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OpenTrials
Completed

NCT Number: NCT03396081

Efficacy of PRADO Heart Failure in Occitania

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRADO-IC

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

No intervervention Usual Care

Behavioral

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

Primary outcomes

  1. Cost-efficacy ratio

    Time frame: 12 months

    Cost to avoid an hospitalization for heart failure

Secondary outcomes

  1. 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

  2. Number of hospitalization for heart failure

    Time frame: 12 months

    Hospitalizations for heart failure will be defined using claim data.

  3. Number of all causes hospitalization

    Time frame: 12 months

  4. Rate of death from cardiovascular disease

    Time frame: 12 months

  5. Number of general practitionner

    Time frame: 12 months

    Claim data

  6. Number of cardiologist visits

    Time frame: 12 months

    Claim data

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: PRADO-IC

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2018
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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