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Acquisition of digital messaging company and decision made to withdraw study support
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| PatientBond | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Testing | Experimental | Patients interface with the digital application, providing feedback on usability and satisfaction. |
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| AF CARE plus Usual Care | Active Comparator | Patients will interface with the digital application. |
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| Usual Care then AF Care | Active Comparator | After a 6 month period of usual care only, patients will interface with the digital application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AF CARE | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Text Messages That Were Reviewed | 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 | 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 | Baseline, month 3, month 6, and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change From Baseline in AF Quality of Life Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Ottoboni, PhD | Clinician and research scientist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Testing | Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction. |
| FG001 | AF CARE Plus Usual Care | Patients interface with the AF CARE digital platform and receive usual care. |
| FG002 | Usual Care Then AF Care | After a 6 month period of usual care only, patients will interface with the AF CARE digital platform. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Testing | Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction. |
| BG001 | AF CARE Plus Usual Care | Patients interface with the AF CARE digital platform and receive usual care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Text Messages That Were Reviewed | Data for this outcome measure were collected only in the Pilot Testing group. Only participants who interfaced with the AF CARE platform are included. | Posted | Mean | Full Range | percentage of texts | Baseline through month 6 |
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Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pilot Testing | Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction. |
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The study did not meet its planned enrollment size, and did not achieve statistical power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Ottoboni | Stanford University | (650) 498-5914 | LOttoboni@stanfordhealthcare.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2022 | Apr 21, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Randomized control trial
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| Usual Care | Behavioral | 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 |
|
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 |
| 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 |
| 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 |
| Unable to enroll on platform |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Percentage of Emails Opened and Clicked Through | Percentage of emails opened, and of those opened, the percentage of emails clicked through | Data for this outcome measure were collected only in the Pilot Testing group. Only participants who interfaced with the AF CARE platform are included. | Posted | Mean | Full Range | percentage of emails | Baseline through month 6 |
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|
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, month 3, month 6, and month 12 |
|
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, month 3, month 6, and month 12 |
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|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, month 3, month 6, and month 12 |
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|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | AF CARE Plus Usual Care | Patients interface with the AF CARE digital platform and receive usual care. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| month 12 |
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| Title | Measurements |
|---|---|
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| month 12 |
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| Title | Measurements |
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| month 12 |
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| Title | Measurements |
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| month 12 |
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| Title | Measurements |
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| month 12 |
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