Clinical trial NCT05400837: Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management
Official title: Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management: A Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Behavior
Keywords: Remote Patient Monitoring
Atrial Fibrillation
Risk Factor Modification
Digital Health
Mobile Health
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).


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

Primary outcomes:
measure: Feasibility as assessed by the retention rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life as assessed by the Atrial Fibrillation Effect on Quality-of-Life
timeFrame: 12 weeks
measure: Atrial Fibrillation Severity as assessed by the Atrial Fibrillation Severity Scale
timeFrame: 12 weeks
measure: Social Support as assessed by the Medical Outcomes Social Support Survey Instrument
timeFrame: 12 weeks
measure: Skills in applying electronic health information to health problems
timeFrame: 12 weeks
measure: Depressive symptoms as assessed by the Patient Health Questionnaire 8
timeFrame: 12 weeks
measure: Anxiety as assessed by the Generalized Anxiety Disorder 7 score
timeFrame: 12 weeks
measure: Stress level as assessed by the Perceived Stress Score
timeFrame: 12 weeks
measure: Physical Activity as assessed by the Rapid Assessment of Physical Activity
timeFrame: 12 weeks
measure: Alcohol use as assessed by the Alcohol Use Disorders Identification Test
timeFrame: 12 weeks
measure: Smoking status as assessed by study team developed questionnaire
timeFrame: 12 weeks
measure: Diet as assessed by the Rate Your Plate (RYP) scale
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Body Mass Index (BMI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: David Spragg, MD
role: PRINCIPAL_INVESTIGATOR
References: