Echocardiography in Nursing Home

Not Applicable

Recruiting

• Conditions: Heart Failure; Heart Diseases; Heart Valve Diseases
• Interventions: Diagnostic Test: Implementation of echocardiography in nursing homes

• Registration Number: NCT06445231
• Lead Sponsor: Nantes University Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-31
• Study First Posted: 2024-06-06
• Status Verified: 2024-10
• Study Start: 2024-10-02
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2028-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Echocardiographic screening arm	Implementation of echocardiography in nursing homes	Participants from nursing homes allocated to echocardiographic screening group will benefit of one echocardiography at inclusion.

Primary Outcome Measures

Name	Time	Method
Count of resident presenting a heart failure decompensation	12 months	Number of residents with heart failure flare (worsening of at least 1 NYHA class) or unplanned hospitalization for heart failure

Secondary Outcome Measures

Name	Time	Method
Presence of a clinically significative change in medical management and care in the month following ultrasound	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".

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France