Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04550052
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2020-08-27
Brief Title:
A-SPIRE Heart Failure Utilizing Health Tags to Identify Patients at Risk for Hospital Readmissions
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A-SPIRE Heart Failure Utilizing Physiologic Information From Spire Health Tags to Identify Heart Failure Patients At-Risk for Hospital Readmission A Pilot Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
A-SPIRE-HF
Brief Summary:
To evaluate the use of the Spire Health Tags in heart failure patients to determine the feasibility of capturing signals of respiration pulse rate activity sleep patterns and stress levels following HF hospitalization
Detailed Description:
Over 5 million Americans suffer from heart failure HF and treating HF as a chronic condition is associated with significant costs In addition about 24 of the patients discharged with a primary diagnosis of HF are readmitted to the hospital within 30 days representing a significant public health burden While there have been efforts to predict and reduce 30-day hospital readmission initiated by the Centers for Medicare and Medicaid Services CMS no studies utilized daily physiologic data from wearables to identify at-risk patients
The overall goal of this proposed pilot feasibility study is to utilize the Spire Health Tags in a heart failure patient population to ascertain the feasibility of capturing appropriate signals of respiration pulse rate activity sleep patterns and stress levels calmfocusedtense during the day for 80 of the time in patients following HF hospitalization for a 30-day period The investigators will do exploratory analysis of the changes in these physiologic variables during a 30-day period following HF hospitalization to identify risk markers that could predict 30-day readmission
The overall goal of this proposed pilot feasibility study is to utilize the Spire Health Tags in a heart failure patient population to ascertain the feasibility of capturing appropriate signals of respiration pulse rate activity sleep patterns and stress levels calmfocusedtense during the day for 80 of the time in patients following HF hospitalization for a 30-day period The investigators will do exploratory analysis of the changes in these physiologic variables during a 30-day period following HF hospitalization to identify risk markers that could predict 30-day readmission
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