The ICF provides participants with essential information about the study, including its purpose, procedures, risks, benefits, privacy protections, and voluntary nature. It explains that the Hyfe CoughMonitor Suite detects coughs using short sound signatures without storing audio, ensuring privacy. The document outlines participant rights, data confidentiality, data storage practices, and conditions for withdrawal. A second section contains the formal consent certificate, with signature fields, witness options for illiterate participants, and a researcher attestation confirming proper explanation and voluntary participation.
This brochure introduces participants to the CoughMonitor Suite, including the watch, mobile Companion app, and device components. It provides instructions on wearing the watch daily, charging it nightly within 3 feet of the participant, checking data sync, and troubleshooting common issues such as reconnection steps when the watch appears disconnected. The brochure also explains environmental limitations (temperature, water exposure), how to return the device at study completion, and how to close the app when needed for troubleshooting.
The comprehensive Site Manual provides full operational details for research teams using the CoughMonitor Suite. It includes device specifications, safety and cleaning guidance, software update processes, and step-by-step procedures for enrollment, pairing, monitoring, troubleshooting, and ending sessions. It outlines participant instructions for both daytime and nighttime use, data synchronization workflows, and escalation steps for technical issues. The manual also includes processes for submitting Data Correction Forms and for returning equipment, serving as the primary reference for consistent study operations.
These visual mini-guides give site staff quick-reference instructions for starting, managing, and ending a cough monitoring session. They cover operating the CoughMonitor (battery, proximity, screen lock), enrolling participants through the dashboard, pairing the watch with the Companion app, and confirming data synchronization. Additional sections explain how to monitor syncing, respond to alerts when data has not synced for 36 hours, support participants with diary completion, and execute proper steps for session termination and device unpairing.