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Efficacy of PRADO Heart Failure in Occitania

Efficacy of PRADO Heart Failure in Occitania

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03396081
Acronym
PRADO-IC
Enrollment
404
Registered
2018-01-10
Start date
2018-05-04
Completion date
2022-05-09
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Care pathway, Transition program, Efficiency

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

Interventions

BEHAVIORALPRADO-IC

1. Help of administrative employees to schedule the first medical visits after an hospitalization for heart failure. 2. Home nurse's visiting program, during 2 to 6 months after the hospitalization for heart failure.

BEHAVIORALNo intervervention Usual Care

Advices about the care pathway, provided by care givers. Prescription of home nurse's visits if needed.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cost-efficacy ratio12 monthsCost to avoid an hospitalization for heart failure

Secondary

MeasureTime frameDescription
Number of hospitalization for heart failure12 monthsHospitalizations for heart failure will be defined using claim data.
Number of all causes hospitalization12 months
Cost-utility ratio12 monthsCost will be performed from the society perspective. Utility will be derived from the French EQ5D, measured at 0, 6 and 12 months
Number of general practitionner12 monthsClaim data
Number of cardiologist visits12 monthsClaim data
Rate of death from cardiovascular disease12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026