Mobile Health Technology-Enabled AFib Management

Purpose

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)

Conditions

  • Atrial Fibrillation
  • Behavior

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Corrie Virtual Atrial Fibrillation Management Program 		Multicomponent virtual atrial fibrillation management program
  • Combination Product: Corrie Virtual Atrial Fibrillation Management Program
    Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit
No Intervention
Usual Care 		Receives usual care. Usual care is defined as care according to the patients care team's standard practice

Recruiting Locations

Johns Hopkins Bayview Medical Center
Baltimore, Maryland 21224
Contact:
Natalie Horstman
443-839-0803
nhorstm3@jh.edu

Johns Hopkins Outpatient Center
Baltimore, Maryland 21287
Contact:
Natalie Horstman
443-839-0803
nhorstm3@jh.edu

More Details

Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

Nino Isakadze
410-955-5999
nisakad1@jhmi.edu