RECRUITING

Mobile Health Technology-Enabled AFib Management

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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

Quick Facts

Study Start:2025-06-03
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06500988

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged 18 or older at time of consent
  2. 2. Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation
  3. 3. BMI (Body Mass Index) ≥ 27.0
  1. 1. Permanent Afib (decision has been made not to attempt sinus rhythm)
  2. 2. Severe valvular disease
  3. 3. Moderate mitral valve stenosis
  4. 4. Prior cardiac surgery
  5. 5. Presence of implanted cardiac device
  6. 6. History of cardiac arrest
  7. 7. Left ventricular ejection fraction (LVEF) ≤ 35%
  8. 8. Life expectancy \< 1 year
  9. 9. Non-English speaking
  10. 10. Treating clinician deems unsafe for exercise
  11. 11. Any other reason that makes patient unsuitable for study at the discretion of the PI

Contacts and Locations

Study Contact

Nino Isakadze
CONTACT
410-955-5999
nisakad1@jhmi.edu

Principal Investigator

David Spragg, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • David Spragg, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-03
Study Completion Date2028-06

Study Record Updates

Study Start Date2025-06-03
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Behavior