Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445231
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-14
Brief Title:
Echocardiography in Nursing Home
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Implementation and Effectiveness of Screening Echocardiography Performed in Nursing Home ECHOGER
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ECHOGER
Brief Summary:
The study seeks to explore the implementation characteristics acceptability appropriateness feasibility adoption fidelity penetration implementation cost and sustainability of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes
Detailed Description:
Open-label cluster randomized type 1 hybrid trial with 2 parallel arms nursing homes will be randomized in the interventional echocardiography by sonographer or non-interventional arms usual care In the interventional arm echocardiography will be proposed to all residents of the nursing home at baseline Clinical management will be adapted to the result of echocardiography by the general practitioner in accordance with the cardiologist The main objective is to assess the impact at 12 months of the initial performance of a systematic simplified echocardiography on the rate of nursing home residents presenting with heart failure episode or cardiovascular pathology The Primary endpoint is the number of nursing home residents presenting a heart failure episode or an unscheduled hospitalization for heart failure or other cardiovascular pathologies at 12 months
Thirty nursing homes and 1050 residents will be included overall
Thirty nursing homes and 1050 residents will be included overall
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