Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management

Study Overview
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Brief Summary
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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).

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

Conditions
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Atrial Fibrillation, Behavior

Intervention / Treatment
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* Combination Product: Corrie Virtual Atrial Fibrillation Management Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 18 years or older Non- valvular Paroxysmal Atrial Fibrillation diagnosed not more than 12 months prior to randomization 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as assessed by the retention rate | Retention rate at 3 months (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion) divided by the number of individuals who consent to participation in the study at 3 months after enrollment. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Severity as assessed by the Atrial Fibrillation Severity Scale | Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire. | 12 weeks | 
| Social Support as assessed by the Medical Outcomes Social Support Survey Instrument | Measured by Medical Outcomes Social Support Survey Instrument (MOS Social Support Scale) - 19 item questionnaire with final score ranging between 0 - 100 with higher scores suggesting more support. | 12 weeks | 
| Skills in applying electronic health information to health problems | Measured by 8-item questionnaire eHealth Literacy Scale. | 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). | 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 | 
| Atrial Fibrillation Episode Burden | As assessed by the ratio of the number of 30 second single lead electrocardiogram(ECG) recordings with Afib divided by total number of 30 second single lead ECG recordings. | 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). | 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 | 
| Smoking status as assessed by study team developed questionnaire | Smoking status will be assessed by a study team developed questionnaire. | 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: 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: You are making many healthy choices. | 12 weeks | 
| Blood pressure | Measured in millimeters of mercury (mmHg). | 12 weeks | 
| Body Mass Index (BMI) | Measured in kilograms over meter squared (Kg/m^2). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote Patient Monitoring, Atrial Fibrillation, Risk Factor Modification, Digital Health, Mobile Health