Efficacy of PRADO Heart Failure in Occitania

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: PRADO-IC; Behavioral: No intervervention Usual Care

• Registration Number: NCT03396081
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Study Start: 2018-05-04
• Status Verified: 2022-05
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-09
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PRADO-IC	PRADO-IC	-
Usual care	No intervervention Usual Care	-

Primary Outcome Measures

Name	Time	Method
Cost-efficacy ratio	12 months	Cost to avoid an hospitalization for heart failure

Secondary Outcome Measures

Name	Time	Method
Number of general practitionner	12 months	Claim data
Number of cardiologist visits	12 months	Claim data
Cost-utility ratio	12 months	Cost will be performed from the society perspective. Utility will be derived from the French EQ5D, measured at 0, 6 and 12 months
Number of hospitalization for heart failure	12 months	Hospitalizations for heart failure will be defined using claim data.
Rate of death from cardiovascular disease	12 months
Number of all causes hospitalization	12 months

Trial Locations

Locations (1)

CHU Montpellier; 🇫🇷 Montpellier, France