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| Name | Class |
|---|---|
| Agence Regionale de Sante d'Ile de France | OTHER_GOV |
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Evaluation of the efficacy, safety and and cost of home care versus conventional hospitalization care at 3-months in patients with worsening chronic heart failure.
Chronic heart failure (CHF) has an important socio-economic impact due to frequent hospital readmissions.
Hypothesis: Home care treatment (HC) will improve quality of live and decrease cost.
Methodology: Pilot, prospective, open, randomized controlled trial with 1-year follow-up for CHF patients admitted to 10 French hospital from March 2017 through February 2018, for acute decompensation of CHF. Patients will be randomly assigned to conventional hospital care or to the HC and treated with intravenous diuretics. Following discharge within 48 hours from the hospital, patients in the HC group will be treated at home. Follow-up will be conducted for both groups at discharge, 3 and 12 months after inclusion in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients will be randomly assigned to conventional hospital care | |
| Home care treatment | Experimental | Patients will be randomly assigned to the HOME-based hospitalization and treated with intravenous diuretics. Following discharge within 48 hours from the hospital, patients in the HC group will be treated at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HOME-based hospitalization | Procedure | patients in Home care treatment (HC) group will be treated at home |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to rehospitalization | Time to rehospitalization for a new episode of acute heart failure within the first 3 months after the randomization. | within the first 3 months after the randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | Occurrence of adverse events evaluated at the end of the IV treatment which will be different for each patient. | during hospitalization at the end of the IV treatment which will be different for each patient, average of 15 days |
| Quality of life (scales) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thibaud DAMY, MD | CH HENRI MONDOR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor | Créteil | 94000 | France | |||
| Hôpital Bicêtre |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Quality of life (scales) at the end of the treatment and 3 months |
| at the end of the treatment and 3 months |
| Nutritional status | Evaluation of the nutritional status based on MNA score at the beginning of the IV treatment and 3 months and dietary survey at the beginning and the end of the IV treatment. | at the end of the treatment and 3 months |
| Mortality at the end of the treatment, 3 months and 1 year | Mortality at the end of the treatment, 3 months and 1 year | at the end of the treatment, 3 months and 1 year |
| Cost-effectiveness | Cost-effectiveness at the end of the treatment, 3 months and 1 year | at the end of the treatment, 3 months and 1 year |
| Time to first rehospitalization | Time to first rehospitalization for a new episode of acute heart failure within the first year after the randomization. | within the first year after the randomization. |
| Le Kremlin-Bicêtre |
| 94275 |
| France |