Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management

Not Applicable

Completed

Conditions: Atrial Fibrillation
Behavior

Registration Number: NCT05400837

Lead Sponsor: Johns Hopkins University

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Continue Study Participation at 12 Weeks	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 Outcome Measures

Name	Time	Method
Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale	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.
Stress Level as Assessed by the Perceived Stress Score	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.
Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life	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.
Depressive Symptoms as Assessed by the Patient Health Questionnaire 8	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.
Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test	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.
Body Mass Index (BMI)	12 weeks	Measured in kilograms over meter squared (Kg/m\^2).
Physical Activity as Assessed by the Rapid Assessment of Physical Activity	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.
Satisfaction With Intervention	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.
Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score	12 weeks	Generalized Anxiety Disorder 7 (GAD 7) - score ranges from 0 to 21 with higher scores indicating more anxiety.
Diet as Assessed by the Rate Your Plate (RYP) Scale	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.
Skills in Applying Electronic Health Information to Health Problems	12 weeks	Measured by 8-item questionnaire eHealth Literacy Scale. Scores range from 10-50 with a higher score indicating higher electronic health literacy.
Blood Pressure	12 weeks	Measured in millimeters of mercury (mmHg).