Efficacy of PRADO Heart Failure in Occitania

NCT ID: NCT03396081

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-04

Study Completion Date

2022-05-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PRADO-IC

Group Type EXPERIMENTAL

PRADO-IC

Intervention Type BEHAVIORAL

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.

Usual care

Group Type OTHER

No intervervention Usual Care

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

No intervervention Usual Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Montpellier

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Roubille F, Labarre JP, Georger F, Galinier M, Herman F, Berdague P, Nogue E, Petroni T, Delbaere Q, Malak A, Robin M, Prunet E, Leclercq F, Pasquie JL, Papinaud L, Mercier G, Ricci JE, Cayla G, Duflos C. PRADOC: A Multicenter Randomized Controlled Trial to Assess the Efficiency of PRADO-IC, a Nationwide Pragmatic Transition Care Management Plan for Hospitalized Patients With Heart Failure in France. J Am Heart Assoc. 2024 Aug 6;13(15):e032931. doi: 10.1161/JAHA.123.032931. Epub 2024 Jul 18.

Reference Type DERIVED
PMID: 39023055 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-A01732-51

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL17_0113

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Interval Training in Heart Failure
NCT03955029 RECRUITING NA