Trial Outcomes & Findings for Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke (NCT NCT03761394)
NCT ID: NCT03761394
Last Updated: 2023-11-18
Results Overview
System usability scale, self-reported, of likes, dislikes, and problems encountered with the smartphone application and smartwatch. Each item regarding likes and dislikes will be scored 1-5 (1= strongly disagree; 5= strongly agree or Didn't use). Problem encountered will be scored with yes or no options with space provided for explanations. Also, using Mobile Application Rating Scale (MARS) App Classification questions will capture the participants' experience with the application. Each MARS item uses a 5-point scale (1=inadequate, 2=poor, 3=acceptable, 4=Good, 5=Excellent) and sub-scales will have an average mean to indicate the overall rating of the application. Number of participants with SUS \> 68 was reported in the Outcome Measure Data Table
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Assessed 14 days post the first randomization
Results posted on
2023-11-18
Participant Flow
The study recruitment period was from September 2019 to September 2021. Participants were recruited from neurology and cardiology clinics at UMass Memorial and the Ambulatory Care Center, respectively. After participants were agreeable to joining the study, we gave them an IRB-stamped consent form that detailed the study's protocol. All study staff members were trained properly and had a complete understanding of study-related documentation to help answer any questions participants may have.
Patients were either randomized into the intervention or control arm of the study. The control patients were given a gold-standard cardiac monitor patch (2 patches over 14 days) but were not offered the use of the Pulsewatch system. Thereafter, we re-randomized the 120 participants into a 1:1 randomization of control group (n=60) and intervention group (n=60) to continue using the device for an additional 30 days. Control group did not receive any devices during this time.
Participant milestones
| Measure |
Intervention Group
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
14-day Intervention & Control Period
STARTED
|
90
|
30
|
0
|
0
|
|
14-day Intervention & Control Period
COMPLETED
|
87
|
28
|
0
|
0
|
|
14-day Intervention & Control Period
NOT COMPLETED
|
3
|
2
|
0
|
0
|
|
30-day Period (Extension 44 Days)
STARTED
|
0
|
0
|
57
|
58
|
|
30-day Period (Extension 44 Days)
COMPLETED
|
0
|
0
|
55
|
55
|
|
30-day Period (Extension 44 Days)
NOT COMPLETED
|
0
|
0
|
2
|
3
|
Reasons for withdrawal
| Measure |
Intervention Group
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
14-day Intervention & Control Period
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
14-day Intervention & Control Period
Withdrawal by Subject
|
3
|
1
|
0
|
0
|
|
30-day Period (Extension 44 Days)
Lost to Follow-up
|
0
|
0
|
2
|
0
|
|
30-day Period (Extension 44 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
Baseline characteristics by cohort
| Measure |
Intervention Group
n=89 Participants
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
n=30 Participants
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
No device usage for 30-days following completion of the original 14-day period.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
—
|
—
|
46 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
—
|
—
|
73 Participants
n=21 Participants
|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 8.68 • n=7 Participants
|
—
|
—
|
67.9 years
STANDARD_DEVIATION 9.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
—
|
—
|
50 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
—
|
—
|
69 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
—
|
—
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
—
|
—
|
99 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
—
|
—
|
103 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=5 Participants
|
30 participants
n=7 Participants
|
—
|
—
|
119 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Assessed 14 days post the first randomizationPopulation: Only the intervention group in the first phase had outcomes assessed for their Pulsewatch system usability. The overall number analyzed is 83 instead of 90 because 3 participants withdrew and the other 4 participants either had their device lost in transit or the data was not able to sync.
System usability scale, self-reported, of likes, dislikes, and problems encountered with the smartphone application and smartwatch. Each item regarding likes and dislikes will be scored 1-5 (1= strongly disagree; 5= strongly agree or Didn't use). Problem encountered will be scored with yes or no options with space provided for explanations. Also, using Mobile Application Rating Scale (MARS) App Classification questions will capture the participants' experience with the application. Each MARS item uses a 5-point scale (1=inadequate, 2=poor, 3=acceptable, 4=Good, 5=Excellent) and sub-scales will have an average mean to indicate the overall rating of the application. Number of participants with SUS \> 68 was reported in the Outcome Measure Data Table
Outcome measures
| Measure |
Intervention Group
n=83 Participants
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
Usability of Pulsewatch System (System Usability Scale & Rating Scale) at 14 Days Post the First Randomization
|
31 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed throughout 14 day trial periodPopulation: Control, Intervention Group for Extended Use, and Control Group for Extended Use Groups analyses are not applicable. The number of participants analyzed is 89 because one participant's device was lost in transit so we were unable to get the device to extract the data.
