Evaluating the Effectiveness of Remote Patient Monitoring (Satelia® Cardio) for Patients With Heart Failure (TELESAT-HF Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Satelia
- Enrollment
- 20000
- Locations
- 1
- Primary Endpoint
- Number of All Causes Deaths
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Number of All Causes Deaths
Time Frame: August 2018 to December 2021
Number of deaths for any cause
Secondary Outcomes
- Number of All Causes Deaths in elderly patients(August 2018 to December 2021)
- Number of unplanned hospitalization for heart failure in elderly patients(August 2018 to December 2021)
- Number of unplanned heart failure Hospitalization(August 2018 to December 2021)