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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
248
Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
RECRUITINGJohns Hopkins Outpatient Center
Baltimore, Maryland, United States
RECRUITINGParticipants Freedom from documented atrial tachyarrhythmia
Freedom from documented atrial tachyarrhythmia (atrial fibrillation/atrial flutter/atrial tachycardia) episodes of ≥30 seconds between 91 and 365 days after catheter ablation, on or off antiarrhythmic drugs.
Time frame: 91 to 365 days
Quality of Life as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT)
Quality of Life, measured by validated Atrial Fibrillation Effect on Quality of Life (AFEQT) score. Score ranges from 0 to 100 with higher scores signifying better quality of life
Time frame: 365 days
AFib burden (percentage of time)
Atrial fibrillation burden (expressed as a percentage of time in atrial fibrillation) between 91 days and 365 days after catheter ablation
Time frame: 91 to 365 days
Participants Freedom from atrial tachyarrhythmia off medication
Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between 91 days and 365 days after catheter ablation off medications.
Time frame: 91 to 365 days
Participants Freedom from atrial tachyarrhythmia on or off medications
Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between day 1 and day 365 after catheter ablation, on and off medications.
Time frame: 1 day to 365 days
Incidence of hospitalizations, emergency room visits, deaths
Safety (composite of hospitalizations, emergency room visits, deaths)
Time frame: 1 to 365 days
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