This outcome was measured by the number of atrial fibrillation episodes identified by the smartwatch biosensors. This was conducted using two approaches. Firstly, the Pulsewatch app sent a message to participants to remain still and perform a 30-sec ECG self-check (wrist electrode, high accuracy) should they have an AF episode detected. The second approach involved the cancellation of cyclical frequencies, seen in accelerometer data, from the photoplethysmogram (PPG) signal. Thus, these two approaches were effectively used to recover some data segments contaminated by MNA or by poor signal quality and correctly identified the presence or absence of AF. Once MN artifacts were corrected, we looked at patterns to analyze pulse waveforms for AF detection, including discrimination of PVCs and PACs
Outcome measures
| Measure |
Intervention Group
n=89 Participants
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
The Number of Participants With Atrial Fibrillation Detected by Smartwatch at the 14 Day Trial Period
|
7 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed at 14 days post the first randomization.Population: Intervention Group for Extended Use and Control Group for Extended Use analyses are not applicable. One participant did not activate their Cardea solo device and one participant could discontinued wearing the device due to allergic reaction.
Episodes of atrial fibrillation was identified by the gold-standard monitor (Cardea Solo by Cardiac Insight). The Cardiac Insight patches have a module chip inside the sensor that stores the data being collected over the 14-days. After the participants returned the patches at the end of the 14-day monitoring period, a trained study staff removed the modules and placed them into the Cardiac insight smart cable to be uploaded to a UMass Medical School server. The ECG readings are then read by a board-certified cardiologist to confirm true atrial fibrillation detection.
Outcome measures
| Measure |
Intervention Group
n=88 Participants
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
n=29 Participants
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
The Number of Participants With Detection of Atrial Fibrillation by a Patch Monitor (Confirmed by Cardiologist Overread) at 14 Days Post the First Randomization.
|
6 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)Anxiety will be assessed using the Generalized Anxiety Disorder-7 scale (GAD-7), a revised version of the anxiety module from the Patient Health Questionnaire, which consists of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for generalized anxiety disorder over the past 2 weeks. The GAD-7 score ranges from 0-27 with scores of 5, 10 and 15 representing validated cut-points for mild, moderate and severe levels of anxiety symptoms, with a score ≥10 having high sensitivity (0.89) and specificity (0.82) for psychiatrist diagnosed anxiety disorder and correlates significantly with health-related QoL. This change in outcome was between baseline and the last study visit 30 days post the second randomization.
Outcome measures
| Measure |
Intervention Group
n=41 Participants
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
n=13 Participants
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
n=41 Participants
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
n=13 Participants
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
Change in Anxiety Symptoms at Baseline and at the Last Study Visit 30 Days Post the Second Randomization.
|
0.17 score on a scale
Standard Deviation 3.61
|
-0.77 score on a scale
Standard Deviation 2.39
|
0.56 score on a scale
Standard Deviation 3.44
|
-0.46 score on a scale
Standard Deviation 3.69
|
SECONDARY outcome
Timeframe: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)The Short Form (SF-12) health survey to assess health related quality of life, this validated instrument domains include general health questions and mental health related questions. Scores range from 0 to 100, where higher scores indicate higher level of health. This change in outcome was between baseline and the last study visit 30 days post the second randomization (44 days).
Outcome measures
| Measure |
Intervention Group
n=41 Participants
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
n=14 Participants
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
n=41 Participants
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
n=13 Participants
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
Change in General Health MCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
|
1.56 score on a scale
Standard Deviation 6.79
|
3.10 score on a scale
Standard Deviation 6.29
|
2.90 score on a scale
Standard Deviation 7.51
|
1.08 score on a scale
Standard Deviation 6.38
|
SECONDARY outcome
Timeframe: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)Population: The outcome measure timeframe is at baseline and at the last study visit 30 days post the second randomization (44 days) for both control and intervention groups.
The Short Form (SF-12) health survey to assess health related quality of life, this validated instrument domains include general health questions and physical health-related questions. Scores range from 0 to 100, where higher scores indicate a higher level of health. This outcome was assessed at baseline and at the last study visit 30 days post the second randomization (44 days).
Outcome measures
| Measure |
Intervention Group
n=41 Participants
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
n=14 Participants
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
n=41 Participants
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
n=13 Participants
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
Change in General Health PCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
|
0.35 score on a scale
Standard Deviation 6.86
|
0.27 score on a scale
Standard Deviation 3.42
|
-0.04 score on a scale
Standard Deviation 6.03
|
0.36 score on a scale
Standard Deviation 4.60
|
SECONDARY outcome
Timeframe: Assessed at baseline and 14 days post the first randomizationPopulation: The outcome measure timeframe is at baseline and 14 days post-randomization. Intervention Group for Extended Use and Control Group for Extended Use are not applicable to this analysis
Self-efficacy for disease management is associated with engagement in health behaviors and with improved medication adherence. The General Disease Management scale is a 5-item scale assessing confidence in disease self-management (scores 0-50, higher scores = greater confidence, lower scores = lower confidence). This change in outcome was between baseline and 14 days post the first randomization.
