Heart FailureNCT07626853
Digital Literacy of Chronic Heart Failure Patients
An observational study of Heart Failure and Chronic Disease, run by Satelia at 1 site in France.
Trial summary
A retrospective cohort study was conducted using a web application (Satelia®Cardio by NP Medical) for the management of chronic heart failure. Patients were categorized according to digital literacy (digitally literate versus poor digital literacy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Chronic Disease
- How many people
- 26,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were categorized according to their digital literacy as either being digital literate or having poor digital literacy. Being digitally literate referred to those that could enter their data into the system themselves. Patients with poor digital literacy were identified as those requiring the assistance from another person which may have been a family caregiver, a nurse visiting for a purpose other than CHF management, or an RPM nurse by phone where the aforementioned options were unavailable.
Who may be able to join
- Age 18 years or older
- Diagnosis of chronic heart failure
- Enrolment in the national heart failure remote monitoring program between September 3, 2018, and April 21, 2026
- Availability of baseline clinical data including digital literacy status
Who cannot join
- Missing baseline information on digital literacy status
- Missing follow-up data for survival status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Literacy of Patients With Chronic Heart Failure in France: Results of a National-scale Retrospective Study
A retrospective cohort study was conducted using a web application (Satelia®Cardio by NP Medical) for the management of chronic heart failure. Patients were categorized according to digital literacy (digitally literate versus poor digital literacy).
Read the detailed description
A nationwide retrospective study was conducted from August 2018 and December 2025 in +300 centers in France. Data was automatically extracted from the web application and included baseline characteristics, comorbidities, RPM status, heart failure-related hospitalizations and mortality.
- Conditions
- Heart Failure, Chronic Disease
- Keywords
- remote patient monitoring, chronic heart failure, digital literacy, telehealth, web application, chronic disease management
- Medical subject headings
- Heart Failure, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Digitally literate | Patients who used remote patient monitoring for follow-ups and the management of chronic heart failure. | |
| Poor digital literacy | Patients with poor digital literacy were identified as those requiring the assistance from another person which may have been a family caregiver, a nurse visiting for a purpose other than CHF management, or an RPM nurse by phone where the aforementioned options were unavailable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure related hospitalizations
The primary outcome of this study is the number of heart failure related hospitalizations while a patient is using RPM to follow-up their condition (heart failure).
Measured: 6 years
Mortality rate
Another primary outcome of this study is the mortality rate of patients using RPM for CHF management.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Aug 2018
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 26,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satelia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Pages, MD, Study director, NP Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626853
- Sponsor's protocol ID
- S05100124
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delmas C, Simoni AS, Goeminne C, Boignard A, Martin AC, Vanhuyse F, Flecher E, Nafeh-Bizet C, Itier R, Pages N, Nisse-Durgeat S, Battistella P, Nubret-le-Coniat K. Follow-Up of Left-Ventricular Assist Device Patients With Telemonitoring: A National Retrospective Multicentric Study on the Satelia LVAD Web Application. Artif Organs. 2026 Feb;50(2):250-258. doi: 10.1111/aor.70038. Epub 2025 Nov 8.
PubMed 41204797Girerd N, Barbet V, Seronde MF, Benchimol H, Jagu A, Tartiere JM, Hanon O, Picard F, Lafitte S, Lemaitre M, Pages N, Nisse-Durgeat S, Jourdain P. Association of a remote monitoring programme with all-cause mortality and hospitalizations in patients with heart failure: National-scale, real-world evidence from a 3-year propensity score analysis of the TELESAT-HF study. Eur J Heart Fail. 2025 Sep;27(9):1658-1669. doi: 10.1002/ejhf.3563. Epub 2025 Jan 14.
PubMed 39807086Kurland RJ, Ngo FQ. Effect of induced field inhomogeneity on transverse proton NMR relaxation in tissue water and model systems. Magn Reson Med. 1986 Jun;3(3):425-31. doi: 10.1002/mrm.1910030307.
