Echocardiography in Nursing Home

Heart Failure Clinical Trial

— ECHOGER  

Official title:

Implementation and Effectiveness of Screening Echocardiography Performed in Nursing Home: ECHOGER

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06445231
• Other study ID #: RC22_0449
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 1, 2029

Study information

• Verified date: May 2024
• Source: Nantes University Hospital
• Contact: Thierry LE TOURNEAU, PU-PH
• Phone: 33 2 40 16 54 98
• Email: thierry.letourneau[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1050
• Est. completion date: September 1, 2029
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria :

Nursing homes residents with a life-expectancy estimated > 1 year, and able to participate to the study, giving an oral consent

Exclusion Criteria :

• no accessible to echocardiography

• closed unit (severe Alzheimer disease…)

• recent contagious disease such Covid (<15 days)

• no consent to participate

• no social security number

Related Conditions & MeSH terms

• Heart Diseases
• Heart Failure
• Heart Valve Diseases

Intervention

Diagnostic Test:
• Implementation of echocardiography in nursing homes
An ultrasound will be carried out in the EHPAD, the result of which will be interpreted by a cardiologist then sent to the establishment and the attending physician with instructions to follow.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Directorate of Health Care Supply

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count of resident presenting a heart failure decompensation	Number of residents with heart failure flare (worsening of at least 1 NYHA class) or unplanned hospitalization for heart failure	12 months
Secondary	Presence of a clinically significative change in medical management and care in the month following ultrasound	A binary outcome will be constructed, based on the following algorithm: clinically significative change set to "yes" if a change in ongoing drug prescription is observed, and/or a cardiologist visit is planned, and/or a geriatrist visit is planned, and/or an hospitalization for clinical work-up is set, and/or a resume of the ultrasound is sent to the GP. Otherwise (all components set to "absent"), this outcome will be set to "None".	12 months