Mobile Health Technology-Enabled AFib Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Permanent Afib (decision has been made not to attempt sinus rhythm)
Severe valvular disease
Moderate mitral valve stenosis
Prior cardiac surgery
Trial design
Treatments tested in this trial
- Corrie Virtual Atrial Fibrillation Management Program
Treatment groups
248 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
Pharmaceutical Research & Manufacturers Of America Foundation
Collaborator
Apple Inc.
Collaborator
Itamar-Medical, Israel
Collaborator
Source ClinicalTrials.gov