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The overall objective of this proposal is to evaluate the feasibility of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.
Researchers plan to evaluate the feasibility and preliminary efficacy of this novel digital toolkit in improving quality of life and decreasing AFib burden in a pilot randomized clinical trial (RCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Experimental | Multicomponent virtual atrial fibrillation management program |
|
| Usual Care | No Intervention | Receives usual care. Usual care is defined as care according to the patients care team's standard practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Combination Product | Intervention aims to implement guideline-recommended Afib care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Continue Study Participation at 12 Weeks | Feasibility assessed by retention at 12 weeks (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life | Measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT), which consists of 20 items. Score ranges from 0 to 100 with higher scores signifying better quality of life. | 12 weeks |
| Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale |
| Measure | Description | Time Frame |
|---|---|---|
| At-home Sleep Study Results | Patients completed an at-home sleep study and received a diagnosis of no sleep apnea, mild sleep apnea, moderate sleep apnea, or severe sleep apnea, based on their AHI (apnea-hypopnea index). AHI is measured in breathing disturbance events per hour. An AHI <5 indicates no sleep apnea, from 5-15 is mild, 16-30 is moderate, and >30 is severe sleep apnea. | Studies were completed one time between enrollment and end of treatment at 12 weeks |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| David Spragg, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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Participants were assigned their group immediately after signing consent.
Participants were recruited from outpatient electrophysiology clinics at Johns Hopkins Hospital. A study coordinator reviewed EMRs and let clinicians know which patients were eligible. The clinician introduced the patient to the study, and if they were interested, the study coordinator talked to the patient after their appointment. Interested patients signed informed consent, were randomized, and onboarded to the study the same day.
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| ID | Title | Description |
|---|---|---|
| FG000 | Corrie Virtual Atrial Fibrillation Management Program | Multicomponent virtual atrial fibrillation management program |
| FG001 | Usual Care | Receives usual care. Usual care is defined as care according to the patients care team's standard practice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data was excluded for one participant who asked to have their data deleted from the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Corrie Virtual Atrial Fibrillation Management Program | Multicomponent virtual atrial fibrillation management program |
| BG001 | Usual Care | Receives usual care. Usual care is defined as care according to the patients care team's standard practice |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data was excluded for one participant who asked to have their data deleted from the study. |
| 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 | Number of Participants Who Continue Study Participation at 12 Weeks | Feasibility assessed by retention at 12 weeks (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion) | Posted | Count of Participants | Participants | 12 weeks |
|
From enrollment until end of follow-up, up to 12 weeks
The investigators asked participants to report any adverse events up to the end of follow-up (12 weeks). Adverse events were adjudicated by the principal investigator.
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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 | Corrie Virtual Atrial Fibrillation Management Program | Multicomponent virtual atrial fibrillation management program Corrie Virtual Atrial Fibrillation Management Program: Intervention aims to implement guideline-recommended Afib care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nino Isakadze | Johns Hopkins University | 443-997-0270 | nisakad1@jh.edu |
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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 | Aug 25, 2023 | May 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire. Includes 5 subscores. AF burden is the sum of AF duration, AF severity, and AF frequency, and ranges from 3 to 30, with 30 being highest burden. AF duration, severity, and frequency each range from 1 to 10. The final subscore is AF symptoms, which ranges from 0-35 with 35 indicating worst possible symptoms. |
| 12 weeks |
| Skills in Applying Electronic Health Information to Health Problems | Measured by 8-item questionnaire eHealth Literacy Scale. Scores range from 10-50 with a higher score indicating higher electronic health literacy. | 12 weeks |
| Depressive Symptoms as Assessed by the Patient Health Questionnaire 8 | Measured by Patient Health Questionnaire 8 (PHQ - 8) - 8-item measure with (≤4: no depressive symptom, 5-9: mild, ≥10: moderate to severe depressive symptoms). Score range 0-27 with higher score indicating more depressive symptoms. | 12 weeks |
| Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score | Generalized Anxiety Disorder 7 (GAD 7) - score ranges from 0 to 21 with higher scores indicating more anxiety. | 12 weeks |
