Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Wearable device, Wristband, ECG Patch, Strokes, Asymptomatic, Heart Rhythm, Home Monitoring
Brief summary
The purpose of this study is to investigate whether it is possible to identify a high-risk cohort suitable for screening for asymptomatic atrial fibrillation using claims data, and then engage those individuals in a mobile health technology-enabled home monitoring program in order to document previously undiagnosed atrial fibrillation, and provide clinical evidence of an outcomes benefit associated with this early detection.
Detailed description
The purpose of this study is to propose to study two different methods of intermittent rhythm monitoring in a cohort of individuals without prior history of atrial fibrillation, but determined to be at increased risk based on clinical risk factors, and compare the rate of atrial fibrillation detection through monitoring relative to routine care.
Interventions
DEVICEiRhythm ZIO XT Patch
Single-lead ECG monitoring via a wearable patch
DEVICEWristband by Amiigo
Determines pulse rate using photoplethysmography.
Sponsors
Janssen Scientific Affairs, LLC
Aetna, Inc.
Scripps Translational Science Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants: The study population will be derived from the Aetna and Medicare populations. Inclusion Criteria: * Male or females age \> 75 or * Male age \> 55, or females age \> 65, and * Prior CVA, or * Heart failure, or * Diagnosis of both diabetes and hypertension, or * Mitral valve disease, or * Left ventricular hypertrophy, or * COPD requiring home O2, or * Sleep apnea, or * History of pulmonary embolism, or * History of myocardial infarction, or * Diagnosis of obesity
Exclusion criteria
* Current or prior diagnosis of atrial fibrillation, atrial flutter or atrial tachycardia * Receiving chronic anticoagulation therapy * Hospice care * End stage renal disease * Diagnosis of moderate or greater dementia * Implantable pacemaker and/or defibrillator * History of skin allergies to adhesive patches * Known metastatic cancer * Aetna Compassionate Care Program (ACCP) participants - individuals with advanced illness and limited life expectancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group | End of 4 month monitoring period | Incidence of newly diagnosed AF as defined by at least 30 seconds of AF or atrial flutter at the end of the 4 month monitoring period compared to the delayed monitoring cohort (primary) and observational control (secondary) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls | 1 year | In the observational study, over 12 months of follow-up, we looked at the prevalence of AF in the actively monitored and delayed monitored cohorts. |
Countries
United States
Participant flow
Recruitment details
This was an observational study with two study arms, an immediate monitoring group and a delayed monitoring group. This was not a cross-over design study. The control group for this study consisted of participants that were not given the Zio patch. This group was used to compare who got routine care compared to the other arms that received the Zio patches.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Monitoring Individuals randomized to immediate monitoring will receive the ZIO XT patch sensor and wear it for the first and last 2 week period of the 4 month monitoring period of time 0 to 4 months.
Note: Approximately 250 consenting participants will also be invited to participate in a sub-study to wear an additional monitoring device (Amiigo wristband) continuously over the 4 month monitoring period.
iRhythm ZIO XT Patch: Single-lead ECG monitoring via a wearable patch
Wristband by Amiigo: Determines pulse rate using photoplethysmography. | 1,366 |
| Delayed Monitoring Individuals randomized to delayed monitoring will receive usual care for 4 months after which they will receive the ZIO XT patch sensor and wear it for the first and last 2 week period of study months 4 through 8.
Note: Approximately 250 consenting participants will also be invited to participate in a sub-study to wear an additional monitoring device (Amiigo wristband) daily for months 4 through 8.
iRhythm ZIO XT Patch: Single-lead ECG monitoring via a wearable patch
Wristband by Amiigo: Determines pulse rate using photoplethysmography. | 1,293 |
| Matched Controls Individuals that underwent routine care and were not given a Zio XT patch sensor. | 3,476 |
| Total | 6,135 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not undergo active monitoring | 458 | 459 | 0 |
Baseline characteristics
| Characteristic | Delayed Monitoring | Matched Controls | Total | Immediate Monitoring |
|---|---|---|---|---|
| Age, Continuous | 73.1 years STANDARD_DEVIATION 7.2 | 73.7 years STANDARD_DEVIATION 7 | 73.7 years STANDARD_DEVIATION 7 | 73.5 years STANDARD_DEVIATION 7.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 1293 Participants | 3476 Participants | 6135 Participants | 1366 Participants |
| Sex: Female, Male Female | 505 Participants | 1408 Participants | 2434 Participants | 521 Participants |
| Sex: Female, Male Male | 788 Participants | 2068 Participants | 3701 Participants | 845 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 20 / 908 | 21 / 834 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group
Incidence of newly diagnosed AF as defined by at least 30 seconds of AF or atrial flutter at the end of the 4 month monitoring period compared to the delayed monitoring cohort (primary) and observational control (secondary)
Time frame: End of 4 month monitoring period
Population: In the intention-to-treat analysis of the randomized clinical trial, we analyzed the incidence of new AF cases in the immediate monitoring group vs the delayed monitoring groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Monitoring | Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group | 53 Participants |
| Delayed Monitoring | Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group | 12 Participants |
Secondary
Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls
In the observational study, over 12 months of follow-up, we looked at the prevalence of AF in the actively monitored and delayed monitored cohorts.
Time frame: 1 year
Population: 906 participants that were in the immediate monitoring group had 12 months of follow-up data, 832 participants in the delayed monitoring group had 12 months of follow-up data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Monitoring | Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls | 63 Participants |
| Delayed Monitoring | Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls | 46 Participants |
| Matched Controls | Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls | 81 Participants |