NCT03396081

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 4, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
Last Updated

September 30, 2025

Status Verified

May 1, 2022

Enrollment Period

4 years

First QC Date

December 26, 2017

Last Update Submit

September 24, 2025

Conditions

Heart Failure

Keywords

Heart FailureCare pathwayTransition programEfficiency

Outcome Measures

Primary Outcomes (1)

  • Cost-efficacy ratio

    Cost to avoid an hospitalization for heart failure

    12 months

Secondary Outcomes (6)

  • Cost-utility ratio

    12 months

  • Number of hospitalization for heart failure

    12 months

  • Number of all causes hospitalization

    12 months

  • Rate of death from cardiovascular disease

    12 months

  • Number of general practitionner

    12 months

  • +1 more secondary outcomes

Study Arms (2)

PRADO-IC

EXPERIMENTAL
Behavioral: PRADO-IC

Usual care

OTHER
Behavioral: No intervervention Usual Care

Interventions

PRADO-ICBEHAVIORAL

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.

PRADO-IC
No intervervention Usual CareBEHAVIORAL

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

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 39023055DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 10, 2018

Study Start

May 4, 2018

Primary Completion

May 9, 2022

Study Completion

May 9, 2022

Last Updated

September 30, 2025

Record last verified: 2022-05

Locations

FR(1)