Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction

Study Overview
=================
Brief Summary
-----------------
The pilot portion of this study is to determine the feasibility of utilizing AF CARE to provide lifestyle modification support to patients with atrial fibrillation (AF). The prospective, RCT portion of this study compare cardiovascular risk factors (CVRF), AF knowledge, AF Symptom Severity and Burden, and QOL between and within the wait list group and the AF CARE group at baseline, 3, 6, and 12 months.

Official Title
-----------------
Feasibility Study to Improve Atrial Fibrillation Outcomes Using a Digital Application for Cardiovascular Risk Reduction: Precursor to a Multicenter Randomized Trial

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: AF CARE
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 28 kg/m2 AND one additional CVRF using LS7 Access and willingness to engage in digital technology Has a valid email address and a cell phone number Able to ambulate Able to speak/read English Exclusion Criteria: Class III/IV heart failure MI or cardiac surgery in prior 3 months Severe renal/hepatic disease Active malignancy Current/recent (within 6 months) enrollment in weight loss program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot Testing<br>Patients interface with the digital application, providing feedback on usability and satisfaction. | Device: AF CARE<br>* Patients will receive personalized messages twice weekly that will include behavior recommendations for CVRF reduction and AF education based on the initially entered psychographic profile and data entered.<br>|
| Active Comparator: AF CARE plus Usual Care<br>Patients will interface with the digital application. | Device: AF CARE<br>* Patients will receive personalized messages twice weekly that will include behavior recommendations for CVRF reduction and AF education based on the initially entered psychographic profile and data entered.<br>Behavioral: Usual Care<br>* Participants will be given recommendations for CVRF reduction based on their initial American Heart Association Life Simple 7 (LS7) assessment and will be provided educational materials and be wait listed for digital app 3 months later<br>|
| Active Comparator: Usual Care then AF Care<br>After a 6 month period of usual care only, patients will interface with the digital application. | Behavioral: Usual Care<br>* Participants will be given recommendations for CVRF reduction based on their initial American Heart Association Life Simple 7 (LS7) assessment and will be provided educational materials and be wait listed for digital app 3 months later<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Text Messages That Were Reviewed |  | Baseline through month 6 | 
| Percentage of Emails Opened and Clicked Through | Percentage of emails opened, and of those opened, the percentage of emails clicked through | Baseline through month 6 | 
| Cardiovascular Risk Factor Score | The American Heart Association Life Simple 7 (LS7) is a calculated score using lab values, biometric measurements, and patient dietary responses. Score range: 0 to 10; 0 = most risk, 10 = least risk | Baseline, month 3, month 6, and month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Knowledge Related to Atrial Fibrillation | AF knowledge assessed with the Jessa AF Knowledge Score calculated from a 16 question self- reported questionnaire with a scoring range from 0-16, 16 indicating greater knowledge. | Baseline, month 3, month 6, and month 12 | 
| Change From Baseline in AF Quality of Life Score | Quality of Life assessed using a patient completed questionnaire, Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT). The AFEQT score is a combined score of 21 items; overall score range is 21 to 100, with a higher score representing greater QOL. | Baseline, month 3, month 6, and month 12 | 
| Change From Baseline in AF Symptom Severity | AF symptom severity assessed with the Atrial Fibrillation Symptoms Severity Scale (AFSS). The AFSS is a patient self-reported questionnaire that contains 21 questions, with 7 questions that provide calculated scores for AF symptom severity (0-35) with higher scores representing greater severity. | Baseline, month 3, month 6, and month 12 | 
| Change From Baseline in AF Symptom Burden | AF symptom burden assessed with the Atrial Fibrillation Symptom Severity Scale. The AFSS is a patient self-reported questionnaire that contains 21 questions that provides calculated scores for AF Burden, calculated in the following manner; AF Burden = AF frequency + AF duration + AF severity. Each of the 3 measures contribute equally to the AF burden score, and each measure ranges from 1-10 to yield Total AF Burden scores ranging from 3-30. Higher scores indicate greater AF burden. | Baseline, month 3, month 6, and month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Text Messaging, Patient Education, Psychometric