Atrial Fibrillation, Behavior
Conditions
Keywords
Remote Patient Monitoring, Atrial Fibrillation, Risk Factor Modification, Digital Health, Mobile Health
Brief summary
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).
Interventions
COMBINATION_PRODUCTCorrie Virtual Atrial Fibrillation Management Program
Intervention aims to implement guideline-recommended Afib care
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Non- valvular Paroxysmal Atrial Fibrillation
Exclusion criteria
* Non-English speaking * Has previously been evaluated by a cardiologist or electrophysiologist * Mitral Stenosis * Presence of Artificial Heart Valve * Severe valvular disease (any) * Physical disability that would preclude technology use, safe and adequate exercise performance * Hearing or Visual Impairment that would preclude technology use * History of fall one or more times in the last year * Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of \>25 mmHg * Known aortic dissection * Severe resting arterial hypertension (SBP \>200 mmHg or diastolic BP \>110mmHg) upon enrollment (obtained during clinic visit) * Mental impairment leading to inability to cooperate with study procedures * Untreated high degree atrioventricular block * Atrial fibrillation with rapid ventricular rate (Resting heart rate at enrollment visit \>110) upon enrollment (obtained during clinic visit) * History of cardiac arrest, sudden death * MI or cardiac surgery complications of cardiogenic shock and/or congestive heart failure (CHF) and/or signs/symptoms of post-procedure ischemia * Left ventricular ejection fraction \<40% * Clinically significant depression * Presence of implanted cardiac device * Incomplete revascularization procedure * Pregnancy * Previous open-heart surgery * Unsafe to participate in the program as per treating clinician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Continue Study Participation at 12 Weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | 12 weeks | 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. |
| Skills in Applying Electronic Health Information to Health Problems | 12 weeks | Measured by 8-item questionnaire eHealth Literacy Scale. Scores range from 10-50 with a higher score indicating higher electronic health literacy. |
| Depressive Symptoms as Assessed by the Patient Health Questionnaire 8 | 12 weeks | 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. |
| Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score | 12 weeks | Generalized Anxiety Disorder 7 (GAD 7) - score ranges from 0 to 21 with higher scores indicating more anxiety. |
| Stress Level as Assessed by the Perceived Stress Score | 12 weeks | Measured by Perceived Stress Score (PSS-10), 10 item questionnaire where score ranges from 0-40 with higher scores indicating higher level of stress. |
| Physical Activity as Assessed by the Rapid Assessment of Physical Activity | 12 weeks | 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. |
| Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life | 12 weeks | 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. |
| Diet as Assessed by the Rate Your Plate (RYP) Scale | 12 weeks | 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. |
| Blood Pressure | 12 weeks | Measured in millimeters of mercury (mmHg). |
| Body Mass Index (BMI) | 12 weeks | Measured in kilograms over meter squared (Kg/m\^2). |
| Satisfaction With Intervention | 12 weeks | 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. |
| Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test | 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| At-home Sleep Study Results | Studies were completed one time between enrollment and end of treatment at 12 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Participants were assigned their group immediately after signing consent.
Participants by arm
| Arm | Count |
|---|---|
| Corrie Virtual Atrial Fibrillation Management Program Multicomponent virtual atrial fibrillation management program | 30 |
| Usual Care Receives usual care. Usual care is defined as care according to the patients care team's standard practice | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | Corrie Virtual Atrial Fibrillation Management Program | Usual Care |
|---|---|---|---|
| Age, Continuous | 67.5 years | 65 years | 69 years |
| Alcohol use as assessed by the Alcohol Use Disorders Identification Test | 2.0 Survey score STANDARD_DEVIATION 2.8 | 2.0 Survey score STANDARD_DEVIATION 2.5 | 2.0 Survey score STANDARD_DEVIATION 3 |
| Anxiety as assessed by the Generalized Anxiety Disorder 7 score | 1.1 Survey score STANDARD_DEVIATION 4 | 0 Survey score STANDARD_DEVIATION 4 | 2.0 Survey score STANDARD_DEVIATION 4 |
| Atrial Fibrillation (AF) Severity as assessed by the Atrial Fibrillation Severity Scale AF burden subscore | 13.0 Survey score STANDARD_DEVIATION 4.5 | 12.8 Survey score STANDARD_DEVIATION 5.4 | 13.2 Survey score STANDARD_DEVIATION 3.7 |
| Atrial Fibrillation (AF) Severity as assessed by the Atrial Fibrillation Severity Scale AF duration subscore | 4.2 Survey score STANDARD_DEVIATION 2.4 | 4.1 Survey score STANDARD_DEVIATION 2.8 | 4.3 Survey score STANDARD_DEVIATION 2.1 |
