Echocardiography in Nursing Home

NCT ID: NCT06445231

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1050 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-02

Study Completion Date

2030-01-01

Brief Summary

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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

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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

Conditions

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Heart Diseases Heart Failure Heart Valve Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Nursing home randomization in 1:1 ratio between echocardiography and no-echocardiography
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Not relevant

Study Groups

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Echocardiographic screening arm

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

Group Type EXPERIMENTAL

Implementation of echocardiography in nursing homes

Intervention Type DIAGNOSTIC_TEST

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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Directorate of Health Care Supply

UNKNOWN

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry LE TOURNEAU, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, Loire-Atlantique, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Thierry LE TOURNEAU, PU-PH

Role: CONTACT

33 2 40 16 54 98

Anne-Sophie BOUREAU, PH

Role: CONTACT

33 2 40 16 85 35

Facility Contacts

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Thierry LE TOURNEAU, PU-PH

Role: primary

33 2 40 16 54 98

Anne-Sophie BOUREAU, PH

Role: backup

33 2 40 16 85 35

Other Identifiers

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RC22_0449

Identifier Type: -

Identifier Source: org_study_id

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