Outcome measures
| Measure |
Intervention Group
n=82 Participants
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
n=27 Participants
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
Change in Disease Management Self-Efficacy (The General Disease Management Scale) at Baseline and 14 Days Post the First Randomization
|
0.67 score on a scale
Standard Deviation 5.76
|
-9.03 score on a scale
Standard Deviation 4.79
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at baseline and 14 days post randomizationPopulation: The outcome measure timeframe is at baseline and 14 days post-randomization. Intervention Group for Extended Use and Control Group for Extended Use are not applicable to this analysis
Self-efficacy for disease management is associated with engagement in health behaviors and with improved medication adherence. The Symptom Management scale is a 5-item scale assessing confidence in managing chronic disease symptoms (items tailored to the sample), with scores ranging from 0 to 100. A higher symptom management score indicates a higher confidence in managing symptoms. Conversely, a lower score indicates a lower confidence in managing symptoms. This change in outcome was between baseline and 14 days post randomization.
Outcome measures
| Measure |
Intervention Group
n=82 Participants
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
n=27 Participants
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
Change in Symptom Management Self-Efficacy at Baseline and 14 Days Post Randomization
|
1.52 score on a scale
Standard Deviation 8.81
|
0.74 score on a scale
Standard Deviation 4.61
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)Patient activation refers to a patient's ability and willingness to manage their health. Activation will be measured using the 10-item Consumer Health Activation Index (CHAI). Scores range from 10 to 60. A higher score indicates that the patient has higher activation for self-management of their condition. Conversely, a lower score indicates lower activation for self-management of their condition. This change in outcome was between the baseline and the last study visit 30 days post the second randomization (44 days)
Outcome measures
| Measure |
Intervention Group
n=40 Participants
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
n=14 Participants
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
n=41 Participants
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
n=13 Participants
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
Change in Patient Activation Score at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
|
3.75 score on a scale
Standard Deviation 15.35
|
2.00 score on a scale
Standard Deviation 5.71
|
4.29 score on a scale
Standard Deviation 10.57
|
1.54 score on a scale
Standard Deviation 6.98
|
SECONDARY outcome
Timeframe: Assessed at baseline and 14 days post the first randomizationPopulation: Only the intervention group has analyzable data for this outcome. Control Group, Intervention Group for Extended Use, and Control Group for Extended Use are not applicable to this analysis. The number of participants analyzed was 76 because participants either withdrew, were lost to follow-up, or skipped these questions on the questionnaire.
Medication adherence will be measured using the 12-item Adherence to Refills and Medications Scale (ARMS), a well-validated measure of patient-reported adherence. The minimum to maximum ARMS score ranges from 1 to 4. Higher scores indicate poorer adherence, and lower scores indicate better medication adherence. This change in outcome was between baseline and 14 days post the first randomization.
Outcome measures
| Measure |
Intervention Group
n=76 Participants
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
Change in Medication Adherence at Baseline and 14 Days Post the First Randomization
|
-1.12 score on a scale
Standard Deviation 2.50
|
—
|
—
|
—
|
Adverse Events
Intervention Group
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Group
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Intervention Group for Extended Use
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group for Extended Use
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Group
n=90 participants at risk
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
n=30 participants at risk
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
n=57 participants at risk
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
n=58 participants at risk
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction and hospitalization
|
0.00%
0/90 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
3.3%
1/30 • Number of events 1 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
0.00%
0/57 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
0.00%
0/58 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
|
Infections and infestations
COVID-19
|
0.00%
0/90 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
3.3%
1/30 • Number of events 1 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
0.00%
0/57 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
0.00%
0/58 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
|
Cardiac disorders
Chest Pain and hospitalization
|
1.1%
1/90 • Number of events 1 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
0.00%
0/30 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
0.00%
0/57 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
0.00%
0/58 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
|
Infections and infestations
Pancreatitis
|
0.00%
0/90 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
3.3%
1/30 • Number of events 1 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
1.8%
1/57 • Number of events 1 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
0.00%
0/58 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
Other adverse events
| Measure |
Intervention Group
n=90 participants at risk
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Control Group
n=30 participants at risk
Only Cardea Solo device by Cardiac Insight for 14-day period.
Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices.
|
Intervention Group for Extended Use
n=57 participants at risk
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Testing Devices: Pulsewatch system testing application on smartphone with smartwatch.
Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period.
|
Control Group for Extended Use
n=58 participants at risk
No device usage for 30-days following completion of the original 14-day period.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.1%
1/90 • Number of events 1 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
10.0%
3/30 • Number of events 3 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
0.00%
0/57 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
0.00%
0/58 • The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place