PubMed 3724421Pages 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.
PubMed 36034602
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Literacy of Patients With Chronic Heart Failure in France: Results of a National-scale Retrospective Study
- ClinicalTrials.gov ID
- NCT07626853
- Acronym / sponsor ID
- S05100124
- Conditions
- Heart Failure, Chronic Disease
- Keywords
- remote patient monitoring, chronic heart failure, digital literacy, telehealth, web application, chronic disease management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,000 participants (actual)
- Lead sponsor
- SateliaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective cohort study was conducted using a web application (Satelia®Cardio by NP Medical) for the management of chronic heart failure. Patients were categorized according to digital literacy (digitally literate versus poor digital literacy).
Detailed description
A nationwide retrospective study was conducted from August 2018 and December 2025 in +300 centers in France. Data was automatically extracted from the web application and included baseline characteristics, comorbidities, RPM status, heart failure-related hospitalizations and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digitally literate | – | –Patients who used remote patient monitoring for follow-ups and the management of chronic heart failure. |
| Poor digital literacy | – | –Patients with poor digital literacy were identified as those requiring the assistance from another person which may have been a family caregiver, a nurse visiting for a purpose other than CHF management, or an RPM nurse by phone where the aforementioned options were unavailable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were categorized according to their digital literacy as either being digital literate or having poor digital literacy. Being digitally literate referred to those that could enter their data into the system themselves. Patients with poor digital literacy were identified as those requiring the assistance from another person which may have been a family caregiver, a nurse visiting for a purpose other than CHF management, or an RPM nurse by phone where the aforementioned options were unavailable.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Diagnosis of chronic heart failure
- Enrolment in the national heart failure remote monitoring program between September 3, 2018, and April 21, 2026
- Availability of baseline clinical data including digital literacy status
Key exclusion criteria (2 listed)
- Missing baseline information on digital literacy status
- Missing follow-up data for survival status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart failure related hospitalizations
Time frame: 6 years
The primary outcome of this study is the number of heart failure related hospitalizations while a patient is using RPM to follow-up their condition (heart failure).
Mortality rate
Time frame: 6 years
Another primary outcome of this study is the mortality rate of patients using RPM for CHF management.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 41204797Delmas C, Simoni AS, Goeminne C, Boignard A, Martin AC, Vanhuyse F, Flecher E, Nafeh-Bizet C, Itier R, Pages N, Nisse-Durgeat S, Battistella P, Nubret-le-Coniat K. Follow-Up of Left-Ventricular Assist Device Patients With Telemonitoring: A National Retrospective Multicentric Study on the Satelia LVAD Web Application. Artif Organs. 2026 Feb;50(2):250-258. doi: 10.1111/aor.70038. Epub 2025 Nov 8.
- Background: PubMed 39807086Girerd N, Barbet V, Seronde MF, Benchimol H, Jagu A, Tartiere JM, Hanon O, Picard F, Lafitte S, Lemaitre M, Pages N, Nisse-Durgeat S, Jourdain P. Association of a remote monitoring programme with all-cause mortality and hospitalizations in patients with heart failure: National-scale, real-world evidence from a 3-year propensity score analysis of the TELESAT-HF study. Eur J Heart Fail. 2025 Sep;27(9):1658-1669. doi: 10.1002/ejhf.3563. Epub 2025 Jan 14.
- Background: PubMed 3724421Kurland RJ, Ngo FQ. Effect of induced field inhomogeneity on transverse proton NMR relaxation in tissue water and model systems. Magn Reson Med. 1986 Jun;3(3):425-31. doi: 10.1002/mrm.1910030307.
- Background: PubMed 36034602Pages 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.
- RPM medical device providers websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Pages, MD study director
NP Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Chronic Disease, run by Satelia at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure related hospitalizations (time frame: 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07626853, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.