Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05417490

Factors Influencing Participation in PRADO and Telemedicine Interventions in Heart Failure

Patients with heart failure (HF), after hospitalization, present a marked fragility. Interventions improving the coordination of care actors at the time of discharge from hospitalization have been tested and have shown, in preliminary studies, a reduction in rehospitalizations for heart failure and all-cause mortality.

Among these promising devices, two have recently been deployed nationwide.

* The return home program for IC patients (PRADO IC), set up by the Health Insurance, aims to facilitate the return and stay at home after hospitalization. It offers assistance with the initiation of outpatient medical follow-up, nursing follow-up for 2 to 6 months depending on the severity of the patient, and a follow-up log facilitating the exchange of information. * At the same time, as part of the ETAPES (Telemedicine experiments for the improvement of healthcare pathways) program of the Health Insurance, the deployment of telemedicine for remote monitoring of heart failure pursues a comparable objective of reducing rehospitalizations.

These two systems are widely deployed on a national scale, and are intended to be universal.

Our hypothesis is that adherence to care transition and telemedicine programs, and therefore their effectiveness, may depend on their association, as well as socio-demographic, cultural, and geographical factors.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Montpellier

Montpellier, France

Location status: Recruiting

Location contact

François ROUBILLE, PUPH

CONTACT

[email protected]

About this study

Patients with heart failure (HF), after hospitalization, present a marked fragility: in France, in the first year, 29% die and 45% are rehospitalized for HF. Interventions improving the coordination of care actors at the time of discharge from hospitalization have been tested and have shown in preliminary studies a reduction in rehospitalizations for HF (relative risk (RR) from 0.51 to 0.74) and all-cause mortality (RR 0.75 to 0.87).

Among these promising devices, two have recently been deployed nationwide.

  • The return home program for IC patients (PRADO IC), set up by the Health Insurance, aims to facilitate the return and stay at home after hospitalization. It offers assistance with the initiation of outpatient medical follow-up, nursing follow-up for 2 to 6 months depending on the severity of the patient, and a follow-up log facilitating the exchange of information. It is based on the assumption that these actions will improve the coordination of care between the hospital and the city, and between home nurses and doctors. In addition, nurses reinforce therapeutic patient education (TPE), whether or not it is initiated in a setting dedicated to TPE.
  • At the same time, as part of the ETAPES program of the Health Insurance, the deployment of telemedicine for remote monitoring of heart failure pursues a comparable objective of reducing rehospitalizations. It is based on the hypothesis that the early signs of cardiac decompensation can be diagnosed by telemonitoring and trigger earlier and therefore less aggressive management for similar effectiveness.

These two systems are widely deployed on a national scale, and are intended to be universal.

However, three points can call into question the effectiveness of this deployment: their evaluation is often difficult, the extrapolability of randomized studies to health systems and different populations is low, and the complementarity of two independently constructed programs has never been been studied so far.

  • The preliminary data concerning the PRADO were epidemiological, historical, comparative before-elsewhere, on the SNIIRAM (National health insurance inter-scheme information system) databases, without optimal consideration of clinical and cultural confounding factors.
  • The acceptability of these programs by all health professionals (and therefore how they choose to deploy such and such a system for a given patient) and patients in the French context is not known.
  • The PRADO system and telemedicine solutions, acting differently, could be synergistic and therefore multiply the benefits obtained. However, in practice, some patients experience these programs as intrusive, and it is possible that their adherence is in fact all the worse when two programs are implemented. Similarly, from the prescriber's point of view, the way in which the various possible combinations are chosen is unknown.

The answer to these three questions is necessary to guide the most effective deployment of these programs nationwide.

Our hypothesis is that adherence to care transition and telemedicine programs, and therefore their effectiveness, may depend on their association, as well as socio-demographic, cultural, and geographical factors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient
  • Patient hospitalized at the time of inclusion for cardiac decompensation, or cause of admission for which heart failure plays a decisive or aggravating role (co-infection, etc.) recognized by the clinician.
  • Patient agreeing to take part in this research (absence of non-objection)

Exclusion criteria

  • Refusal to participate
  • Pregnant or breastfeeding women, patients unable to give protected adult consent, vulnerable people (art.L.1121-6, L.1121-7, L.1211-8, L.1211-9)
  • Subject deprived of liberty by judicial or administrative decision

Treatment and study plan

PRADO-IC

Other

The CAM (Health Insurance Advisor) are part of the staff of the Primary Health Insurance Funds (CPAM). They are physically present in the establishments participating in the PRADO.

They are facilitators between city health professionals and the patient for their return home.

They assist the patient in making appointments with their general practitioner, their cardiologist, and the IDE (general care nurses) trained at PRADO-IC who will make the home visits.

After returning home, the CAM verifies, by two telephone calls at 1 week and 2 months, that the patient has initiated his outpatient follow-up.

IDE, trained in the therapeutic education of the IC patient according to the PRADO-IC device, carry out:

  • for NYHA (New York Heart Association) 1-2 patients: 8 home visits in two months.
  • for NYHA 3-4 patients: 8 home visits in 2 months, upon confirmation and prescription from the physician, 8 visits in the following 4 months.

