Heart FailurePARTI-PARCNCT05417490
Factors Influencing Participation in PRADO and Telemedicine Interventions in Heart Failure
An observational study of Heart Failure, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- PRADO-IC and Remote monitoring
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2025to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population consists of adult patients, suffering from heart failure, hospitalized for cardiac decompensation. The source population consists of patients hospitalized for heart failure in cardiology departments of UH of Montpellier, Nîmes, Bassin de Thau and Béziers.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital, Montpellier
Montpellier
François ROUBILLE, PUPH, f-roubille@chu-montpellier.fr
About this study
Official 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
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.
Read more
- 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.
Read the 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.
- 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.
- Conditions
- Heart Failure
- Being tested
- PRADO-IC, Remote monitoring
- Keywords
- heart failure, transitional care, PRADO, remote monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRADO-ICOther
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 monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PRADO-IC | |
| 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 Receives: Other: PRADO-IC; Device: Remote monitoring | |
| 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 Receives: Device: Remote monitoring | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients participating in heart failure programs 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
Measured: At 1 month
Percentage of patients participating in heart failure programs 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
Measured: At 6 months
Secondary outcomes (22)
Number of non-participation of patients
Describe the causes of non-participation, primary (when the intervention was proposed)
Measured: At inclusion
Number of non-participation of patients
Describe the causes of non-participation secondary (after initial acceptance)
Measured: through study completion, an average of 6 months
Percentage effectiveness of pathology programs at 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
Measured: between inclusion and 1 month
Percentage effectiveness of pathology programs at 1 month
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for heart failure
Measured: between inclusion and 1 month
Percentage effectiveness of pathology programs at 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
Measured: between inclusion and 1 month
Percentage effectiveness of pathology programs at 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
Measured: between inclusion and 1 month
Percentage effectiveness of pathology programs at 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
Measured: between inclusion and 6 months
Percentage effectiveness of pathology programs at 6 months
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for heart failure
Measured: between inclusion and 6 months
Percentage effectiveness of pathology programs at 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
Measured: between inclusion and 6 months
Percentage effectiveness of pathology programs at 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
Measured: between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Average number of consultations per month with the general practitioner
Measured: between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Time between the first consultation with the general practitioner and discharge from hospital
Measured: between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Average number of consultations per month with the cardiologist
Measured: between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Time between the first consultation with the cardiologist and discharge from hospital
Measured: between inclusion and 6 months
percentage of days with at least one nursing contact
number of days with at least one nursing contact
Measured: between inclusion and 6 months
Number of emergency medical contacts
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
Measured: between inclusion and 6 months
percentage of medical appointments made
according to the continuity of care index, corresponding to the percentage of appointments made by patients with a doctor
Measured: between inclusion and 6 months
Average number of treatment days taken per patient per month
For taking sartans treatments
Measured: between inclusion and 6 months
Average number of treatment days taken per patient per month
For taking beta-blocker treatments
Measured: between inclusion and 6 months
Average number of treatment days taken per patient per month
Coefficient of variation of the daily dose of loop diuretics, calculated as the average dose between two deliveries
Measured: between inclusion and 6 months
percentage of efficiency on the cost of the care pathway at 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.
Measured: between inclusion and 6 months
percentage of physicians offering heart failure programs
Beliefs of physicians on the facilitating elements and on the obstacles of these programs
Measured: between inclusion and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Apr 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François ROUBILLE, PUPH, Principal investigator, UH of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417490
- Sponsor's protocol ID
- RECHMPL20_0018
- Acronym
- PARTI-PARC
- Status last verified
- Apr 2026
- First submitted
- 2 Jun 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05417490
- Acronym / sponsor ID
- PARTI-PARC / RECHMPL20_0018
- Conditions
- Heart Failure
- Keywords
- heart failure, transitional care, PRADO, remote monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group with PRADO | – | Other: PRADO-ICAll 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. |
| Group with PRADO + remote monitoring | – | Other: PRADO-IC, Device: Remote monitoringAll 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 |
| Group with remote monitoring | – | Device: Remote monitoringAll 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population consists of adult patients, suffering from heart failure, hospitalized for cardiac decompensation. The source population consists of patients hospitalized for heart failure in cardiology departments of UH of Montpellier, Nîmes, Bassin de Thau and Béziers.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRADO-ICThe 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. | Other | Group with PRADO, Group with PRADO + remote monitoring |
| Remote monitoringChronic 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. | Device | Group with PRADO + remote monitoring, Group with remote monitoring |
Primary outcome
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
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
22 secondary outcomes
Number of non-participation of patients
Time frame: At inclusion
Number of non-participation of patients
Time frame: through study completion, an average of 6 months
Percentage effectiveness of pathology programs at 1 month
Time frame: between inclusion and 1 month
Percentage effectiveness of pathology programs at 1 month
Time frame: between inclusion and 1 month
Percentage effectiveness of pathology programs at 1 month
Time frame: between inclusion and 1 month
Percentage effectiveness of pathology programs at 1 month
Time frame: between inclusion and 1 month
Percentage effectiveness of pathology programs at 6 months
Time frame: between inclusion and 6 months
Percentage effectiveness of pathology programs at 6 months
Time frame: between inclusion and 6 months
Percentage effectiveness of pathology programs at 6 months
Time frame: between inclusion and 6 months
Percentage effectiveness of pathology programs at 6 months
Time frame: between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Time frame: between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Time frame: between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Time frame: between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Time frame: between inclusion and 6 months
percentage of days with at least one nursing contact
Time frame: between inclusion and 6 months
Number of emergency medical contacts
Time frame: between inclusion and 6 months
percentage of medical appointments made
Time frame: between inclusion and 6 months
Average number of treatment days taken per patient per month
Time frame: between inclusion and 6 months
Average number of treatment days taken per patient per month
Time frame: between inclusion and 6 months
Average number of treatment days taken per patient per month
Time frame: between inclusion and 6 months
percentage of efficiency on the cost of the care pathway at 6 months
Time frame: between inclusion and 6 months
percentage of physicians offering heart failure programs
Time frame: between inclusion and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François ROUBILLE, PUPH principal investigator
UH of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François ROUBILLE, PUPH (4.67.33.61.82 ext. +33, f-roubille@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients participating in heart failure programs at 1 month (time frame: At 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.