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OpenTrials
Completed

NCT Number: NCT05400837

Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corrie Virtual Atrial Fibrillation Management Program

Combination Product

Intervention aims to implement guideline-recommended Afib care

Primary outcomes

  1. Number of Participants Who Continue Study Participation at 12 Weeks

    Time frame: 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)

Secondary outcomes

  1. Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life

    Time frame: 12 weeks

    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.

  2. Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale

    Time frame: 12 weeks

    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.

  3. Skills in Applying Electronic Health Information to Health Problems

    Time frame: 12 weeks

    Measured by 8-item questionnaire eHealth Literacy Scale. Scores range from 10-50 with a higher score indicating higher electronic health literacy.

  4. Depressive Symptoms as Assessed by the Patient Health Questionnaire 8

    Time frame: 12 weeks

    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.

  5. Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score

    Time frame: 12 weeks

    Generalized Anxiety Disorder 7 (GAD 7) - score ranges from 0 to 21 with higher scores indicating more anxiety.

  6. Stress Level as Assessed by the Perceived Stress Score

    Time frame: 12 weeks

    Measured by Perceived Stress Score (PSS-10), 10 item questionnaire where score ranges from 0-40 with higher scores indicating higher level of stress.

  7. Physical Activity as Assessed by the Rapid Assessment of Physical Activity

    Time frame: 12 weeks

    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.

  8. Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test

    Time frame: 12 weeks

    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.

  9. Diet as Assessed by the Rate Your Plate (RYP) Scale

    Time frame: 12 weeks

    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.

  10. Blood Pressure

    Time frame: 12 weeks

    Measured in millimeters of mercury (mmHg).

  11. Body Mass Index (BMI)

    Time frame: 12 weeks

    Measured in kilograms over meter squared (Kg/m^2).

  12. Satisfaction With Intervention

    Time frame: 12 weeks

    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.

Other outcomes

  1. At-home Sleep Study Results

    Time frame: Studies were completed one time between enrollment and end of treatment at 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Acronym: mTECHAFib

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2022
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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