Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900362
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2021-03-28
Brief Title:
Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure
Sponsor:
Saint Lukes Health System
Organization:
Saint Lukes Health System
Study Overview
Official Title:
Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
FAST-RPM-HF
Brief Summary:
Previous research has investigated the use of remote patient monitoring in various clinical contexts however there has not been a clinical trial examining use of the VitalCare platform for ambulatory management of heart failure This trial will serve as a pilot study examining the feasibility of use of the VitalCare platform for ambulatory heart failure management and examine the effect of remote patient monitoring on patient engagement To the investigators knowledge this will be the first study examining the effect of remote patient monitoring with the VitalCare platform on heart failure clinical outcomes such as hospitalization for heart failure exacerbations and emergency room visits for heart failure
Detailed Description:
The next step in determining the role of remote patient monitoring in the management of patients with heart failure is to better understand which patients are most likely to benefit from a more intensive outpatient management or simply conservative management The subject population is patients with mild HFrEF or HFpEF who are prone to readmission This patient population does not have implanted devices to supply objective data to evaluate patients volume status and therefore can be challenging to manage on an outpatient basis By providing regular data on weight blood pressure pulse oximetry electrocardiogram and heartlung sounds that is reviewed on a monthly basis this may allow a clinician greater insight into their patients clinical status and allow for a more accurate and timely intervention to prevent clinical deterioration Furthermore this should enhance patient engagement with their own health as well as with their healthcare provider This study would significantly add to the current knowledge of management of heart failure in an ambulatory patient population without implanted devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None