Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Directorate of Health Care Supply | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Echocardiographic screening arm | Experimental | Participants from nursing homes allocated to echocardiographic screening group will benefit of one echocardiography at inclusion. |
|
| Usual care | No Intervention | Participants from nursing homes allocated to no-screening group. Participants will be followed for medical management and care as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation of echocardiography in nursing homes | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Count of resident presenting a heart failure decompensation | Number of residents with heart failure flare (worsening of at least 1 NYHA class) or unplanned hospitalization for heart failure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of a clinically significative change in medical management and care in the month following ultrasound | 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". |
Not provided
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 :
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thierry LE TOURNEAU, PU-PH | Contact | 33 2 40 16 54 98 | thierry.letourneau@chu-nantes.fr | |
| Anne-Sophie BOUREAU, PH | Contact | 33 2 40 16 85 35 | annesophie.boureau@chu-nantes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thierry LE TOURNEAU, PU-PH | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Recruiting | Nantes | Loire-Atlantique | 44093 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D006333 | Heart Failure |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Nursing home randomization in 1:1 ratio between echocardiography and no-echocardiography
Not provided
Not provided
Not relevant
Not provided
| 12 months |