Atrial Fibrillation Clinical Trial
— AFCAREOfficial title:
Feasibility Study to Improve Atrial Fibrillation Outcomes Using a Digital Application for Cardiovascular Risk Reduction: Precursor to a Multicenter Randomized Trial
Verified date | August 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 11 |
Est. completion date | January 26, 2023 |
Est. primary completion date | January 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. BMI > 28 kg/m2 AND one additional CVRF using LS7 2. Access and willingness to engage in digital technology 3. Has a valid email address and a cell phone number 4. Able to ambulate 5. Able to speak/read English Exclusion Criteria: 1. Class III/IV heart failure 2. MI or cardiac surgery in prior 3 months 3. Severe renal/hepatic disease 4. Active malignancy 5. Current/recent (within 6 months) enrollment in weight loss program |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Health Care | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | American Heart Association, PatientBond |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Text Messages That Were Reviewed | Baseline through month 6 | ||
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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