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

September 24, 2025 updated by: University Hospital, Montpellier

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRADO-IC
Behavioral: PRADO-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.
Other: Usual care
Behavioral: No intervervention Usual Care
Advices about the care pathway, provided by care givers. Prescription of home nurse's visits if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-efficacy ratio
Time Frame: 12 months
Cost to avoid an hospitalization for heart failure
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-utility ratio
Time Frame: 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
12 months
Number of hospitalization for heart failure
Time Frame: 12 months
Hospitalizations for heart failure will be defined using claim data.
12 months
Number of all causes hospitalization
Time Frame: 12 months
12 months
Rate of death from cardiovascular disease
Time Frame: 12 months
12 months
Number of general practitionner
Time Frame: 12 months
Claim data
12 months
Number of cardiologist visits
Time Frame: 12 months
Claim data
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2018

Primary Completion (Actual)

May 9, 2022

Study Completion (Actual)

May 9, 2022

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL17_0113
  • 2017-A01732-51 (Registry Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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