Clinical trial NCT06312501: Remote Patient Monitoring for Patients With Heart Failure in France
Official title: Evaluating the Effectiveness of Remote Patient Monitoring (Satelia® Cardio) for Patients With Heart Failure (TELESAT-HF Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Patient Empowerment
Cardiac Failure
Keywords: Remote patient monitoring
Heart failure
Cardiac decompensation
Telehealth
Lead sponsor: Satelia
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20,000 patients with heart failure across France.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of All Causes Deaths
timeFrame: August 2018 to December 2021
Secondary outcomes:
measure: Number of unplanned heart failure Hospitalization
timeFrame: August 2018 to December 2021
measure: Number of All Causes Deaths in elderly patients
timeFrame: August 2018 to December 2021
measure: Number of unplanned hospitalization for heart failure in elderly patients
timeFrame: August 2018 to December 2021
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: NP Medical
Study officials:
affiliation: NP Medical
name: Nicolas Pages, MD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.