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Clinical Trials/NCT04703504
NCT04703504
Terminated
Not Applicable

RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization

French Cardiology Society8 sites in 1 country25 target enrollmentJuly 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Decompensation
Sponsor
French Cardiology Society
Enrollment
25
Locations
8
Primary Endpoint
Number of participants with a re-hospitalization due to heart decompensation
Status
Terminated
Last Updated
last year

Overview

Brief Summary

The prevalence of heart failure (HF) is constantly increasing in France due to the aging of the population, better management of etiological factors and improved treatments (drug / interventional). On the other hand, re-hospitalizations for heart failure continue to increase, exceeding reception capacities and constitute a real challenge for current public health systems. The PRADO system provides administrative support (through a health insurance advisor) in the management of patient appointments with their doctors as well as home visits by a nurse trained in heart failure. Other interventional medical and educational interventions performed during an out-of-hospital consultation guided by a computer platform would help to optimize the care and continuity of care.

Detailed Description

The aim of this study is to demonstrate the value of a multiple intervention program in reducing early readmissions for heat failure in patients hospitalized for cardiac decompensation. This work will create an interventional assistance program to structure the exit consultation in order to optimize treatment, educate patients, ensure the continuity of hospital-city care and improve compliance (reminders) to reduce re-hospitalizations. This program will be carried out by using a computer platform allowing the systematization of output documents and the sending of messages (e-mail / SMS) for making appointments (medical consultations, biologicals sampling) and perfect therapeutic education.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
September 20, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
French Cardiology Society
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Heart decompensation requiring hospitalization and the use of intravenous diuretic therapy
  • Left Ventricular Ejection Fraction ≤ 40%.

Exclusion Criteria

  • Hospitalization for cardiac decompensation leading to an invasive procedure (valve, coronary, etc.).
  • Acute reversible cause of heart failure.
  • Incurable disease (other than heart failure) or estimated life expectancy of less than one year.
  • Patient transferred directly to another department or cardiac rehabilitation center.
  • Significant cognitive impairment.
  • Patient without cell phone or email.
  • Linguistic or psychic refusal or inability to sign the informed consent.
  • Current participation in a clinical tria

Outcomes

Primary Outcomes

Number of participants with a re-hospitalization due to heart decompensation

Time Frame: 3 months

Defined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.

Secondary Outcomes

  • Number of participants with death(12 months)
  • Number of participants with a re-hospitalization due to heart decompensation(12 months)
  • Number of re-hospitalization due to heart decompensation per patient(12 months)
  • Delay between discharge and re-hospitalization due to heart decompensation(12 months)
  • Rate of pacemaker implantation(12 months)

Study Sites (8)

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