NCT07440472

Brief 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.

Trial Health

70
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
9 countries

9 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

February 19, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 19, 2026

Last Update Submit

February 25, 2026

Conditions

Heart Failure

Keywords

Palliative CareRemote MonitoringFeasibility StudySymptom AssessmentOutpatient CareMix MethodsMultinational european study

Outcome Measures

Primary Outcomes (1)

  • Participation Rate Among Eligible Patients

    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%.

    4 weeks

Secondary Outcomes (5)

  • Acceptability of the RAPHAEL Model

    4 weeks

  • Usability of the Digital Questionnaire

    4 weeks

  • Perceived Burden

    4 weeks

  • Fidelity to the RAPHAEL Model

    4 weeks

  • Healthcare Professional Adoption

    4 weeks

Study Arms (1)

Adults with heart failure and palliative care needs receiving routine outpatient care.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with a confirmed diagnosis of heart failure receiving outpatient care at Hospital de Granollers who are identified as having worsening symptoms and/or palliative care needs and are eligible to participate in the RAPHAEL feasibility study.

You may qualify if:

  • 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.

You may not qualify if:

  • Acute events leading to multiple outpatient visits not related to the HF diagnosis.
  • severe cognitive impairment or language disorders as determined by the attending healthcare professional based on clinical judgment and medical record review.
  • simultaneous participation in another study.
  • inability to read and write in the language in which the study is conducted.
  • Primary caregivers:
  • Cognitive impairment or language disorders determined by the attending healthcare professional.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universitaetsklinikum Aachen

Aachen, Germany

Location

Università Degli Studi Di Brescia

Brescia, Italy

Location

Vilniaus Universitetas

Vilnius, Lithuania

Location

Universiteit Maastricht

Maastricht, Netherlands

Location

Uniwersytet Medyczny Im Piastow Slaskich We Wroclawiu

Wroclaw, Poland

Location

Universitat Internacional de Catalunya

Barcelona, Spain

Location

Linkopings Universitet

Linköping, Sweden

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

University College London

London, United Kingdom

Location

Related Publications (3)

  • Lormans T, de Graaf E, van der Baan F, Leget C, Teunissen S. Validating the socio-spiritual items of the Utrecht Symptom Diary-4 Dimensional: Content and construct validity. Palliat Med. 2025 May;39(5):622-634. doi: 10.1177/02692163251321692. Epub 2025 Feb 28.

    PMID: 40017379BACKGROUND

  • Pastrana T, Grant M, Andrade PH, Marelli D, Witte K, Geersing GJ, Ripamonti C, Rolke R, Metra M, Pagnesi M, De Graaf E, Chelazzi C; RAPHAEL consortium. Mapping of current practices of palliative care for patients with heart failure throughout Europe: A scoping review. ESC Heart Fail. 2025 Dec;12(6):4021-4032. doi: 10.1002/ehf2.15431. Epub 2025 Sep 29.

    PMID: 41017534BACKGROUND

  • Grice-Jackson T, Jaarsma P, Friedrichsen M, Wallin MI, De Graaf E, Stromberg A, Jaarsma T. Barriers and Facilitators for Implementation of Palliative Care for Patients with Heart failure - a Rapid Synthesis of Reviews. Curr Heart Fail Rep. 2025 Oct 24;22(1):31. doi: 10.1007/s11897-025-00715-y.

    PMID: 41134436BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Cristina Monforte, Phd

CONTACT

+34652428214cmonforte@uic.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)GB(1)PL(1)ES(1)CH(1)NL(1)DE(1)LI(1)SE(1)