Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159127
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-11-28
Brief Title:
SMARTHome Feasibility Trial
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Self-Management Assistance for Recommended Treatment SMARTHome Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients Previous attempts have had poor clinical validity and suffered lack of patient engagement The study team will deconstruct the previously implemented SMART platforms to create a roadmap platform and template to guide clinicians to create new tools
Results from Phase 1 of this project highlighted the need for connectivity between the SMARTHome app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making A subsequent pilot user validation trial is also needed to confirm development goals were met Conducting a pilot user validation trial of the SMARTHome asthma tracker spirometer and action plan is the purpose of the next phases of this study
Results from Phase 1 of this project highlighted the need for connectivity between the SMARTHome app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making A subsequent pilot user validation trial is also needed to confirm development goals were met Conducting a pilot user validation trial of the SMARTHome asthma tracker spirometer and action plan is the purpose of the next phases of this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None