Heart Failure
Conditions
Keywords
Acute Heart Failure, Chronic Heart Failure, Home care services, Cost-Benefit Analysis, Quality of life
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHOME-based hospitalization
patients in Home care treatment (HC) group will be treated at home
Sponsors
Agence Regionale de Sante d'Ile de France
French Cardiology Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute heart failure (with history of Chronic Heart Failure) * Identified in the first 48 hours * Eligible for home-care with Hospitalisation à Domicile within 4 days after hospitalization. * Patient affiliated to social security and to complementary health insurance
Exclusion criteria
* Under 18 years old * Predominantly left-sided heart failure, dependent on oxygen because of the congestion * Unexplored heart failure, indication of specific techniques (angiography) of device implantations (ICD, CRT). * Severe cognitive disorders. Behavior disorders. * Severe renal dysfunction with eGFR (MDRD) \< 15 mL/min/1.73m2 * Patient leaving alone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to rehospitalization | within the first 3 months after the randomization. | Time to rehospitalization for a new episode of acute heart failure within the first 3 months after the randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status | at the end of the treatment and 3 months | 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. |
| Mortality at the end of the treatment, 3 months and 1 year | at the end of the treatment, 3 months and 1 year | Mortality at the end of the treatment, 3 months and 1 year |
| Time to first rehospitalization | within the first year after the randomization. | Time to first rehospitalization for a new episode of acute heart failure within the first year after the randomization. |
| Occurrence of adverse events | during hospitalization at the end of the IV treatment which will be different for each patient, average of 15 days | Occurrence of adverse events evaluated at the end of the IV treatment which will be different for each patient. |
| Quality of life (scales) | at the end of the treatment and 3 months | Quality of life (scales) at the end of the treatment and 3 months |
| Cost-effectiveness | at the end of the treatment, 3 months and 1 year | Cost-effectiveness at the end of the treatment, 3 months and 1 year |
Countries
France
Outcome results
None listed