| Atrial Fibrillation (AF) Severity as assessed by the Atrial Fibrillation Severity Scale AF frequency subscore | 3.2 Survey score STANDARD_DEVIATION 2.5 | 3.0 Survey score STANDARD_DEVIATION 3 | 3.4 Survey score STANDARD_DEVIATION 1.8 |
| Atrial Fibrillation (AF) Severity as assessed by the Atrial Fibrillation Severity Scale AF severity subscore | 5.4 Survey score STANDARD_DEVIATION 2.5 | 5.3 Survey score STANDARD_DEVIATION 2.7 | 5.4 Survey score STANDARD_DEVIATION 2.3 |
| Atrial Fibrillation (AF) Severity as assessed by the Atrial Fibrillation Severity Scale AF symptoms subscore | 7.2 Survey score STANDARD_DEVIATION 6 | 6.3 Survey score STANDARD_DEVIATION 5.3 | 7.9 Survey score STANDARD_DEVIATION 6.5 |
| Depressive symptoms as assessed by the Patient Health Questionnaire 8 | 1.6 Survey score STANDARD_DEVIATION 5 | 1.0 Survey score STANDARD_DEVIATION 5 | 2.0 Survey score STANDARD_DEVIATION 5 |
| Physical Activity as assessed by the Rapid Assessment of Physical Activity RAPA Part 1 score | 5.0 Survey score STANDARD_DEVIATION 1 | 5.0 Survey score STANDARD_DEVIATION 1 | 5.0 Survey score STANDARD_DEVIATION 1 |
| Physical Activity as assessed by the Rapid Assessment of Physical Activity RAPA Part 2 score | 1.6 Survey score STANDARD_DEVIATION 2.6 | 1.0 Survey score STANDARD_DEVIATION 2 | 2.0 Survey score STANDARD_DEVIATION 3 |
| Quality of life as assessed by the Atrial Fibrillation Effect on Quality-of-Life | 75.6 Survey score STANDARD_DEVIATION 28 | 78.7 Survey score STANDARD_DEVIATION 24.1 | 73.1 Survey score STANDARD_DEVIATION 31.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 26 Participants | 28 Participants |
| Sex: Female, Male Female | 23 Participants | 10 Participants | 13 Participants |
| Sex: Female, Male Male | 37 Participants | 20 Participants | 17 Participants |
| Skills in applying electronic health information to health problems | 39.3 Survey score STANDARD_DEVIATION 4.9 | 38.2 Survey score STANDARD_DEVIATION 4.8 | 40.2 Survey score STANDARD_DEVIATION 4.9 |
| Stress level as assessed by the Perceived Stress Score | 10.0 Survey score STANDARD_DEVIATION 9.5 | 10.1 Survey score STANDARD_DEVIATION 5.1 | 10.0 Survey score STANDARD_DEVIATION 13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 4 / 30 | 5 / 31 |
| serious Total, serious adverse events | 1 / 30 | 0 / 31 |
Outcome results
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)
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Number of Participants Who Continue Study Participation at 12 Weeks | 26 Participants |
| Usual Care | Number of Participants Who Continue Study Participation at 12 Weeks | 29 Participants |
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.
Time frame: 12 weeks
Population: Some participants chose not to complete this survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test | 2.0 score on a scale | Standard Deviation 2 |
| Usual Care | Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test | 2.0 score on a scale | Standard Deviation 3 |
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.
Time frame: 12 weeks
Population: Some participants chose not to complete this survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score | 1.0 score on a scale | Standard Deviation 2 |
| Usual Care | Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score | 1.0 score on a scale | Standard Deviation 3 |
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.
Time frame: 12 weeks
Population: Some participants chose not to complete this survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | AF duration score | 3.1 score on a scale | Standard Deviation 2.4 |
| Corrie Virtual Atrial Fibrillation Management Program | Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | AF frequency score | 3.6 score on a scale | Standard Deviation 2.5 |
| Corrie Virtual Atrial Fibrillation Management Program | Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | AF severity score | 4.6 score on a scale | Standard Deviation 2.8 |
| Corrie Virtual Atrial Fibrillation Management Program | Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | AF symptoms score | 3.0 score on a scale | Standard Deviation 4 |
| Corrie Virtual Atrial Fibrillation Management Program | Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | AF burden score (sum of duration, severity, and frequency subscores) | 11.3 score on a scale | Standard Deviation 4.5 |
| Usual Care | Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | AF symptoms score | 7.6 score on a scale | Standard Deviation 7.8 |
| Usual Care | Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | AF burden score (sum of duration, severity, and frequency subscores) | 12.7 score on a scale | Standard Deviation 5 |
| Usual Care | Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | AF duration score | 4.3 score on a scale | Standard Deviation 2.7 |
| Usual Care | Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | AF severity score | 5.4 score on a scale | Standard Deviation 2.6 |
| Usual Care | Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale | AF frequency score | 3.0 score on a scale | Standard Deviation 1.7 |
Secondary
Blood Pressure
Measured in millimeters of mercury (mmHg).
