Echocardiography in Nursing Home (ECHOGER)

December 2, 2025 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

1050

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Echocardiographic screening arm
Participants from nursing homes allocated to echocardiographic screening group will benefit of one echocardiography at inclusion.
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.
No Intervention: Usual care
Participants from nursing homes allocated to no-screening group. Participants will be followed for medical management and care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count of resident presenting a heart failure decompensation
Time Frame: 12 months
Number of residents with heart failure flare (worsening of at least 1 NYHA class) or unplanned hospitalization for heart failure
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of a clinically significative change in medical management and care in the month following ultrasound
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

Directorate of Health Care Supply

Investigators

  • Principal Investigator: Thierry LE TOURNEAU, PU-PH, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC22_0449

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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