Research Into Factors Determining Participation in 2 Interventions Modifying the Care Pathways of Patients With Heart Failure: PRADO and Telemedicine

NCT ID: NCT05417490

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-04-01

Brief Summary

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.

Detailed Description

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.

1. 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.

2. 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.

3. 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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group with PRADO

All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.

Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M (6 months) visits are part of the usual follow-up of patients hospitalized for heart failure.

Administration of questionnaires:

• Girerd's questionnaire : The objective is to measure the medication compliance of patients during treatment
• SSQ6 (Social Support Questionnaire 6) : which measures two dimensions of social support (satisfaction and availability). SSQ6 is an abbreviated form of SSQ (Social Support Questionnaire). A high SSQ score indicates more optimism about life than a low score.

PRADO-IC

Intervention Type: 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.

Group with PRADO + remote monitoring

All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.

Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month optional only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M visits are part of the usual follow-up of patients hospitalized for heart failure.

Administration of questionnaires:

• Girerd's questionnaire
• SUTAQ (Service User Technology Acceptability Questionnaire) : only for patients with remote monitoring.

the questionnaire has 22 items, measured on a Likert scale from 1 to 6, reflecting respectively more or less agreement with the statements of the items. The questionnaire has 5 subscales, each containing between 3 and 9 items.

• SSQ6

PRADO-IC

Intervention Type: 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

Intervention Type: 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.

Group with remote monitoring

All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.

Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month optional only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M visits are part of the usual follow-up of patients hospitalized for heart failure.

Administration of questionnaires:

• Girerd's questionnaire on therapeutic compliance
• SUTAQ inspired digital tools acceptability questionnaire: only for patients with remote monitoring
• SSQ6 social support questionnaire

Remote monitoring

Intervention Type: 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.

Group without intervention

All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.

Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month optional only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M visits are part of the usual follow-up of patients hospitalized for heart failure.

Administration of questionnaires:

• Girerd's questionnaire on therapeutic compliance
• SSQ6 social support questionnaire

No interventions assigned to this group

Interventions

PRADO-IC

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.

Intervention Type: OTHER

Remote monitoring

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François ROUBILLE, PUPH

Role: PRINCIPAL_INVESTIGATOR

UH of Montpellier

Locations

University Hospital, Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

François ROUBILLE, PUPH

Role: CONTACT

f-roubille@chu-montpellier.fr

4.67.33.61.82 ext. +33

Facility Contacts

François ROUBILLE, PUPH

Role: primary

f-roubille@chu-montpellier.fr

Other Identifiers

RECHMPL20_0018

Identifier Type: -

Identifier Source: org_study_id