An interventional study of AF CARE and Usual Care in Atrial Fibrillation, sponsored by Stanford University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Stanford University · Not applicable, Interventional, and Supportive care
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 11 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients interface with the digital application, providing feedback on usability and satisfaction.
Device: AF CARE
Patients will interface with the digital application.
Device: AF CARE · Behavioral: Usual Care
After a 6 month period of usual care only, patients will interface with the digital application.
Behavioral: Usual Care
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.
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
Percentage of Text Messages That Were Reviewed
Time frame: 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
Time frame: 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
Time frame: Baseline, month 3, month 6, and month 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, month 3, month 6, and month 12
| Milestone | Pilot Testing | AF CARE Plus Usual Care | Usual Care Then AF Care |
|---|---|---|---|
| Started | 9 | 2 | 0 |
| Interfaced with af care digital platform | 7 | 1 | 0 |
| Completed | 7 | 1 | 0 |
| Not completed | 2 | 1 | 0 |
| Withdrew: Did not meet eligibility criteria | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Unable to enroll on platform | 1 | 0 | 0 |
| percentage of texts | Pilot Testing |
|---|---|
| Percentage of Text Messages That Were Reviewed | 29.2 (0 to 60.0) |
Percentage of emails opened, and of those opened, the percentage of emails clicked through
| percentage of emails | Pilot Testing |
|---|---|
| Emails opened | 72.2 (19 to 97) |
| Emails clicked through | 74.3 (36 to 100) |
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
| score on a scale | AF CARE Plus Usual Care |
|---|---|
| baseline | 6.5 ± 0 |
| month 3 | 8 ± 0 |
| month 6 | 6.5 ± 0 |
| month 12 | 7 ± 0 |
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.
| score on a scale | AF CARE Plus Usual Care |
|---|---|
| baseline | 12 ± 0 |
| month 3 | 11 ± 0 |
| month 6 | 15 ± 0 |
| month 12 | 15 ± 0 |
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.
| score on a scale | AF CARE Plus Usual Care |
|---|---|
| baseline | 82 ± 0 |
| month 3 | 65 ± 0 |
| month 6 | 67 ± 0 |
| month 12 | 51 ± 0 |
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.
| score on a scale | AF CARE Plus Usual Care |
|---|---|
| baseline | 0 ± 0 |
| month 3 | 15 ± 0 |
| month 6 | 21 ± 0 |
| month 12 | 23 ± 0 |
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.
| score on a scale | AF CARE Plus Usual Care |
|---|---|
| baseline | 2 ± 0 |
| month 3 | 16 ± 0 |
| month 6 | 19 ± 0 |
| month 12 | 22 ± 0 |
Collected over Up to 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pilot Testing | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| AF CARE Plus Usual Care | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Pilot Testing | AF CARE Plus Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 1 | 6 |
| >=65 years | 4 | 1 | 5 |
| Sex: Female, Male(Participants) | Pilot Testing | AF CARE Plus Usual Care | Total |
|---|---|---|---|
| Female | 5 | 2 | 7 |
| Male | 4 | 0 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Pilot Testing | AF CARE Plus Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 9 | 2 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pilot Testing | AF CARE Plus Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 6 | 2 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(Participants) | Pilot Testing | AF CARE Plus Usual Care | Total |
|---|---|---|---|
| United States | 9 | 2 | 11 |
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