Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged 18 or older at time of consent

• Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation

• BMI (Body Mass Index) ≥ 27.0

Locations
United States
Maryland
Johns Hopkins Bayview Medical Center
RECRUITING
Baltimore
Johns Hopkins Outpatient Center
RECRUITING
Baltimore
Contact Information
Primary
Nino Isakadze
nisakad1@jhmi.edu
410-955-5999
Time Frame
Start Date: 2025-06-03
Estimated Completion Date: 2028-06
Participants
Target number of participants: 248
Treatments
Experimental: Corrie Virtual Atrial Fibrillation Management Program
Multicomponent virtual atrial fibrillation management program
No_intervention: Usual Care
Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University
Collaborators: Pharmaceutical Research & Manufacturers Of America Foundation, Itamar-Medical, Israel, Apple Inc.

This content was sourced from clinicaltrials.gov