Feasibility Study to Improve Atrial Fibrillation Outcomes Using a Digital Application for Cardiovascular Risk Reduction: Precursor to a Multicenter Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Stanford University
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Percentage of Emails Opened and Clicked Through
- Status
- Terminated
- Last Updated
- 2 years ago
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.
Investigators
Paul Wang
Director, Stanford Electrophysiology and Arrhythmia Service
Stanford University
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
Outcomes
Primary Outcomes
Percentage of Emails Opened and Clicked Through
Time Frame: Baseline through month 6
Percentage of emails opened, and of those opened, the percentage of emails clicked through
Percentage of Text Messages That Were Reviewed
Time Frame: Baseline through month 6
Cardiovascular Risk Factor Score
Time Frame: Baseline, month 3, month 6, and month 12
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
Secondary Outcomes
- Change From Baseline in AF Symptom Severity(Baseline, month 3, month 6, and month 12)
- Change From Baseline in AF Symptom Burden(Baseline, month 3, month 6, and month 12)
- Change From Baseline in Knowledge Related to Atrial Fibrillation(Baseline, month 3, month 6, and month 12)
- Change From Baseline in AF Quality of Life Score(Baseline, month 3, month 6, and month 12)