Remote monitoring with Caaring for people with reduced ejection fraction heart failure
Determination of the Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction Using Caaring® Software
Test whether using the Caaring smartphone app for remote monitoring helps people with reduced ejection fraction heart failure avoid hospital readmission over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Persei Vivarium Academic / other |
| Locations | 2 sites (Ferrol, A Coruña and 1 other locations) |
| Trial ID | NCT06920160 on ClinicalTrials.gov |
What this trial studies
This randomized, multicenter, non-inferiority trial compares remote telemonitoring via the Caaring® software to routine prospective follow-up in patients with heart failure and reduced ejection fraction. Participants are randomly assigned to the Caaring telemonitoring arm or a prospective control arm, with clinical data collected for 12 weeks after inclusion. The Caaring platform supports patient self-management and captures remote symptom and device-reported data through the patient’s smartphone to trigger clinical alerts. The primary comparison focuses on rates of rehospitalization or clinical re-entries during the follow-up period.
Who should consider this trial
Good fit: Adults (≥18) with heart failure and reduced ejection fraction (EF ≤40%) recently discharged after an acute heart failure episode or in follow-up who routinely use a smartphone and can give informed consent.
Not a fit: Patients who cannot use a smartphone, have cognitive or significant sensory impairments without a legal representative, or who cannot complete follow-up due to relocation are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the app could reduce hospital readmissions and improve self-management for people with reduced ejection fraction heart failure.
How similar studies have performed: Previous telemonitoring and remote-monitoring trials in heart failure have shown mixed but sometimes positive results on readmissions and self-care, while Caaring® itself appears novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or older * Patients diagnosed with heart failure with reduced ejection fraction (EFS40%) * Patients discharged after an episode of acute heart failure and/or patients who are being followed up after being admitted for heart failure. * Patients who extensively use a smartphone. * lnformed Consent is obtained from the patient Exclusion Criteria: * Patients with cognitive ar sensory difficulties or with insufficient command of Spanish who, in the opinion of the investigator, makes it difficult to understand the questions ar the scales, as long as they do not have a legally authorized representative capable of participating in the study. * Transient patients in whom it may be anticipated that follow-up will not be completed due to a change of residence. * Patients Who are participating at the time of recruitment in any other clinical trial. Participation in observational studies will not be an exclusion criteria. * Patients whose main diagnosis is a poorly controlled mental disorders ar other medical illness. * Patients with terminal illness and/or in palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care). * lnstitutionalized patients * Patients who are pregnant ar breastfeeding. * Patients whose inclusion is not considered advisable by the investigator's assessment due to they are under specific follow-up in other hospital units (hemodialysis, transplants, etc.) that require mandatory hospital attendance less frequently than once every two months.
Where this trial is running
Ferrol, A Coruña and 1 other locations
- Complejo Hospitalario Universitario de Ferrol — Ferrol, A Coruña, Spain (Not_yet_recruiting)
- Hospital Universitario de Son Llatzer — Palma de Mallorca, Balearic Islands, Spain (Recruiting)
Study contacts
- Study coordinator: Roberto Bravo
- Email: roberto.bravo@perseivivarium.com
- Phone: +34 915004013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.