Atrial Fibrillation
Conditions
Keywords
Text Messaging, Patient Education, Psychometric
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.
Interventions
DEVICEAF 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.
BEHAVIORALUsual Care
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
Sponsors
American Heart Association
PatientBond
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Text Messages That Were Reviewed | Baseline through month 6 | — |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pilot Testing Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction. | 9 |
| AF CARE Plus Usual Care Patients interface with the AF CARE digital platform and receive usual care. | 2 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not meet eligibility criteria | 0 | 1 | 0 |
| Overall Study | Unable to enroll on platform | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Pilot Testing | AF CARE Plus Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 2 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 6 Participants | 2 Participants | 8 Participants |
| Region of Enrollment United States | 9 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 2 |
| other Total, other adverse events | 0 / 9 | 0 / 2 |
| serious Total, serious adverse events | 0 / 9 | 0 / 2 |
Outcome results
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
Time frame: Baseline, month 3, month 6, and month 12
Population: Data for this outcome measure were collected only in the AF CARE plus Usual Care group. Only participants who interfaced with the AF CARE platform are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Testing | Cardiovascular Risk Factor Score | month 3 | 8 score on a scale | Standard Deviation 0 |
| Pilot Testing | Cardiovascular Risk Factor Score | baseline | 6.5 score on a scale | Standard Deviation 0 |
| Pilot Testing | Cardiovascular Risk Factor Score | month 6 | 6.5 score on a scale | Standard Deviation 0 |
| Pilot Testing | Cardiovascular Risk Factor Score | month 12 | 7 score on a scale | Standard Deviation 0 |
Primary
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
Population: Data for this outcome measure were collected only in the Pilot Testing group. Only participants who interfaced with the AF CARE platform are included.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pilot Testing | Percentage of Emails Opened and Clicked Through | Emails opened | 72.2 percentage of emails |
| Pilot Testing | Percentage of Emails Opened and Clicked Through | Emails clicked through | 74.3 percentage of emails |
Primary
Percentage of Text Messages That Were Reviewed
Time frame: Baseline through month 6
Population: Data for this outcome measure were collected only in the Pilot Testing group. Only participants who interfaced with the AF CARE platform are included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pilot Testing | Percentage of Text Messages That Were Reviewed | 29.2 percentage of texts |
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.
Time frame: Baseline, month 3, month 6, and month 12
Population: Data for this outcome measure were collected only in the AF CARE plus Usual Care group. Only participants who interfaced with the AF CARE platform are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Testing | Change From Baseline in AF Quality of Life Score | month 3 | 65 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in AF Quality of Life Score | baseline | 82 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in AF Quality of Life Score | month 6 | 67 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in AF Quality of Life Score | month 12 | 51 score on a scale | Standard Deviation 0 |
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.
Time frame: Baseline, month 3, month 6, and month 12
Population: Data for this outcome measure were collected only in the AF CARE plus Usual Care group. Only participants who interfaced with the AF CARE platform are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Testing | Change From Baseline in AF Symptom Burden | baseline | 2 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in AF Symptom Burden | month 3 | 16 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in AF Symptom Burden | month 6 | 19 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in AF Symptom Burden | month 12 | 22 score on a scale | Standard Deviation 0 |
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.
Time frame: Baseline, month 3, month 6, and month 12
Population: Data for this outcome measure were collected only in the AF CARE plus Usual Care group. Only participants who interfaced with the AF CARE platform are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Testing | Change From Baseline in AF Symptom Severity | baseline | 0 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in AF Symptom Severity | month 3 | 15 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in AF Symptom Severity | month 6 | 21 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in AF Symptom Severity | month 12 | 23 score on a scale | Standard Deviation 0 |
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.
Time frame: Baseline, month 3, month 6, and month 12
Population: Data for this outcome measure were collected only in the AF CARE plus Usual Care group. Only participants who interfaced with the AF CARE platform are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Testing | Change From Baseline in Knowledge Related to Atrial Fibrillation | baseline | 12 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in Knowledge Related to Atrial Fibrillation | month 3 | 11 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in Knowledge Related to Atrial Fibrillation | month 6 | 15 score on a scale | Standard Deviation 0 |
| Pilot Testing | Change From Baseline in Knowledge Related to Atrial Fibrillation | month 12 | 15 score on a scale | Standard Deviation 0 |