Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-28 @ 11:17 AM
Study NCT ID:
NCT05344950
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Connecting Audio and Radio Sensing Systems to Improve Care at Home
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Development and Pilot Testing of AURA
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AURA
Brief Summary:
This study aims to assess the usability of the innovative Audio + Radio (AURA) system in enhancing personalized supportive care for cancer patients and caregivers during the post-ostomy care transition by collecting information on patient's daily activities and answers to survey questionnaire, and enabling access to this information through a voice assistant device.
Detailed Description:
The investigators will assign up to 30 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the AURA or usual care groups (up to 30 patient-caregiver dyads, a total of 60 individuals). AURA is defined as a system that connects audio-based voice assistant devices with radiofrequency (RF) sensing technology to gather relevant patient information automatically, interactively, and with context-awareness and to store a patient's health records that otherwise had to be measured and entered manually into an electronic system. Additionally, the system enables user's access to this information through a voice assistant device. The users of this system will be the entire care team, consisting of the patient and their family members as well as the caregivers and healthcare providers at remote sites. If results indicate that the pilot trial is feasible, the investigators will design and conduct a definitive trial to examine the efficacy of AURA, a potentially scalable intervention that can be disseminated through oncology clinics nationwide to enhance post-treatment care for cancer patients with ostomies who transition from hospital professional care to self-management at home and their caregivers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: