N/A
Completed N=61
Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management
Atrial Fibrillation · Behavior
Source: ClinicalTrials.gov NCT05400837 ↗
Enrolled (actual)
61
Serious AEs
1.6%
Results posted
Jul 2025
Primary outcomePrimary: Number of Participants Who Continue Study Participation at 12 Weeks — 26; 29 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Continue Study Participation at 12 Weeks |
26; 29 | — |
| SECONDARY Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life |
87.0; 76.0 | — |
| SECONDARY Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale |
11.3; 12.7; 3.1; 4.3; 4.6; 5.4 | — |
| SECONDARY Skills in Applying Electronic Health Information to Health Problems |
40.0; 40.1 | — |
| SECONDARY Depressive Symptoms as Assessed by the Patient Health Questionnaire 8 |
1.0; 3.0 | — |
| SECONDARY Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score |
1.0; 1.0 | — |
| SECONDARY Stress Level as Assessed by the Perceived Stress Score |
10.1; 11.5 | — |
| SECONDARY Physical Activity as Assessed by the Rapid Assessment of Physical Activity |
5.0; 5.0; 1.0; 2.0 | — |
| SECONDARY Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test |
2.0; 2.0 | — |
| SECONDARY Diet as Assessed by the Rate Your Plate (RYP) Scale |
65.1; 64.0 | — |
| SECONDARY Blood Pressure |
123.1; 123.3; 75.6; 73.4 | — |
| SECONDARY Body Mass Index (BMI) |
29.6; 29.9 | — |
| SECONDARY Satisfaction With Intervention |
78.25 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- Non- valvular Paroxysmal Atrial Fibrillation
Exclusion Criteria
- 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
- MI or cardiac surgery complications of cardiogenic shock and/or congestive heart failure (CHF) and/or signs/symptoms of post-procedure ischemia
- Left ventricular ejection fraction <40%
- Clinically significant depression
- Presence of implanted cardiac device
- Incomplete revascularization procedure
- Pregnancy
- Previous open-heart surgery
- Unsafe to participate in the program as per treating clinician
Data sourced from ClinicalTrials.gov (NCT05400837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.