Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management (mTECHAFib)

Johns Hopkins University

Status: Completed

Conditions: Behavior; Atrial Fibrillation

Treatments: Combination Product: Corrie Virtual Atrial Fibrillation Management Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05400837

IRB00321575

Details and patient eligibility

About

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).

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Corrie Virtual Atrial Fibrillation Management Program

Experimental group

Description:

Multicomponent virtual atrial fibrillation management program

Treatment:

Combination Product: Corrie Virtual Atrial Fibrillation Management Program

Usual Care

No Intervention group

Description:

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