Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction
- Conditions
- Atrial Fibrillation
- Interventions
- Device: AF CAREBehavioral: Usual Care
- Registration Number
- NCT04050982
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AF CARE plus Usual Care AF CARE Patients will interface with the digital application. AF CARE plus Usual Care Usual Care Patients will interface with the digital application. Pilot Testing AF CARE Patients interface with the digital application, providing feedback on usability and satisfaction. Usual Care then AF Care Usual Care After a 6 month period of usual care only, patients will interface with the digital application.
- Primary Outcome Measures
Name Time Method Percentage of Emails Opened and Clicked Through 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 Baseline through month 6 Cardiovascular Risk Factor Score 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 Outcome Measures
Name Time Method Change From Baseline in AF Symptom Severity Baseline, month 3, month 6, and month 12 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.
Change From Baseline in AF Symptom Burden Baseline, month 3, month 6, and month 12 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.
Change From Baseline in Knowledge Related to Atrial Fibrillation Baseline, month 3, month 6, and month 12 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.
Change From Baseline in AF Quality of Life Score Baseline, month 3, month 6, and month 12 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.
Trial Locations
- Locations (1)
Stanford Health Care
🇺🇸Stanford, California, United States