Factors Influencing Participation in PRADO and Telemedicine Interventions in Heart Failure

NCT05417490 | Recruiting

• 1 other identifier: RECHMPL20_0018
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; transitional care; PRADO; remote monitoring

Outcome Measures

Primary Outcomes (2)

• 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

  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

  At 6 months

Secondary Outcomes (22)

• Number of non-participation of patients

  At inclusion

• Number of non-participation of patients

  through study completion, an average of 6 months

• Percentage effectiveness of pathology programs at 1 month

  between inclusion and 1 month

• Percentage effectiveness of pathology programs at 1 month

  between inclusion and 1 month

• Percentage effectiveness of pathology programs at 1 month

  between inclusion and 1 month

Study Arms (4)

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.

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

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

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

Interventions

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.

Group with PRADO; Group with PRADO + remote monitoring

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.

Group with PRADO + remote monitoring; Group with remote monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Adult patient
• Patient agreeing to take part in this research (absence of non-objection)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital, Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• François ROUBILLE, PUPH

  UH of Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François ROUBILLE, PUPH

CONTACT

4.67.33.61.82; f-roubille@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 14, 2022
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

FR (1)