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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06312501
Other study ID # 2021-0020 TELESAT
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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