Mobile Health Technology-Enabled AFib Management (mTECH Afib)

Johns Hopkins University

Status: Enrolling

Conditions: Behavior; Atrial Fibrillation

Treatments: Combination Product: Corrie Virtual Atrial Fibrillation Management Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06500988

IRB00453569

Details and patient eligibility

About

The overall objective of this proposal is to evaluate the effect on quality of life 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 effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 or older at time of consent
2. Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation
3. BMI (Body Mass Index) ≥ 27.0

Exclusion criteria

1. Permanent Afib (decision has been made not to attempt sinus rhythm)
2. Severe valvular disease
3. Moderate mitral valve stenosis
4. Prior cardiac surgery
5. Presence of implanted cardiac device
6. History of cardiac arrest
7. Left ventricular ejection fraction (LVEF) ≤ 35%
8. Life expectancy < 1 year
9. Non-English speaking
10. Treating clinician deems unsafe for exercise
11. Any other reason that makes patient unsuitable for study at the discretion of the PI

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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248 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