patients by providing them with easy access to educational resources and personalized support from the comfort of their homes. By enhancing patient knowledge and engagement, "AF at Home" has the potential to improve self-management and adherence to treatment plans, which could lead to better health outcomes. This innovative approach stands out because it taps into the power of technology to bridge the gap between patients and healthcare providers, potentially revolutionizing how atrial fibrillation is managed.

What evidence suggests that this virtual education program is effective for atrial fibrillation?

Research has shown that the AF at Home virtual education program, provided to all trial participants, can boost confidence in managing atrial fibrillation. In past studies, participants adhered better to their treatment plans. Programs like AF at Home also enhance understanding of atrial fibrillation, leading to improved self-care and management. Overall, these programs empower participants to feel more in control of their health, which is crucial for enhancing their quality of life.23467

Who Is on the Research Team?

AG

Anil Gehi, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for adults with atrial fibrillation, either non-valvular or valvular. Participants must be 18 years or older and capable of giving informed consent. It's not open to individuals who are incarcerated.

Inclusion Criteria

I have been diagnosed with atrial fibrillation not caused by heart valve issues.

Exclusion Criteria

Incarcerated patient
I am unable to understand and agree to the study's details on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Virtual Education Program

Participants engage in a virtual education program ('AF at Home') for atrial fibrillation, consisting of six hours of sessions over three weeks via Zoom.

3 weeks
Virtual sessions

Follow-up

Participants are monitored for improvement in quality of life, self-monitoring, and self-management strategies, as well as healthcare utilization and medication adherence.

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • AF at Home
Trial Overview The 'AF at Home' program is being tested to see if it improves quality of life and self-care in people with atrial fibrillation. Participants will attend six hours of virtual education over three weeks and complete questionnaires before and after the program.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: AF at HomeExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

Bristol-Myers Squibb Foundation

Collaborator

Trials
6
Recruited
1,300+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Wake Forest University

Collaborator

Trials
193
Recruited
151,000+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

Citations

Effect of a virtual self‐management intervention for atrial ...The results of this study show that the AF‐At‐Home program was effective at increasing self‐confidence in disease management and adherence to guideline‐ ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38096021/
Outcomes of a Remote Cardiac Rehabilitation Program for ...This study aims to assess the feasibility and effectiveness of a 12-week asynchronous remotely supervised exercise and patient education program.
Effectiveness of the AF-EduCare and AF-EduApp approach to ...The results show that targeted education improves patients' AF knowledge. However, targeted education did not affect patients' perception on ...
A pilot study of a digital education program (INFORM-AF) for ...This study aims to determine the system usability, feasibility, and efficacy of a digital education program (INFORM-AF) for patients living with ...
results of the multicentre randomized AF-EduCare trial | EP ...Education (both in-person and online) significantly improved AF-related knowledge compared to SC (P < 0.001), increased patient awareness about ...
Digitally enabled acute care for atrial fibrillationVirtual wards could be the way forward to manage acute AF patients through remote monitoring, especially with the rise in global access to digital ...
Digital monitoring and electronic patient-reported ...Lyons, et al. Systematic collection of patient-reported outcomes in atrial fibrillation: feasibility and initial results of the Utah mEVAL AF programme.
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