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

NCT ID: NCT04703504

Last Updated: 2024-10-04

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

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2024-09-20

Brief Summary

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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

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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.

Conditions

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Heart Decompensation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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multi-intervention

* Automatic creation of discharge prescription (personalized checklist of possible therapeutic optimizations generated from clinical data entered into the platform. This checklist will comply with the recommendations on altered left ventricular ejection fraction from European Society of Cardiology 2016.
* Automatic creation of documents for patient:

* Reminder letter to make an appointment with his general practitioner (at 7 days) and cardiologist (1 month) and to report the prescribed blood test.
* Drug prescription.
* Prescription for blood tests (5 days and 25 days before seeing the general practitioner and cardiologist).
* Therapeutic education documents
* Patients will receive numerous messages (SMS / e-mail) in order to 1 / not forget their medical appointments, 2 / not to forget to make and bring back their blood test for the consultation, 3 / to perfect the therapeutic education advice provided previously

Group Type EXPERIMENTAL

Multiple intervention program

Intervention Type OTHER

Support for patient follow-up assisted by a computer program

Control

Discharge prescription according to the investigator's habits.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multiple intervention program

Support for patient follow-up assisted by a computer program

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

French Cardiology Society

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud GALAT, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Henri Mondor, Créteil

Locations

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Hôpital Paul d'Egine

Champigny-sur-Marne, , France

Site Status

Hôpital Henri Mondor

Créteil, , France

Site Status

Hôpital Simone Veil

Eaubonne, , France

Site Status

Hôpitaux Nord-Ouest de Villefranche

Gleizé, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Polyclinique de Poitiers

Poitiers, , France

Site Status

Centre Cardiologique du Nord

Saint-Denis, , France

Site Status

Centre Hopsitalier Lucie et Raymond Aubrac

Villeneuve-Saint-Georges, , France

Site Status

Countries

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France

Other Identifiers

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2016-06

Identifier Type: -

Identifier Source: org_study_id

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