Time frame: 12 weeks
Population: Some participants did not complete the 12-week follow-up visit where blood pressure was assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Blood Pressure | Systolic blood pressure | 123.1 mmHg | Standard Deviation 16.3 |
| Corrie Virtual Atrial Fibrillation Management Program | Blood Pressure | Diastolic blood pressure | 75.6 mmHg | Standard Deviation 8.7 |
| Usual Care | Blood Pressure | Systolic blood pressure | 123.3 mmHg | Standard Deviation 14.2 |
| Usual Care | Blood Pressure | Diastolic blood pressure | 73.4 mmHg | Standard Deviation 9.9 |
Secondary
Body Mass Index (BMI)
Measured in kilograms over meter squared (Kg/m\^2).
Time frame: 12 weeks
Population: Not all participants completed the 12-week follow-up visit where weight was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Body Mass Index (BMI) | 29.6 kg/m^2 | Standard Deviation 4.8 |
| Usual Care | Body Mass Index (BMI) | 29.9 kg/m^2 | Standard Deviation 7 |
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.
Time frame: 12 weeks
Population: Some participants chose not to complete this survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Depressive Symptoms as Assessed by the Patient Health Questionnaire 8 | 1.0 Survey score | Standard Deviation 4 |
| Usual Care | Depressive Symptoms as Assessed by the Patient Health Questionnaire 8 | 3.0 Survey score | Standard Deviation 3 |
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.
Time frame: 12 weeks
Population: Some participants chose not to complete this survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Diet as Assessed by the Rate Your Plate (RYP) Scale | 65.1 Survey score | Standard Deviation 5.3 |
| Usual Care | Diet as Assessed by the Rate Your Plate (RYP) Scale | 64.0 Survey score | Standard Deviation 6.2 |
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.
Time frame: 12 weeks
Population: Some participants chose not to complete this survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Physical Activity as Assessed by the Rapid Assessment of Physical Activity | RAPA Part 1 score | 5.0 Survey score | Standard Deviation 0.5 |
| Corrie Virtual Atrial Fibrillation Management Program | Physical Activity as Assessed by the Rapid Assessment of Physical Activity | RAPA Part 2 score | 1.0 Survey score | Standard Deviation 2 |
| Usual Care | Physical Activity as Assessed by the Rapid Assessment of Physical Activity | RAPA Part 1 score | 5.0 Survey score | Standard Deviation 1 |
| Usual Care | Physical Activity as Assessed by the Rapid Assessment of Physical Activity | RAPA Part 2 score | 2.0 Survey score | Standard Deviation 3 |
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.
Time frame: 12 weeks
Population: Some participants chose not to complete this survey.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life | 87.0 score on a scale | Standard Deviation 24.1 |
| Usual Care | Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life | 76.0 score on a scale | Standard Deviation 31.5 |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Satisfaction With Intervention | 78.25 score on a scale |
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.
Time frame: 12 weeks
Population: Some participants chose not to complete this survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Skills in Applying Electronic Health Information to Health Problems | 40.0 score on a scale | Standard Deviation 4 |
| Usual Care | Skills in Applying Electronic Health Information to Health Problems | 40.1 score on a scale | Standard Deviation 5.6 |
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.
Time frame: 12 weeks
Population: Some participants chose not to complete this survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Stress Level as Assessed by the Perceived Stress Score | 10.1 score on a scale | Standard Deviation 5.1 |
| Usual Care | Stress Level as Assessed by the Perceived Stress Score | 11.5 score on a scale | Standard Deviation 8.1 |
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.
Time frame: Studies were completed one time between enrollment and end of treatment at 12 weeks
Population: The control group did not complete a sleep study. Not all members of the intervention group chose to complete the sleep study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | At-home Sleep Study Results | Diagnosed with mild sleep apnea | 4 Participants |
| Corrie Virtual Atrial Fibrillation Management Program | At-home Sleep Study Results | Diagnosed with moderate to severe sleep apnea | 8 Participants |
| Corrie Virtual Atrial Fibrillation Management Program | At-home Sleep Study Results | Not diagnosed with sleep apnea | 14 Participants |
| Usual Care | At-home Sleep Study Results | Diagnosed with mild sleep apnea | 0 Participants |
| Usual Care | At-home Sleep Study Results | Diagnosed with moderate to severe sleep apnea | 0 Participants |
| Usual Care | At-home Sleep Study Results | Not diagnosed with sleep apnea | 0 Participants |