Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT04086251
Brief Summary:
The goal of this research is to study an intervention, which the investigators call "Remote Electronic Patient Monitoring," that entails vital sign data (enabled with smart algorithms for notification) and patient-reported outcomes (PROs), (such as physical and psychological symptoms) intended to address and manage any concerning issues and or diagnoses identified.
Specifically, the plan is a study of oncology patients who will use the Gaido system for up to 21 days or per physician order.
Detailed Description:
Gaido Health's Remote Patient Monitoring Solution v1.0 is a wireless remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Every 15 minutes, a measurement is plotted on the User Interface of heart rate / respiration rate (by a Biovotion device). A non-invasive blood pressure (by an Omron device) along with an oral digital thermometer reading are taken per clinician orders and displayed on the Gaido dashboard. Wearable data are transmitted wirelessly from the Biovotion sensor (heart rate and respiratory rate) to the patient's smart phone that relays data to a cloud-based server for storage and analysis. Oral temperature and blood pressure are entered by the patient or care-giver into the patient's smart phone that relays data to a cloud-based server for storage.
The Remote Patient Monitoring system uses algorithms that indicate when patient vitals and patient reported outcomes have changed. Automatic patient surveys are sent to the patient with results displayed both on the computer located in the medical institution and the patient's smart phone. The patient surveys gather patient reported symptoms which are intended to be used in combination with vital signs to support decision-making. The system is intended for use with patients 18 years of age and older who are cared for by healthcare professionals.
Study:
NCT04086251
Study Brief:
Protocol Section:
NCT04086251