NCT07440472

A Study on Remote Health Support for Patients With Heart Failure.

Feasibility of Implementing a Remote Monitoring Palliative Care Model for Patients With Heart Failure.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Universitat Internacional de Catalunya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The RAPHAEL study (Work Package 4) is a multicenter, prospective observational feasibility study conducted across participating European clinical sites. The objective is to evaluate the implementation of a structured remote monitoring palliative care model integrated into routine outpatient heart failure care. Patients with a confirmed diagnosis of heart failure who present with worsening symptoms and/or indicators of palliative care needs will be invited to participate. Participants will complete a structured digital questionnaire designed to identify symptom burden, psychosocial concerns, and potential unmet palliative care needs. The questionnaire is administered once during a 4-week observation period. Healthcare professionals trained in the RAPHAEL model will review questionnaire responses and may initiate follow-up contact or clinical actions according to standard clinical judgment and existing care pathways. The study does not mandate changes to pharmacological treatment, and all medical decisions remain under routine clinical practice. The primary objective is to assess feasibility and implementation outcomes, including recruitment capability, participation rates, acceptability, usability, perceived burden for patients and professionals, fidelity to the intervention components, required resources, adaptation processes, and demand. Secondary objectives include descriptive assessment of symptom burden and identified palliative care needs. The study is classified as an observational prospective study according to ethics committee approval. No randomization, experimental interventions, or investigational medicinal products are involved.

Conditions

• Heart Failure

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

9 sites across 9 countries: Germany, Italy, Lithuania, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom