Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management

NCT ID: NCT05400837

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2024-05-23

Brief Summary

The overall objective of this proposal is to evaluate the feasibility of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.

Researchers plan to evaluate the feasibility and preliminary efficacy of this novel digital toolkit in improving quality of life and decreasing AFib burden in a pilot randomized clinical trial (RCT).

Conditions

Atrial Fibrillation; Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Corrie Virtual Atrial Fibrillation Management Program

Multicomponent virtual atrial fibrillation management program

Group Type: EXPERIMENTAL

Corrie Virtual Atrial Fibrillation Management Program

Intervention Type: COMBINATION_PRODUCT

Intervention aims to implement guideline-recommended Afib care

Usual Care

Receives usual care. Usual care is defined as care according to the patients care team's standard practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Corrie Virtual Atrial Fibrillation Management Program

Intervention aims to implement guideline-recommended Afib care

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• Non- valvular Paroxysmal Atrial Fibrillation

Exclusion Criteria

• Non-English speaking
• Has previously been evaluated by a cardiologist or electrophysiologist
• Mitral Stenosis
• Presence of Artificial Heart Valve
• Severe valvular disease (any)
• Physical disability that would preclude technology use, safe and adequate exercise performance
• Hearing or Visual Impairment that would preclude technology use
• History of fall one or more times in the last year
• Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of >25 mmHg
• Known aortic dissection
• Severe resting arterial hypertension (SBP >200 mmHg or diastolic BP >110mmHg) upon enrollment (obtained during clinic visit)
• Mental impairment leading to inability to cooperate with study procedures
• Untreated high degree atrioventricular block
• Atrial fibrillation with rapid ventricular rate (Resting heart rate at enrollment visit >110) upon enrollment (obtained during clinic visit)
• History of cardiac arrest, sudden death
• MI or cardiac surgery complications of cardiogenic shock and/or congestive heart failure (CHF) and/or signs/symptoms of post-procedure ischemia
• Left ventricular ejection fraction <40%
• Clinically significant depression
• Presence of implanted cardiac device
• Incomplete revascularization procedure
• Pregnancy
• Previous open-heart surgery
• Unsafe to participate in the program as per treating clinician

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

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Spragg, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00321575

Identifier Type: -

Identifier Source: org_study_id