Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management

NCT05400837 | Completed Results FDA Device

• 1 other identifier: IRB00321575
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this proposal is to evaluate the feasibility 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 feasibility and preliminary efficacy of this novel digital toolkit in improving quality of life and decreasing AFib burden in a pilot randomized clinical trial (RCT).

Conditions

Atrial Fibrillation; Behavior

Keywords

Remote Patient Monitoring; Atrial Fibrillation; Risk Factor Modification; Digital Health; Mobile Health

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Continue Study Participation at 12 Weeks

  Feasibility assessed by retention at 12 weeks (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion)

  12 weeks

Secondary Outcomes (12)

• Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life

  12 weeks

• Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale

  12 weeks

• Skills in Applying Electronic Health Information to Health Problems

  12 weeks

• Depressive Symptoms as Assessed by the Patient Health Questionnaire 8

  12 weeks

• Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score

  12 weeks

Other Outcomes (1)

• At-home Sleep Study Results

  Studies were completed one time between enrollment and end of treatment at 12 weeks

Study Arms (2)

Corrie Virtual Atrial Fibrillation Management Program

EXPERIMENTAL

Multicomponent virtual atrial fibrillation management program

Combination Product: Corrie Virtual Atrial Fibrillation Management Program

Usual Care

NO INTERVENTION

Receives usual care. Usual care is defined as care according to the patients care team's standard practice

Interventions

Corrie Virtual Atrial Fibrillation Management Program COMBINATION_PRODUCT

Intervention aims to implement guideline-recommended Afib care

Corrie Virtual Atrial Fibrillation Management Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Non- valvular Paroxysmal Atrial Fibrillation

You may not qualify if:

• Non-English speaking
• Has previously been evaluated by a cardiologist or electrophysiologist
• Mitral Stenosis
• Presence of Artificial Heart Valve
• Severe valvular disease (any)
• Physical disability that would preclude technology use, safe and adequate exercise performance
• Hearing or Visual Impairment that would preclude technology use
• History of fall one or more times in the last year
• Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of \>25 mmHg
• Known aortic dissection
• Severe resting arterial hypertension (SBP \>200 mmHg or diastolic BP \>110mmHg) upon enrollment (obtained during clinic visit)
• Mental impairment leading to inability to cooperate with study procedures
• Untreated high degree atrioventricular block
• Atrial fibrillation with rapid ventricular rate (Resting heart rate at enrollment visit \>110) upon enrollment (obtained during clinic visit)
• History of cardiac arrest, sudden death

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Behavior

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nino Isakadze
• Organization: Johns Hopkins University

nisakad1@jh.edu

443-997-0270

Study Officials

• David Spragg, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 2, 2022
• Study Start: June 26, 2023
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)