Echocardiography in Nursing Home (ECHOGER)

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Heart Valve Diseases; Heart Failure; Heart Diseases

Treatments: Diagnostic Test: Implementation of echocardiography in nursing homes

Study type: Interventional

Funder types: Other

Identifiers

NCT06445231

RC22_0449

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,050 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,050 participants in 2 patient groups

Echocardiographic screening arm

Experimental group

Description:

Participants from nursing homes allocated to echocardiographic screening group will benefit of one echocardiography at inclusion.

Treatment:

Diagnostic Test: Implementation of echocardiography in nursing homes

Usual care

No Intervention group

Description:

Participants from nursing homes allocated to no-screening group. Participants will be followed for medical management and care as usual.