Mobile Health Technology-Enabled AFib Management

NCT ID: NCT06500988

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2028-06-30

Brief Summary

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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)

Detailed Description

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Conditions

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Atrial Fibrillation Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Corrie Virtual Atrial Fibrillation Management Program

Multicomponent virtual atrial fibrillation management program

Group Type EXPERIMENTAL

Corrie Virtual Atrial Fibrillation Management Program

Intervention Type COMBINATION_PRODUCT

Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Corrie Virtual Atrial Fibrillation Management Program

Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmaceutical Research & Manufacturers Of America Foundation

UNKNOWN

Sponsor Role collaborator

Apple Inc.

INDUSTRY

Sponsor Role collaborator

Itamar-Medical, Israel

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Spragg, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nino Isakadze

Role: CONTACT

410-955-5999

Facility Contacts

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Natalie Horstman

Role: primary

443-839-0803

Natalie Horstman

Role: primary

443-839-0803

Other Identifiers

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IRB00453569

Identifier Type: -

Identifier Source: org_study_id

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