Atrial Fibrillation, Atrial Flutter
Conditions
Brief summary
Atrial fibrillation (AF), a condition where the top chambers of the heart beat irregularly, is a major health problem. The long-term goal of this project is to use a personal, mobile heart monitor to help patients better recognize recurrent AF and improve patients' ability to better manage their condition. A total of 300 patients with a history of AF will be included in the study, with 150 patients receiving an iPhone with the mobile monitoring device and educational text messaging and the remaining 150 patients continuing with their regular medical care. Each patient will be included in the intervention period for 6 months. The rate of recurrent AF and treatments meant to manage AF and other heart conditions will be determined for both groups. Patients in both groups will complete a series of questionnaires at the start and end of the 6 month study period to look at differences in quality of life and knowledge of AF.
Detailed description
This study is a prospective randomized control trial with 1:1 randomization of 300 patients to either use the AliveCor device and receive behavioral altering motivational text messaging OR continue with usual care. The sample size and power was based on the test of the difference in AF detection rates between the intervention group and the control group in a similarly design pilot study. In the preliminary data there were 4 episodes of AF during the follow-up of 12 patients or a detection rate of 0.33 vs. a detection rate of 8% among controls. The detection window in this study as the time period from randomization to the 6-month follow-up will be defined. All patients' clinical records will be reviewed every month (via charts and/or internal and external electronic medical record systems) up until month 6 for initiations/changes in treatments targeting AF. A recurrence of AF in the chart and any related therapies that are initiated as a result of electrocardiogram (ECG) findings through usual cardiac care or from the AliveCor™ Heart Monitor will be specifically looked at. Changes in cardiovascular measures (blood pressure, glucose control, etc.) will be compared between groups. The effect of participating in the intervention, which includes targeted text messaging on AF knowledge and cardiovascular behavior change will be determined by comparing the change in AF knowledge scales from baseline to 6 months. This study will also measure and compare the incidence of documented AF in both groups, changes in prescribed treatment by healthcare providers over the 6-month period, and the relationship of the intervention to changes in cardiac measures and quality-adjusted life-years (QALYs) measured at baseline and 6 months. A biannual time period was chosen to capture AF redetection, changes in AF treatment, and self-reported quality of life based on other studies that have shown biannual time-points as most appropriate for collecting the proposed study endpoints.
Interventions
DEVICEAliveCor
The AliveCor Heart Monitor, an FDA-approved smartphone technology, snaps on to the patient's study smartphone similar to a protective case and works through a free application, AliveECG. It captures a highly sensitive (98%), specific (97%), and accurate (97%) single-lead ECG recording through two electrodes on the back of the patient's smartphone. When the application is opened, recording begins automatically when both electrodes make contact with skin. Transmissions are automatically uploaded to the study patient portal within the AliveCor cloud.
BEHAVIORALBehavioral Altering Messaging
Behavioral altering messages relating to the participant's AF and underlying cardiac risk factors will be systematically selected from a bank of text messages developed through collaboration by the study team and an expert interdisciplinary panel from the American Heart Association. The content of the text messages will not include PHI. The final text message bank will be housed internally and maintained by the Data Manager and text messages will be pushed automatically from this database. The only identifying link to participants included in this database will be their study-provided phone number
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females (English or Spanish speaking) age ≥ 18 years with a history of AF in the last 30 days that was treated with normal rhythm restored. * Ability to successfully use the AliveCor™ Heart Monitor, capture a baseline ECG, and transmit on the day of enrollment * Demonstrated ability to receive, read, and send a text messages on the day of enrollment * Willingness to complete the study questionnaires at baseline and 6 months
Exclusion criteria
* Documented permanent (chronic) AF * Patient found to be in AF or other rhythm disturbances on the day of enrollment (i.e., they need to be clinically evaluated or treated) * Unwillingness have their clinical data collected over the study period * Unwillingness to receive and read cardiovascular text messaging three times a week.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Recurrence of Atrial Arrhythmias | Six months | Examine the rate of recurrent atrial arrhythmias between the intervention and control group during the study period. The investigators will define and calculate recurrent AF detection rate as the ratio of the number of recurrent AF episodes to the number of person-months of follow-ups. |
| Time to Treatment for Recurrence of Atrial Arrhythmia | Six months | Time to treatment for recurrence of atrial arrhythmia from detection of arrhythmia to 6 months |
| Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia | 6 months | Number of intervention and control group patients with recurrent atrial arrhythmia who received treatment for recurrent atrial arrhythmia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Quality-Adjusted Life Years (QALYS) Between Intervention and Control Groups | Six Months | The EQ-5D index is a summary measure that assesses the value for preferring one health state to another. The full range of the EQ-5D index is 0 to 1. The EQ-5D index is anchored at 0 for death and 1 for full (optimal) health, so that having a reduced score of 0.5 is equivalent to living in full health only 50% of the time. Therefore, one year lived at a reduced EQ-5D index of 0.5 equals 0.5 QALYs which is the same as living a half year in full health. Higher scores mean a better outcome. QALYs were calculated from baseline to six months for patients whose EQ-5D index scores were available at both baseline and follow-up. |
| Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores Between Baseline and Six Months | Six months | Correlation between educational text messaging and participation in intervention on AF knowledge will be determined by comparing the change in mean scores between groups from the Atrial Fibrillation Knowledge Scale (AFKS) from baseline to 6 months. The AFKS is a valid instrument used to distinguish knowledge levels in AF patients. It is an 11-item scale including questions about AF in general, symptom recognition, and treatment and is validated (Cronbach α 0.58) to differentiate between knowledge changes in patients with AF. For each item patients can choose an answer out of three options, with one being the correct answer. The correct answer yields one point, while no points are added or subtracted to the score in case of an incorrect answer. The minimum score of the scale is 0 with a maximum score of 11. |
Countries
United States
Participant flow
Pre-assignment details
Two individuals that were enrolled failed to convert to normal sinus rhythm during direct current cardioversion (DCCV) so became ineligible for the study after enrollment and consent. Only 262 out of 264 participants had their data collected and analyzed.
Participants by arm
| Arm | Count |
|---|---|
| iHEART Participants will transmit daily ECGs using AliveCor for 6 months following cardioversion or ablation procedure to treat AF/AFL. Participants will also receive read-only behavioral altering messaging three times per week focusing on AF, cardiovascular risk factors, and healthy living.
AliveCor: The AliveCor Heart Monitor, an FDA-approved smartphone technology, works through a free application, AliveECG. It captures a highly sensitive (98%), specific (97%), and accurate (97%) single-lead ECG recording through two electrodes on the back of the patient's smartphone. When the application is opened, recording begins automatically when both electrodes make contact with skin. Transmissions are automatically uploaded to the study patient portal within the AliveCor cloud.
Behavioral Altering Messaging: Behavioral altering messages relating to the participant's AF and underlying cardiac risk factors will be sent three times per week. | 115 |
| Usual Care Participants will continue with usual care with their physician. | 123 |
| Total | 238 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discharged without AliveCor | 10 | 0 |
| Overall Study | Duplicate Participant | 1 | 1 |
| Overall Study | No Cardioversion or Ablation Procedure | 1 | 6 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | iHEART | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 12 | 61 years STANDARD_DEVIATION 12 | 61 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 17 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 67 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 44 Participants | 39 Participants | 83 Participants |
| Procedure at Enrollment: Radiofrequency Ablation | 60 Participants | 43 Participants | 103 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 11 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 | 23 Participants | 17 Participants | 40 Participants |
| Race (NIH/OMB) White | 88 Participants | 93 Participants | 181 Participants |
| Region of Enrollment United States | 115 participants | 123 participants | 238 participants |
| Sex: Female, Male Female | 88 Participants | 96 Participants | 184 Participants |
| Sex: Female, Male Male | 27 Participants | 27 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 131 | 0 / 131 |
| other Total, other adverse events | 0 / 131 | 0 / 131 |
| serious Total, serious adverse events | 0 / 131 | 0 / 131 |
Outcome results
Primary
Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia
Number of intervention and control group patients with recurrent atrial arrhythmia who received treatment for recurrent atrial arrhythmia
Time frame: 6 months
Population: The analysis population was the number of individuals who had recurrent atrial tachycardia detected in the intervention and control group. The analytic population only includes 58 out of 115 participants from the iHeart group and 49 out of 123 from the control group for whom we were unable to obtain follow-up data for this outcome variable.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iHEART | Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia | 21 Participants |
| Usual Care | Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia | 35 Participants |
p-value: <0.000195% CI: [0.19, 0.58]Regression, Cox
Primary
Rate of Recurrence of Atrial Arrhythmias
Examine the rate of recurrent atrial arrhythmias between the intervention and control group during the study period. The investigators will define and calculate recurrent AF detection rate as the ratio of the number of recurrent AF episodes to the number of person-months of follow-ups.
