Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814562
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-04-03
Brief Title:
Cardiovascular Precision Medicine Remote Intervention
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Cardiovascular Precision Medicine Remote Intervention - Pilot Protocol
Status:
ACTIVE_NOT_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:
CPR
Brief Summary:
This exploratory proof of concept study aims to evaluate whether it is possible to identify at-risk patients based on EHR review of blood pressure fluctuation over time and cholesterol levels recruit those patients and engage them in a remote intervention protocol
Detailed Description:
Patients will be screened for participation based on EHR blood pressure measurements Those who potential meet the prespecified criteria will be approached during a clinic visits about participation in the study Patients who agree to participate and sign an informed consent will be given an automatic blood pressure monitor and their contact details will be obtained in order to enable administration of the intervention
The interventions theoretical underpinnings are principles previously identified as promising or helpful in health care management of at-risk patients The principles are
1 Hovering using a risk marker to guide an intervention
2 Addressing posttraumatic avoidance as a way to improve adherence using an imaginal exposure paradigm
3 Using a remote interventionist via a telemetric interface that involves active dynamic patient engagement rather than automated processes
The interventions theoretical underpinnings are principles previously identified as promising or helpful in health care management of at-risk patients The principles are
1 Hovering using a risk marker to guide an intervention
2 Addressing posttraumatic avoidance as a way to improve adherence using an imaginal exposure paradigm
3 Using a remote interventionist via a telemetric interface that involves active dynamic patient engagement rather than automated processes
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?:
False
Is an FDA AA801 Violation?:
None