Efficacy of PRADO Heart Failure in Occitania (PRADO-IC)

University Hospital Center (CHU)

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: PRADO-IC; Behavioral: No intervervention Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03396081

RECHMPL17_0113

2017-A01732-51 (Registry Identifier)

Details and patient eligibility

About

Patients with heart failure (IC), after hospitalization, have a marked fragility: in France, in the first year, 29% die and 45% are readmitted to IC. Interventions improving the coordination of care providers at the time of discharge from hospitalization were tested; they showed a reduction in readmissions for IC (relative risk (RR) from 0.51 to 0.74) and all-cause mortality (RR 0.75 to 0.87). The Patient Return Program IC (PRADO IC), set up by the Health Insurance, offers assistance in the initiation of outpatient medical monitoring, and a nursing follow-up of 2 to 6 months depending on the patient's severity. The trial of PRADO began in the second half of 2013, and the first evaluation showed that the time to first treatment was significantly shorter, and that the readmissions rate and the 6-month death rate were unchanged.

This study was of epidemiological type, comparative before-elsewhere. The difficulty of controlling for confounders in this type of study limits the scope of these conclusions. The efficacy hypothesis of PRADO IC is therefore always posed in the French context

Enrollment: 404 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Hospitalization for heart failure
• Subject living at home
• Informed consent

Exclusion criteria

• discharge to a rehabilitation clinic or to medical home for elderly people
• subject without health insurance
• terminal kidney failure
• programmed heart surgery
• waiting for heart transplantation
• psycho-cognitive impairment
• patient not autonomous for mobility at home
• supportive care
• planned move to medical home for elderly people in the coming 6 months
• no fluent french
• not able to provide informed consent
• participating to other study

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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404 participants in 2 patient groups

PRADO-IC

Experimental group

Treatment:

Behavioral: PRADO-IC

Usual care

Other group

Treatment:

Behavioral: No intervervention Usual Care