Remote Patient Monitoring for Patients With Heart Failure in France

Heart Failure Clinical Trial

— TELESAT  

Official title:

Evaluating the Effectiveness of Remote Patient Monitoring (Satelia® Cardio) for Patients With Heart Failure (TELESAT Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06312501
• Other study ID #: 2021-0020 TELESAT
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: Satelia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this multicenter observational longitudinal cohort study is to evaluate the ability of a Remote Patient Monitoring (RPM) program to prevent cardiac decompensation by detecting weak signals of decompensation early in patients with chronic heart failure in France. The main question it aims to answer is whether an RPM solution can provide the improvement in overall patient survival Participants will answer to questionnaires provided by the RPM solution for the follow-up of their condition. Researchers will compare the following cohorts to see if RPM can improve their condition: - Cohort 1: using RPM for follow-ups. - Cohort 2: conventional care and not using any devices and solutions for the follow-ups.

Description:

TELESAT study is a national-scale observational prospective cohort study conducted in France from August 2018 to December 2022. The study was conducted using the French national health data system known as the Système National des Données de Santé (SNDS) which covers approximately 99% of the French population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• residing in France
• having heart failure
• adults over the age of 18 years
• New York Heart Association (NYHA) score=2 and Brain Natriuretic Peptid (BNP)>100 pg/ml or N-terminal pro BNP>1000 pg/ml OR prior hospitalization for heart failure

Exclusion Criteria:

• physician's assessment deemed patient not be physically or mentally able to be remotely monitored
• had chronic dialysis
• severe liver failure
• the presence of any other medical condition resulting in a less than one-year life expectancy,
• an estimated low adherence to treatment
• lack of a stable place of residence
• refusing to participate in the program ineligible.

Related Conditions & MeSH terms

• Cardiac Failure
• Heart Failure
• Patient Empowerment

Intervention

Device:
• Satelia®Cardio
Use of a remote patient monitoring system by NP Medical.

Other:
• Conventional care
No use of RPM solutions for follow-up

Locations

Country	Name	City	State
France	NP Medical	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Satelia

Country where clinical trial is conducted

France, 

References & Publications (3)

Creton S, Saadi M, Monfort H, Yaghobian S, Pages N, Nisse-Durgeat S, Diebold B. The Clinical Impact and Good Practices of Remote Patient Monitoring for Chronic Heart Failure: A French Case Report. Patient Prefer Adherence. 2024 Jan 16;18:131-135. doi: 10.2147/PPA.S445638. eCollection 2024. — View Citation

Jourdain P, Pages N, Amara W, Maribas P, Lafitte S, Lemieux H, Barritault F, Seronde MF, Labarre JP, Chaouky H, Bedel C, Betito L, Nisse-Durgeat S, Picard F. Perceptions and satisfaction of patients with chronic heart failure when using a remote monitoring web application named Satelia(R) Cardio. Ann Cardiol Angeiol (Paris). 2023 Jun;72(3):101606. doi: 10.1016/j.ancard.2023.101606. Epub 2023 May 25. French. — View Citation

Pages N, Picard F, Barritault F, Amara W, Lafitte S, Maribas P, Abassade P, Labarre JP, Boulestreau R, Chaouky H, Abdennadher M, Lemieux H, Lasserre R, Bedel C, Betito L, Nisse-Durgeat S, Diebold B. Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia(R) Cardio). Digit Health. 2022 Aug 22;8:20552076221116774. doi: 10.1177/20552076221116774. eCollection 2022 Jan-Dec. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of All Causes Deaths	Number of deaths for any cause	August 2018 to December 2021
Secondary	Number of unplanned heart failure Hospitalization	Number of unplanned hospitalization for heart failure	August 2018 to December 2021
Secondary	Number of All Causes Deaths in elderly patients	Number of deaths for any cause in the elderly population	August 2018 to December 2021
Secondary	Number of unplanned hospitalization for heart failure in elderly patients	Number of unplanned hospitalization for heart failure in elderly patients	August 2018 to December 2021

External Links

•   Satelia website
•   TELESAT study from the data hub