Trial Outcomes & Findings for iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology (NCT NCT02731326)

Last Updated: 2024-07-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

264 participants

Primary outcome timeframe

Six months

Results posted on

2024-07-03

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	Usual Care Participants will continue with usual care with their physician.
Overall Study STARTED	131	131
Overall Study COMPLETED	115	123
Overall Study NOT COMPLETED	16	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Usual Care Participants will continue with usual care with their physician.
Overall Study Withdrawal by Subject	4	1
Overall Study No Cardioversion or Ablation Procedure	1	6
Overall Study Discharged without AliveCor	10	0
Overall Study Duplicate Participant	1	1

Baseline Characteristics

iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iHEART n=115 Participants 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.	Usual Care n=123 Participants Participants will continue with usual care with their physician.	Total n=238 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 12 • n=5 Participants	61 years STANDARD_DEVIATION 12 • n=7 Participants	61 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	96 Participants n=7 Participants	184 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	17 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=5 Participants	67 Participants n=7 Participants	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	44 Participants n=5 Participants	39 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants	93 Participants n=7 Participants	181 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	115 participants n=5 Participants	123 participants n=7 Participants	238 participants n=5 Participants
Procedure at Enrollment: Radiofrequency Ablation	60 Participants n=5 Participants	43 Participants n=7 Participants	103 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	iHEART n=115 Participants 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.	Usual Care n=118 Participants Participants will continue with usual care with their physician.
Rate of Recurrence of Atrial Arrhythmias	0.132 episodes per person-month of follow-up Standard Deviation 0.014	0.091 episodes per person-month of follow-up Standard Deviation 0.012

PRIMARY outcome

Timeframe: 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.

Time to treatment for recurrence of atrial arrhythmia from detection of arrhythmia to 6 months

Outcome measures

Outcome measures
Measure	iHEART n=58 Participants 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.	Usual Care n=49 Participants Participants will continue with usual care with their physician.
Time to Treatment for Recurrence of Atrial Arrhythmia	43 days Standard Deviation 41	33 days Standard Deviation 36

PRIMARY outcome

Timeframe: 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.

Number of intervention and control group patients with recurrent atrial arrhythmia who received treatment for recurrent atrial arrhythmia

Outcome measures

Outcome measures
Measure	iHEART n=58 Participants 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.	Usual Care n=49 Participants Participants will continue with usual care with their physician.
Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia	21 Participants	35 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	iHEART n=58 Participants 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.	Usual Care n=56 Participants Participants will continue with usual care with their physician.
Difference in Quality-Adjusted Life Years (QALYS) Between Intervention and Control Groups	0.94 score on a scale Standard Deviation 0.14	0.91 score on a scale Standard Deviation 0.13

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	iHEART n=44 Participants 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.	Usual Care n=23 Participants Participants will continue with usual care with their physician.
Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores Between Baseline and Six Months	0.27 score on a scale Standard Deviation 2.08	.17 score on a scale Standard Deviation 2.93

Adverse Events

iHEART

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Suzanne Bakken, PhD, RN

Columbia University

Phone: 212-305-1278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place