Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management (mTECHAFib)

Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management: A Pilot Randomized Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Behavior
• Intervention / Treatment: Combination product: Corrie Virtual Atrial Fibrillation Management Program

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Experimental: Corrie Virtual Atrial Fibrillation Management Program; Multicomponent virtual atrial fibrillation management program	Combination product: Corrie Virtual Atrial Fibrillation Management Program; Intervention aims to implement guideline-recommended Afib care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Continue Study Participation at 12 Weeks	Feasibility assessed by retention at 12 weeks (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	Measured in kilograms over meter squared (Kg/m^2).	12 weeks
Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life	Measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT), which consists of 20 items. Score ranges from 0 to 100 with higher scores signifying better quality of life.	12 weeks
Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale	Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire. Includes 5 subscores. AF burden is the sum of AF duration, AF severity, and AF frequency, and ranges from 3 to 30, with 30 being highest burden. AF duration, severity, and frequency each range from 1 to 10. The final subscore is AF symptoms, which ranges from 0-35 with 35 indicating worst possible symptoms.	12 weeks
Skills in Applying Electronic Health Information to Health Problems	Measured by 8-item questionnaire eHealth Literacy Scale. Scores range from 10-50 with a higher score indicating higher electronic health literacy.	12 weeks
Depressive Symptoms as Assessed by the Patient Health Questionnaire 8	Measured by Patient Health Questionnaire 8 (PHQ - 8) - 8-item measure with (≤4: no depressive symptom, 5-9: mild, ≥10: moderate to severe depressive symptoms). Score range 0-27 with higher score indicating more depressive symptoms.	12 weeks
Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score	Generalized Anxiety Disorder 7 (GAD 7) - score ranges from 0 to 21 with higher scores indicating more anxiety.	12 weeks
Stress Level as Assessed by the Perceived Stress Score	Measured by Perceived Stress Score (PSS-10), 10 item questionnaire where score ranges from 0-40 with higher scores indicating higher level of stress.	12 weeks
Physical Activity as Assessed by the Rapid Assessment of Physical Activity	Physical Activity will be assessed by The Rapid Assessment of Physical Activity (RAPA). Part 1 scores range from 1-5 with increasing scores indicating higher levels of activity, 5 being optimal. Part 2 is scored from 0-3 and measures the amount of flexibility and calisthenics exercise a person completes, with 3 being optimal.	12 weeks
Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test	As assessed by The Alcohol Use Disorders Identification Test (AUDIT), 10-item questionnaire. The score range is from 0 to 40 with 0 referring to abstainer with no history of alcohol abuse and higher scores indicate gradually higher and hazardous alcohol dependence.	12 weeks
Diet as Assessed by the Rate Your Plate (RYP) Scale	Measured by Rate Your Plate (RYP) scale. A 27 item scale administered at 12 weeks with the following scoring system: Score ranges from 27-81. Score of 27-45: There are many ways you can make your eating habits healthier. 46-63: There are some ways you can make your eating habits healthier. 64-81: Higher score indicates participant is making many healthy choices.	12 weeks
Blood Pressure	Measured in millimeters of mercury (mmHg).	12 weeks
Satisfaction With Intervention	Measured by the System Usability Scale (SUS), modified for the intervention. The SUS score ranges from 0-100, where 0 is "worst imaginable" and 100 is "best imaginable." The average score is 68.0, a good score is between 71.4-85.4. 85.5 and above is considered excellent. Higher score more satisfaction.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
At-home Sleep Study Results	Patients completed an at-home sleep study and received a diagnosis of no sleep apnea, mild sleep apnea, moderate sleep apnea, or severe sleep apnea, based on their AHI (apnea-hypopnea index). AHI is measured in breathing disturbance events per hour. An AHI <5 indicates no sleep apnea, from 5-15 is mild, 16-30 is moderate, and >30 is severe sleep apnea.	Studies were completed one time between enrollment and end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: David Spragg, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Actual): May 23, 2024
• Study Completion (Actual): May 23, 2024

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Mobile Health; Digital Health; Remote Patient Monitoring; Risk Factor Modification
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: IRB00321575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No