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NCT07440472Not yet recruiting

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.

Source: ClinicalTrials.gov · Last updated 27 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
90 (estimated)
First submitted
19 Feb 2026
Start date
Mar 2026
Primary completion date
Jul 2026
Lead sponsor
Universitat Internacional de Catalunya
NCT number
NCT07440472

What you commit to

  • Study type: Observational
  • Planned participants: 90
  • From Mar 2026 to the primary completion date, Jul 2026
  • 9 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • severe cognitive impairment or language disorders as determined by the attending healthcare professional based on clinical judgment and medical record review.
  • Cognitive impairment or language disorders determined by the attending healthcare professional.

Other

  • Acute events leading to multiple outpatient visits not related to the HF diagnosis.
  • simultaneous participation in another study.
  • inability to read and write in the language in which the study is conducted.
    • Primary caregivers:
  • inability to read and write in the language in which the study is conducted.
    • Health care professionals: a) Inability to read and write fluently in the language(s) required for the study site and for using the digital questionnaire.

Who the study is looking for

  • Patients
  • Adult patients (≥18 years) with the main diagnosis of HF according to current guidelines (20), living at home; recruitment will be stratified by sex and limited to 60-70% for either sex.
  • Screen positive for one of the three clinical "sensitizing" questions, intended to identify potential palliative care (PC) needs:
    • 'Would I be surprised if this patient were to die within one year?'
    • A "No" response indicates possible palliative care needs. 'Has this patient experienced 'escalating care events' at least twice in the past year, including i) unscheduled hospitalizations for HF, ii) emergency department visits for HF, iii) visits to out-of-hours primary care services for HF, and/or iv) other similar escalating care events?'
    • A "Yes" response indicates possible PC needs. 'Is this patient experiencing persistent or worsening multidimensional symptoms (e.g., physical, psychological, social, or spiritual concerns) despite optimal HF treatment, such that a palliative assessment is indicated (upon discretion of the treating physician or nurse)?'
    • A "Yes" response indicates possible PC needs.
  • patient's or informal caregiver's ability to use technology (e.g., having internet access, owning a smartphone or tablet, or having someone available who can assist them).
  • capacity to provide informed consent.
    • Primary Caregiver:
  • Informal caregiver who is present with the patient during the implementation of the intervention
  • ≥18 years
  • capacity to provide consent.
    • Healthcare professionals: Two professionals identified by the consortium in each site, willing to be trained in the intervention to perform the feasibility study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire Vaudois
Coordinator of this site? Confirm its status
LausanneSwitzerlandUnknown status
Universitaetsklinikum Aachen
Coordinator of this site? Confirm its status
AachenGermanyUnknown status
Universitat Internacional de Catalunya
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
University College London
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Università degli Studi di Brescia
Coordinator of this site? Confirm its status
BresciaItalyUnknown status
Vilniaus Universitetas
Coordinator of this site? Confirm its status
VilniusLithuaniaUnknown status
Universiteit Maastricht
Coordinator of this site? Confirm its status
MaastrichtNetherlandsUnknown status
Uniwersytet Medyczny Im Piastow Slaskich We Wroclawiu
Coordinator of this site? Confirm its status
WroclawPolandUnknown status
Linköpings Universitet
Coordinator of this site? Confirm its status
LinköpingSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.