| Stress Level as Assessed by the Perceived Stress Score | Measured by Perceived Stress Score (PSS-10), 10 item questionnaire where score ranges from 0-40 with higher scores indicating higher level of stress. | 12 weeks |
| Physical Activity as Assessed by the Rapid Assessment of Physical Activity | Physical Activity will be assessed by The Rapid Assessment of Physical Activity (RAPA). Part 1 scores range from 1-5 with increasing scores indicating higher levels of activity, 5 being optimal. Part 2 is scored from 0-3 and measures the amount of flexibility and calisthenics exercise a person completes, with 3 being optimal. | 12 weeks |
| Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test | As assessed by The Alcohol Use Disorders Identification Test (AUDIT), 10-item questionnaire. The score range is from 0 to 40 with 0 referring to abstainer with no history of alcohol abuse and higher scores indicate gradually higher and hazardous alcohol dependence. | 12 weeks |
| Diet as Assessed by the Rate Your Plate (RYP) Scale | Measured by Rate Your Plate (RYP) scale. A 27 item scale administered at 12 weeks with the following scoring system: Score ranges from 27-81. Score of 27-45: There are many ways you can make your eating habits healthier. 46-63: There are some ways you can make your eating habits healthier. 64-81: Higher score indicates participant is making many healthy choices. | 12 weeks |
| Blood Pressure | Measured in millimeters of mercury (mmHg). | 12 weeks |
| Body Mass Index (BMI) | Measured in kilograms over meter squared (Kg/m^2). | 12 weeks |
| Satisfaction With Intervention | Measured by the System Usability Scale (SUS), modified for the intervention. The SUS score ranges from 0-100, where 0 is "worst imaginable" and 100 is "best imaginable." The average score is 68.0, a good score is between 71.4-85.4. 85.5 and above is considered excellent. Higher score more satisfaction. | 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Data was excluded for one participant who asked to have their data deleted from the study. | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Data was excluded for one participant who asked to have their data deleted from the study. | Count of Participants | Participants | No |
|
| Quality of life as assessed by the Atrial Fibrillation Effect on Quality-of-Life | Measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT), which consists of 20 items. Score ranges from 0 to 100 with higher scores signifying better quality of life. | Some participants chose not to complete this questionnaire. | Mean | Standard Deviation | Survey score |
|
| Atrial Fibrillation (AF) Severity as assessed by the Atrial Fibrillation Severity Scale | Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire. Includes 5 subscores. AF burden is the sum of AF duration, AF severity, and AF frequency, and ranges from 3 to 30, with 30 being highest burden. AF duration, severity, and frequency each range from 1 to 10. The final subscore is AF symptoms, which ranges from 0-35 with 35 indicating worst possible symptoms. | Some participants chose not to complete this questionnaire | Mean | Standard Deviation | Survey score |
|
| Skills in applying electronic health information to health problems | Measured by 10-item questionnaire eHealth Literacy Scale. Scores range from 10-50 with a higher score indicating higher electronic health information literacy. | Some participants chose not to complete this questionnaire | Mean | Standard Deviation | Survey score |
|
| Depressive symptoms as assessed by the Patient Health Questionnaire 8 | Measured by Patient Health Questionnaire 8 (PHQ - 8) - 8-item measure with (≤4: no depressive symptom, 5-9: mild, ≥10: moderate to severe depressive symptoms). Score range 0-27, higher score more depressive symptoms. | Some participants chose not to complete this questionnaire | Mean | Standard Deviation | Survey score |
|
| Anxiety as assessed by the Generalized Anxiety Disorder 7 score | Generalized Anxiety Disorder 7 (GAD 7) - score ranges from 0 to 21 with higher scores indicating more anxiety. | Some participants chose not to complete this questionnaire | Mean | Standard Deviation | Survey score |
|
| Stress level as assessed by the Perceived Stress Score | Measured by Perceived Stress Score (PSS-10), 10 item questionnaire where score ranges from 0-40 with higher scores indicating higher level of stress. | Some participants chose not to complete this questionnaire | Mean | Standard Deviation | Survey score |
|
| Alcohol use as assessed by the Alcohol Use Disorders Identification Test | As assessed by The Alcohol Use Disorders Identification Test (AUDIT), 10-item questionnaire. The score range is from 0 to 40 with 0 referring to abstainer with no history of alcohol abuse and higher scores indicate gradually higher and hazardous alcohol dependence. | Some participants chose not to complete this questionnaire | Mean | Standard Deviation | Survey score |
|
