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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.
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.
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.
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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:
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.
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| Group with remote monitoring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
The doctor carries out a long consultation at 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients participating in heart failure programs at 1 month | Participation corresponds to:
| At 1 month |
| Percentage of patients participating in heart failure programs at 6 months | Participation corresponds to:
| At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of non-participation of patients | Describe the causes of non-participation, primary (when the intervention was proposed) | At inclusion |
| Number of non-participation of patients | Describe the causes of non-participation secondary (after initial acceptance) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François ROUBILLE, PUPH | Contact | 4.67.33.61.82 | +33 | f-roubille@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| François ROUBILLE, PUPH | UH of Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Montpellier | Recruiting | Montpellier | France |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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:
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|
| 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:
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| 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:
This non-medical human assistance is provided by:
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:
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| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | between inclusion and 6 months |
| percentage of days with at least one nursing contact | number of days with at least one nursing contact | 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 | 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 | between inclusion and 6 months |
| Average number of treatment days taken per patient per month | For taking sartans treatments | between inclusion and 6 months |
| Average number of treatment days taken per patient per month | For taking beta-blocker treatments | 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 | 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. | 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 | between inclusion and 6 months |