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

NCT04703504 | Terminated

• 1 other identifier: 2016-06
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

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.

Conditions

Heart Decompensation

Keywords

heart failure; multiple intervention program

Outcome Measures

Primary Outcomes (1)

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

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

  3 months

Secondary Outcomes (6)

• 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

• Number of participants with death

  3 months

• Number of participants with death

  12 months

Study Arms (2)

multi-intervention

EXPERIMENTAL

* 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

Other: Multiple intervention program

Control

NO INTERVENTION

Discharge prescription according to the investigator's habits.

Interventions

Multiple intervention program OTHER

Support for patient follow-up assisted by a computer program

multi-intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• French Cardiology Society: lead
• Bayer: collaborator

Study Sites (8)

Hôpital Paul d'Egine

Champigny-sur-Marne, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Hôpital Simone Veil

Eaubonne, France

Location

Hôpitaux Nord-Ouest de Villefranche

Gleizé, 69655, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Polyclinique de Poitiers

Poitiers, 86000, France

Location

Centre Cardiologique du Nord

Saint-Denis, France

Location

Centre Hopsitalier Lucie et Raymond Aubrac

Villeneuve-Saint-Georges, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Arnaud GALAT, MD

  CHU Henri Mondor, Créteil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: July 15, 2022
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)