RECRUITING

Mobile Health Technology-Enabled AFib Management

Description

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 Overview

Study Details

Study overview

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)

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

Mobile Health Technology-Enabled AFib Management

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States, 21224

Baltimore

Johns Hopkins Outpatient Center, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

David Spragg, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2028-06