Mobile Health Technology-Enabled AFib Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Corrie Virtual Atrial Fibrillation Management Program.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Behavior. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2
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)
Interventions
- Combination product Corrie Virtual Atrial Fibrillation Management Program
Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit
Primary outcome measures
- Participants Freedom from documented atrial tachyarrhythmia [Time frame: 91 to 365 days]
Secondary outcome measures (5)
- Quality of Life as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT) [Time frame: 365 days]
- AFib burden (percentage of time) [Time frame: 91 to 365 days]
- Participants Freedom from atrial tachyarrhythmia off medication [Time frame: 91 to 365 days]
- Participants Freedom from atrial tachyarrhythmia on or off medications [Time frame: 1 day to 365 days]
- Incidence of hospitalizations, emergency room visits, deaths [Time frame: 1 to 365 days]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Permanent Afib (decision has been made not to attempt sinus rhythm)
- Severe valvular disease
- Moderate mitral valve stenosis
- Prior cardiac surgery
- Presence of implanted cardiac device
- History of cardiac arrest
- Left ventricular ejection fraction (LVEF) ≤ 35%
- Life expectancy < 1 year
- Non-English speaking
- Treating clinician deems unsafe for exercise
- Any other reason that makes patient unsuitable for study at the discretion of the PI
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Johns Hopkins Bayview Medical Center — Baltimore
- Johns Hopkins Outpatient Center — Baltimore
Identifiers
NCT: NCT06500988 · IRB00453569