Time frame: Six months
Population: The analytic population excludes 5 individuals from the control group for whom we were unable to obtain follow-up data for this outcome variable. Data was collected and analyzed for 118 out of 123 participants in the Usual Care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iHEART | Rate of Recurrence of Atrial Arrhythmias | 0.132 episodes per person-month of follow-up | Standard Deviation 0.014 |
| Usual Care | Rate of Recurrence of Atrial Arrhythmias | 0.091 episodes per person-month of follow-up | Standard Deviation 0.012 |
Comparison: The study was designed to have 80% power to detect a hazard ratio of 2 for recurrence detection (α = .05). Kaplan-Meier curves were created for recurrence detection in the intervention and control groups over the 6-month follow-up period. Differences in time to recurrence between groups were assessed using a Cox proportional hazards model. Baseline variables that differed significantly between groups were included as covariates and adjusted Kaplan-Meier curves were constructed.p-value: 0.0595% CI: [1.06, 2.3]Regression, Cox
Primary
Time to Treatment for Recurrence of Atrial Arrhythmia
Time to treatment for recurrence of atrial arrhythmia from detection of arrhythmia to 6 months
Time frame: Six months
Population: The analytic population only includes 58 out of 115 participants from the iHeart group and 49 out of 123 from the control group for whom we were unable to obtain data for this outcome variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iHEART | Time to Treatment for Recurrence of Atrial Arrhythmia | 43 days | Standard Deviation 41 |
| Usual Care | Time to Treatment for Recurrence of Atrial Arrhythmia | 33 days | Standard Deviation 36 |
Comparison: Kaplan-Meier curves were created for assessing time to treatment for intervention and control groups. Time to treatment was defined as the time interval from detection of a recurrent arrhythmia to treatment for that arrhythmia.p-value: 0.0595% CI: [0.09, 0.58]Regression, Cox
Secondary
Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores Between Baseline and Six Months
Correlation between educational text messaging and participation in intervention on AF knowledge will be determined by comparing the change in mean scores between groups from the Atrial Fibrillation Knowledge Scale (AFKS) from baseline to 6 months. The AFKS is a valid instrument used to distinguish knowledge levels in AF patients. It is an 11-item scale including questions about AF in general, symptom recognition, and treatment and is validated (Cronbach α 0.58) to differentiate between knowledge changes in patients with AF. For each item patients can choose an answer out of three options, with one being the correct answer. The correct answer yields one point, while no points are added or subtracted to the score in case of an incorrect answer. The minimum score of the scale is 0 with a maximum score of 11.
Time frame: Six months
Population: The analysis population comprised the participants who had complete data on the AFKS score at baseline and 6 months. The analytic population only includes 44 out of 115 participants from the iHeart group and 23 out of 123 from the control group for whom we were unable to obtain follow-up data for this outcome variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iHEART | Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores Between Baseline and Six Months | 0.27 score on a scale | Standard Deviation 2.08 |
| Usual Care | Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores Between Baseline and Six Months | .17 score on a scale | Standard Deviation 2.93 |
p-value: 0.89t-test, 2 sided
Secondary
Difference in Quality-Adjusted Life Years (QALYS) Between Intervention and Control Groups
The EQ-5D index is a summary measure that assesses the value for preferring one health state to another. The full range of the EQ-5D index is 0 to 1. The EQ-5D index is anchored at 0 for death and 1 for full (optimal) health, so that having a reduced score of 0.5 is equivalent to living in full health only 50% of the time. Therefore, one year lived at a reduced EQ-5D index of 0.5 equals 0.5 QALYs which is the same as living a half year in full health. Higher scores mean a better outcome. QALYs were calculated from baseline to six months for patients whose EQ-5D index scores were available at both baseline and follow-up.
Time frame: Six Months
Population: The analysis population is the number of participants in the intervention and control group who had data on the EQ-5D at both baseline and follow-up which was required to calculate the QALYS. The analytic population only includes 58 out of 115 participants from the iHeart group and 56 out of 123 from the control group for whom we were unable to obtain follow-up data for this outcome variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iHEART | Difference in Quality-Adjusted Life Years (QALYS) Between Intervention and Control Groups | 0.94 score on a scale | Standard Deviation 0.14 |
| Usual Care | Difference in Quality-Adjusted Life Years (QALYS) Between Intervention and Control Groups | 0.91 score on a scale | Standard Deviation 0.13 |
p-value: 0.24t-test, 2 sided