| Physical Activity as assessed by the Rapid Assessment of Physical Activity | Physical Activity will be assessed by The Rapid Assessment of Physical Activity (RAPA). Part 1 is scored from 1 to 5 where 5 is the optimal level of physical activity, and 1 is completely sedentary. Part 2 measures flexibility/calisthenics exercise frequency and is scored from 0-3 where 3 is optimal. | Some participants chose not to complete this questionnaire | Mean | Standard Deviation | Survey score |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life | Measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT), which consists of 20 items. Score ranges from 0 to 100 with higher scores signifying better quality of life. | Some participants chose not to complete this survey. | Posted | Median | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire. Includes 5 subscores. AF burden is the sum of AF duration, AF severity, and AF frequency, and ranges from 3 to 30, with 30 being highest burden. AF duration, severity, and frequency each range from 1 to 10. The final subscore is AF symptoms, which ranges from 0-35 with 35 indicating worst possible symptoms. | Some participants chose not to complete this survey | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Skills in Applying Electronic Health Information to Health Problems | Measured by 8-item questionnaire eHealth Literacy Scale. Scores range from 10-50 with a higher score indicating higher electronic health literacy. | Some participants chose not to complete this survey | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Depressive Symptoms as Assessed by the Patient Health Questionnaire 8 | Measured by Patient Health Questionnaire 8 (PHQ - 8) - 8-item measure with (≤4: no depressive symptom, 5-9: mild, ≥10: moderate to severe depressive symptoms). Score range 0-27 with higher score indicating more depressive symptoms. | Some participants chose not to complete this survey | Posted | Mean | Standard Deviation | Survey score | 12 weeks |
|
|
|
| Secondary | Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score | Generalized Anxiety Disorder 7 (GAD 7) - score ranges from 0 to 21 with higher scores indicating more anxiety. | Some participants chose not to complete this survey | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Stress Level as Assessed by the Perceived Stress Score | Measured by Perceived Stress Score (PSS-10), 10 item questionnaire where score ranges from 0-40 with higher scores indicating higher level of stress. | Some participants chose not to complete this survey | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Physical Activity as Assessed by the Rapid Assessment of Physical Activity | Physical Activity will be assessed by The Rapid Assessment of Physical Activity (RAPA). Part 1 scores range from 1-5 with increasing scores indicating higher levels of activity, 5 being optimal. Part 2 is scored from 0-3 and measures the amount of flexibility and calisthenics exercise a person completes, with 3 being optimal. | Some participants chose not to complete this survey | Posted | Mean | Standard Deviation | Survey score | 12 weeks |
|
|
|
| Secondary | Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test | As assessed by The Alcohol Use Disorders Identification Test (AUDIT), 10-item questionnaire. The score range is from 0 to 40 with 0 referring to abstainer with no history of alcohol abuse and higher scores indicate gradually higher and hazardous alcohol dependence. | Some participants chose not to complete this survey | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Diet as Assessed by the Rate Your Plate (RYP) Scale | Measured by Rate Your Plate (RYP) scale. A 27 item scale administered at 12 weeks with the following scoring system: Score ranges from 27-81. Score of 27-45: There are many ways you can make your eating habits healthier. 46-63: There are some ways you can make your eating habits healthier. 64-81: Higher score indicates participant is making many healthy choices. | Some participants chose not to complete this survey | Posted | Mean | Standard Deviation | Survey score | 12 weeks |
|
|
|
| Secondary | Blood Pressure | Measured in millimeters of mercury (mmHg). | Some participants did not complete the 12-week follow-up visit where blood pressure was assessed. | Posted | Mean | Standard Deviation | mmHg | 12 weeks |
|
|
|
| Secondary | Body Mass Index (BMI) | Measured in kilograms over meter squared (Kg/m^2). | Not all participants completed the 12-week follow-up visit where weight was measured. | Posted | Mean | Standard Deviation | kg/m^2 | 12 weeks |
|
|
|
| Secondary | Satisfaction With Intervention | Measured by the System Usability Scale (SUS), modified for the intervention. The SUS score ranges from 0-100, where 0 is "worst imaginable" and 100 is "best imaginable." The average score is 68.0, a good score is between 71.4-85.4. 85.5 and above is considered excellent. Higher score more satisfaction. | Participants in usual care did not receive intervention and so did not rate their satisfaction. Not all participants in the intervention chose to complete the survey. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks |
|
|
|
| Other Pre-specified | At-home Sleep Study Results | Patients completed an at-home sleep study and received a diagnosis of no sleep apnea, mild sleep apnea, moderate sleep apnea, or severe sleep apnea, based on their AHI (apnea-hypopnea index). AHI is measured in breathing disturbance events per hour. An AHI <5 indicates no sleep apnea, from 5-15 is mild, 16-30 is moderate, and >30 is severe sleep apnea. | The control group did not complete a sleep study. Not all members of the intervention group chose to complete the sleep study. | Posted | Count of Participants | Participants | Studies were completed one time between enrollment and end of treatment at 12 weeks |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| 4 |
| 30 |
| EG001 | Usual Care | Receives usual care. Usual care is defined as care according to the patients care team's standard practice | 0 | 31 | 0 | 31 | 5 | 31 |
| Emergency department visit | General disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| AF severity score |
|
| AF frequency score |
|
| AF symptoms score |
|
| Not diagnosed with sleep apnea |
|