A Study on Remote Health Support for Patients With Heart Failure.
Condition(s) studied
Study summary
This multicenter prospective observational feasibility study evaluates the implementation of the RAPHAEL model, a remote monitoring palliative care approach for patients with heart failure. The study aims to assess the feasibility, acceptability, usability, and implementation outcomes of integrating structured remote symptom monitoring and palliative care needs assessment into routine outpatient heart failure care.
Adult patients with heart failure and worsening symptoms and/or potential palliative care needs will complete a structured digital questionnaire during a 4-week follow-up period. Healthcare professionals will review reported needs and conduct follow-up contact according to usual clinical practice. No experimental drugs or devices are administered, and clinical management remains at the discretion of the treating team.
Primary outcomes focus on feasibility and implementation metrics, including participation rates, acceptability, usability, perceived burden, resource requirements, fidelity to the intervention model, training adoption, applicability, adaptation, and demand.
Eligibility
Primary outcome measure(s)
- Participation Rate Among Eligible Patients — 4 weeks
Participation will be measured as the proportion of eligible patients with heart failure who provide informed consent and enroll in the RAPHAEL intervention during the 4-week observation period. Unit of Measure: Percentage (%) Calculated as follows: Numerator: Number of eligible patients who provide written informed consent and are enrolled. Denominator: Total number of eligible patients approached for participation by healthcare professionals. The prespecified feasibility criterion for success is a participation rate greater than 60%.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Universitaetsklinikum Aachen | Aachen | Germany | |
| Università Degli Studi Di Brescia | Brescia | Italy | |
| Vilniaus Universitetas | Vilnius | Lithuania | |
| Universiteit Maastricht | Maastricht | Netherlands | |
| Uniwersytet Medyczny Im Piastow Slaskich We Wroclawiu | Wroclaw | Poland | |
| Universitat Internacional de Catalunya | Barcelona | Spain | |
| Linkopings Universitet | Linköping | Sweden | |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | |
| University College London | London | United Kingdom |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07440472 on ClinicalTrials.gov ↗ ← All trials in Italy