The doctor carries out a long consultation at 2 months.

remote monitoring

Device

Chronic Care Connect is intended for remote medical monitoring of patients suffering from chronic heart failure.

It consists of a web application (named NOMHADChronic™) and non-medical remote human assistance performed by qualified personnel.

Non-medical human assistance allows the following steps to be carried out:

  • characterization of alerts
  • structured follow-up of remote patients.

This non-medical human assistance is provided by:

  • nurses trained in therapeutic education and cardiology, Customer Relations Advisors, and logisticians.

Weight and symptoms (listed in an 8-question questionnaire) are collected respectively using a connected scale and the mobile application.

It allows, via a web browser:

  • to the personnel constituting the non-medical human assistance, to have access to the health data of the patients
  • remote monitoring doctors, to have access to the health data of each of their own patients, and to carry out medical remote monitoring procedures.

Primary outcomes

  1. Percentage of patients participating in heart failure programs at 1 month

    Time frame: At 1 month

    Participation corresponds to:

    • for the PRADO group: visits to the attending physician and home nurses, and appointments made with the cardiologist
    • for the remote monitoring group: completion of at least 80% of the weighings
  2. Percentage of patients participating in heart failure programs at 6 months

    Time frame: At 6 months

    Participation corresponds to:

    • for the PRADO group: visits to the attending physician and home nurses, and appointments made with the cardiologist
    • for the remote monitoring group: completion of at least 80% of the weighings
    • for the group without intervention: completion of the visit at 6 months

Secondary outcomes

  1. Number of non-participation of patients

    Time frame: At inclusion

    Describe the causes of non-participation, primary (when the intervention was proposed)

  2. Number of non-participation of patients

    Time frame: through study completion, an average of 6 months

    Describe the causes of non-participation secondary (after initial acceptance)

  3. Percentage effectiveness of pathology programs at 1 month

    Time frame: between inclusion and 1 month

    Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for all causes combined

  4. Percentage effectiveness of pathology programs at 1 month

    Time frame: between inclusion and 1 month

    Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for heart failure

  5. Percentage effectiveness of pathology programs at 1 month

    Time frame: between inclusion and 1 month

    Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths from all causes combined

  6. Percentage effectiveness of pathology programs at 1 month

    Time frame: between inclusion and 1 month

    Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths due to heart failure

  7. Percentage effectiveness of pathology programs at 6 months

    Time frame: between inclusion and 6 months

    Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for all causes combined

  8. Percentage effectiveness of pathology programs at 6 months

    Time frame: between inclusion and 6 months

    Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for heart failure

  9. Percentage effectiveness of pathology programs at 6 months

    Time frame: between inclusion and 6 months

    Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths from all causes combined

  10. Percentage effectiveness of pathology programs at 6 months

    Time frame: between inclusion and 6 months

    Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths due to heart failure

  11. percentage of effectiveness on the course of care at 6 months

    Time frame: between inclusion and 6 months

    Average number of consultations per month with the general practitioner

  12. percentage of effectiveness on the course of care at 6 months

    Time frame: between inclusion and 6 months

    Time between the first consultation with the general practitioner and discharge from hospital

  13. percentage of effectiveness on the course of care at 6 months

    Time frame: between inclusion and 6 months

    Average number of consultations per month with the cardiologist

  14. percentage of effectiveness on the course of care at 6 months

    Time frame: between inclusion and 6 months

    Time between the first consultation with the cardiologist and discharge from hospital

  15. percentage of days with at least one nursing contact

    Time frame: between inclusion and 6 months

    number of days with at least one nursing contact

  16. Number of emergency medical contacts

    Time frame: between inclusion and 6 months

    are considered as emergency contacts: consultations with emergency increase, or increase for Night, Weekend or Public Holiday; consultations in emergencies; hospitalizations with emergency entry mode

  17. percentage of medical appointments made

    Time frame: between inclusion and 6 months

    according to the continuity of care index, corresponding to the percentage of appointments made by patients with a doctor

  18. Average number of treatment days taken per patient per month

    Time frame: between inclusion and 6 months

    For taking sartans treatments

  19. Average number of treatment days taken per patient per month

    Time frame: between inclusion and 6 months

    For taking beta-blocker treatments

  20. Average number of treatment days taken per patient per month

    Time frame: between inclusion and 6 months

    Coefficient of variation of the daily dose of loop diuretics, calculated as the average dose between two deliveries

  21. percentage of efficiency on the cost of the care pathway at 6 months

    Time frame: between inclusion and 6 months

    Cost of care pathways: made up of production costs over 6 months after initial hospitalization, and includes all direct costs, whether medical or non-medical.

  22. percentage of physicians offering heart failure programs

    Time frame: between inclusion and 6 months

    Beliefs of physicians on the facilitating elements and on the obstacles of these programs

Study contacts

Contact information is provided by the study sponsor or research team.

François ROUBILLE, PUPH

CONTACT

[email protected]

4.67.33.61.82 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Research Into Factors Determining Participation in Two Interventions Modifying the Care Pathways of Patients With Heart Failure in Eastern Occitanie: PRADO-IC and Telemedicine

Acronym: PARTI-PARC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 14, 2022
Registry last updated
Apr 15, 2026

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.

Published trials that share one or more normalized conditions with this study.