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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iHEART | Experimental | 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. |
|
| Usual Care | No Intervention | Participants will continue with usual care with their physician. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AliveCor | Device | 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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months |
| Time to Treatment for Recurrence of Atrial Arrhythmia | Time to treatment for recurrence of atrial arrhythmia from detection of arrhythmia to 6 months | Six months |
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Bakken, PhD, RN | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29135066 | Background | Hickey KT. Developing and Sustaining a Career as a Transdisciplinary Nurse Scientist. J Nurs Scholarsh. 2018 Jan;50(1):20-27. doi: 10.1111/jnu.12359. Epub 2017 Nov 14. | |
| 27422639 | Background | Hickey KT, Hauser NR, Valente LE, Riga TC, Frulla AP, Masterson Creber R, Whang W, Garan H, Jia H, Sciacca RR, Wang DY. A single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol. BMC Cardiovasc Disord. 2016 Jul 16;16:152. doi: 10.1186/s12872-016-0327-y. |
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Research data will be disseminated for the whole study sample and not individually.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Participants will continue with usual care with their physician. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | 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. | Posted | Mean | Standard Deviation | episodes per person-month of follow-up | Six months |
|
6 months post enrollment procedure
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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 | 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. |
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While there was primary outcome data for all participants with the exception of 5 in the control group, secondary outcome measures reflect less than half the participants in the intervention and control groups due to missing data. Thus, findings related to secondary outcome measures should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Bakken, PhD, RN | Columbia University | 212-305-1278 | sbh22@columbia.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 15, 2020 | Jun 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Behavioral Altering Messaging | Behavioral | 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 |
|
| Six Months |
| 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. | Six months |
| 29438185 | Background | Hickey KT, Riga TC, Mitha SA, Reading MJ. Detection and management of atrial fibrillation using remote monitoring. Nurse Pract. 2018 Mar 12;43(3):24-30. doi: 10.1097/01.NPR.0000530214.17031.45. |
| 32494426 | Background | Hickey KT, Wan E, Garan H, Biviano AB, Morrow JP, Sciacca RR, Reading M, Koleck TA, Caceres B, Zhang Y, Goldenthal I, Riga TC, Masterson Creber R. A Nurse-led Approach to Improving Cardiac Lifestyle Modification in an Atrial Fibrillation Population. J Innov Card Rhythm Manag. 2019 Sep 15;10(9):3826-3835. doi: 10.19102/icrm.2019.100902. eCollection 2019 Sep. |
| 30304745 | Result | Reading M, Baik D, Beauchemin M, Hickey KT, Merrill JA. Factors Influencing Sustained Engagement with ECG Self-Monitoring: Perspectives from Patients and Health Care Providers. Appl Clin Inform. 2018 Oct;9(4):772-781. doi: 10.1055/s-0038-1672138. Epub 2018 Oct 10. |
| 31507001 | Result | Goldenthal IL, Sciacca RR, Riga T, Bakken S, Baumeister M, Biviano AB, Dizon JM, Wang D, Wang KC, Whang W, Hickey KT, Garan H. Recurrent atrial fibrillation/flutter detection after ablation or cardioversion using the AliveCor KardiaMobile device: iHEART results. J Cardiovasc Electrophysiol. 2019 Nov;30(11):2220-2228. doi: 10.1111/jce.14160. Epub 2019 Sep 25. |
| 32675627 | Result | Koleck TA, Mitha SA, Biviano A, Caceres BA, Corwin EJ, Goldenthal I, Creber RM, Turchioe MR, Hickey KT, Bakken S. Exploring Depressive Symptoms and Anxiety Among Patients With Atrial Fibrillation and/or Flutter at the Time of Cardioversion or Ablation. J Cardiovasc Nurs. 2021 Sep-Oct 01;36(5):470-481. doi: 10.1097/JCN.0000000000000723. |
| 32015256 | Result | Caceres BA, Hickey KT, Bakken SB, Biviano AB, Garan H, Goldenthal IL, Koleck TA, Masterson-Creber R, Turchioe MR, Jia H. Mobile Electrocardiogram Monitoring and Health-Related Quality of Life in Patients With Atrial Fibrillation: Findings From the iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology (iHEART) Study. J Cardiovasc Nurs. 2020 Jul/Aug;35(4):327-336. doi: 10.1097/JCN.0000000000000646. |
| Discharged without AliveCor |
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| Duplicate Participant |
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| BG001 | Usual Care | Participants will continue with usual care with their physician. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number | participants |
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| Procedure at Enrollment: Radiofrequency Ablation | Count of Participants | Participants |
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| OG001 | Usual Care | Participants will continue with usual care with their physician. |
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| Primary | Time to Treatment for Recurrence of Atrial Arrhythmia | Time to treatment for recurrence of atrial arrhythmia from detection of arrhythmia to 6 months | 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. | Posted | Mean | Standard Deviation | days | Six months |
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| 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 | 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. | Posted | Count of Participants | Participants | 6 months |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Six Months |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Six months |
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|
| 0 |
| 131 |
| 0 |
| 131 |
| 0 |
| 131 |
| EG001 | Usual Care | Participants will continue with usual care with their physician. | 0 | 131 | 0 | 131 | 0 | 131 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |