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Recruiting NCT06445231

Echocardiography in Nursing Home

No phase Interventional Heart Diseases Heart Failure Heart Valve Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implementation of echocardiography in nursing homes.
Who it may be relevant to
Registry conditions: Heart Diseases, Heart Failure, Heart Valve Diseases. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Count of resident presenting a heart failure decompensation [Time frame: 12 months]
Secondary outcome measures (1)
  • Presence of a clinically significative change in medical management and care in the month following ultrasound [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

France · 1 center
  • Nantes University Hospital — Nantes

Identifiers

NCT: NCT06445231 · RC22_0449

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