Proactive Monitoring: Managing Participant Compliance & Data Quality
A guide for Site Staff to monitor participant adherence, troubleshoot remote data synchronization issues, and maintain high signal quality throughout the study.
Verifying Data Synchronization in OneView
One of the most critical "lessons learned" in remote monitoring is differentiating between a participant who is not wearing the Recorder and a participant whose data is simply not synchronizing You must check the OneView Dashboard regularly to ensure data is flowing from the participant's device to the server.
Interpreting Sync Statuses
When viewing a Subject's profile in OneView, check the status of their recordings:
- Created/Processing: The data has been transferred from the Recorder to the smartphone via Bluetooth but has not yet fully uploaded to the server.
- Uploaded/Completed: The data has successfully reached the Hexoskin server and is safe.
- Sync Failed: The transfer was interrupted.
Note: The "Processing" Lag
If a participant sees "Processing" or "Created" in their app for a long time, it usually means the phone is not close enough to the Recorder during charging, or the internet connection is unstable. Instruct the participant to keep the Hexoskin App open and the phone near the Recorder while it charges to allow the sync to complete.
Troubleshooting Signal Quality Remotely
If you observe gaps in the data or poor ECG signals in the OneView dashboard, it is often due to fit or preparation issues rather than Recorder failure.
Common Causes for Data Quality Issues
If the participant reports a Yellow Light on their recorder, or if you see artifacts in the data, verify the following checklist with the participant:
- Cream Application: Did they apply the conductive cream to all four sensors?
- Undergarments: Is the participant wearing a bra under the shirt? This blocks the sensors. Bras must be worn overthe shirt.
- High-Waisted Clothing: Are high-waisted pants tucked under the shirt? If they are worn under the shirt, they can block the abdominal sensors. We recommend tucking the shirt into the pants.
[Image: Diagram comparing correct shirt fit vs incorrect fit with high-waisted pants]
Managing Long-Term Adherence & Fit Changes
For protocols involving long-term monitoring, participants' body metrics may change, affecting the quality of the data collected by the sensors.
Adjusting for Weight Loss
If a participant loses weight during the study, the shirt may become too loose, resulting in poor sensor contact and unusable data.
- Step 1: Instruct the participant to tighten the elastic straps, located at the thorax and navel.
- Step 2: If the shirt is still loose after adjustment, you must assign a new shirt size. Contact trial@hexoskin.comimmediately to request a smaller size.
Note: Sizing Priority
Always prioritize a snug fit. If a participant is between sizes, choose the smaller size, as the fabric stretches up to 2 inches.
Using OneSync for Data Recovery
If a participant consistently fails to sync data via the mobile app (e.g., due to poor home Wi-Fi), do not let data be lost.
- Action: Retrieve the Recorder from the participant physically.
- Procedure: Connect their Recorder to the site computer using the USB cable and launch Hexoskin OneSync. This bypasses the mobile app and uploads data directly to the server.
[Image: Screenshot of OneSync desktop application interface showing a connected device]
If you are unable to use OneSync for Data Recovery, assign a new Recorder to the participant and contact trial@hexoskin.com for further assistance.