Trial Outcomes & Findings for mHealth Screening to Prevent Strokes (NCT NCT02506244)
NCT ID: NCT02506244
Last Updated: 2022-12-08
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6135 participants
Primary outcome timeframe
End of 4 month monitoring period
Results posted on
2022-12-08
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
Match Controls
Observational matched controls that underwent routine care and were not given a Zio patch
|
|---|---|---|---|
|
Overall Study
STARTED
|
1366
|
1293
|
3476
|
|
Overall Study
COMPLETED
|
908
|
834
|
3476
|
|
Overall Study
NOT COMPLETED
|
458
|
459
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Match Controls
Observational matched controls that underwent routine care and were not given a Zio patch
|
|---|---|---|---|
|
Overall Study
Did not undergo active monitoring
|
458
|
459
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Immediate Monitoring
n=1366 Participants
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.
|
Delayed Monitoring
n=1293 Participants
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.
|
Matched Controls
n=3476 Participants
Individuals that underwent routine care and were not given a Zio XT patch sensor.
|
Total
n=6135 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.5 years
STANDARD_DEVIATION 7.4 • n=1366 Participants
|
73.1 years
STANDARD_DEVIATION 7.2 • n=1293 Participants
|
73.7 years
STANDARD_DEVIATION 7.0 • n=3476 Participants
|
73.7 years
STANDARD_DEVIATION 7.0 • n=6135 Participants
|
|
Sex: Female, Male
Female
|
521 Participants
n=1366 Participants
|
505 Participants
n=1293 Participants
|
1408 Participants
n=3476 Participants
|
2434 Participants
n=6135 Participants
|
|
Sex: Female, Male
Male
|
845 Participants
n=1366 Participants
|
788 Participants
n=1293 Participants
|
2068 Participants
n=3476 Participants
|
3701 Participants
n=6135 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1366 Participants
n=1366 Participants
|
1293 Participants
n=1293 Participants
|
3476 Participants
n=3476 Participants
|
6135 Participants
n=6135 Participants
|
PRIMARY outcome
Timeframe: End of 4 month monitoring periodPopulation: 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.
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)
Outcome measures
| Measure |
Delayed Monitoring
n=1293 Participants
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.
|
Immediate Monitoring
n=1366 Participants
Individuals randomized to immediate monitoring will receive patch in first 4 months
|
Matched Controls
Observational control cohort that was not given a Zio patch, but instead underwent routine care
|
|---|---|---|---|
|
Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group
|
12 Participants
|
53 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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
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.
Outcome measures
| Measure |
Delayed Monitoring
n=832 Participants
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.
|
Immediate Monitoring
n=906 Participants
Individuals randomized to immediate monitoring will receive patch in first 4 months
|
Matched Controls
n=3476 Participants
Observational control cohort that was not given a Zio patch, but instead underwent routine care
|
|---|---|---|---|
|
Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls
|
46 Participants
|
63 Participants
|
81 Participants
|
Adverse Events
Immediate Monitoring
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Delayed Monitoring
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Immediate Monitoring
n=908 participants at risk
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.
|
Delayed Monitoring
n=834 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation from Zio XT patch
|
2.2%
20/908 • Number of events 20 • 1 year
The only adverse events reported in this study were in relation to skin irritations developed from wearing the Zio patch. There was no risk of all-cause mortality or serious adverse events connected to wearing the patch so all-cause mortality and serious adverse events were not monitored/assessed The observational controls did not receive a patch and thus were not actively monitored for adverse events.
|
2.5%
21/834 • Number of events 21 • 1 year
The only adverse events reported in this study were in relation to skin irritations developed from wearing the Zio patch. There was no risk of all-cause mortality or serious adverse events connected to wearing the patch so all-cause mortality and serious adverse events were not monitored/assessed The observational controls did not receive a patch and thus were not actively monitored for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin irritation from Amigo wristband
|
0.00%
0/230 • 1 year
The only adverse events reported in this study were in relation to skin irritations developed from wearing the Zio patch. There was no risk of all-cause mortality or serious adverse events connected to wearing the patch so all-cause mortality and serious adverse events were not monitored/assessed The observational controls did not receive a patch and thus were not actively monitored for adverse events.
|
0.00%
0/230 • 1 year
The only adverse events reported in this study were in relation to skin irritations developed from wearing the Zio patch. There was no risk of all-cause mortality or serious adverse events connected to wearing the patch so all-cause mortality and serious adverse events were not monitored/assessed The observational controls did not receive a patch and thus were not actively monitored for adverse events.
|
Additional Information
Steven R. Steinhul, MD, Prinicipal Investigator
Scripps Research Translational Institute
Phone: 858-554-5757
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place