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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure

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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Cristina Monforte, Phd; Phone Number: +34652428214; Email: cmonforte@uic.es

Study Locations

• Germany
  • Aachen, Germany
    • Universitaetsklinikum Aachen
• Italy
  • Brescia, Italy
    • Università degli Studi di Brescia
• Lithuania
  • Vilnius, Lithuania
    • Vilniaus Universitetas
• Netherlands
  • Maastricht, Netherlands
    • Universiteit Maastricht
• Poland
  • Wroclaw, Poland
    • Uniwersytet Medyczny Im Piastow Slaskich We Wroclawiu
• Spain
  • Barcelona, Spain
    • Universitat Internacional de Catalunya
• Sweden
  • Linköping, Sweden
    • Linköpings Universitet
• Switzerland
  • Lausanne, Switzerland
    • Centre Hospitalier Universitaire Vaudois
• United Kingdom
  • London, United Kingdom
    • University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

Patients

1. 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.

2. 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.
3. 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).
4. capacity to provide informed consent.

Primary Caregiver:

1. Informal caregiver who is present with the patient during the implementation of the intervention
2. ≥18 years
3. 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.

Exclusion Criteria:

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

Primary caregivers:

1. Cognitive impairment or language disorders determined by the attending healthcare professional.
2. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the RAPHAEL Model	Patient-reported acceptability of the digital questionnaire and follow-up process assessed using structured evaluation questions at the end of the 4-week observation period. It will be evaluated using a Likert scale (0 - Completely inappropriate, 1 - Rather inappropriate, 2 - Rather appropriate, 3 - Completely appropriate). A 4-point scale was selected to minimize respondent burden and to facilitate cross-country comparability, while still capturing meaningful differences in perception. Criterion: ≥ 75% of patients score ≥ 2.	4 weeks
Usability of the Digital Questionnaire	Participant-reported usability of the structured digital questionnaire, including ease of use and clarity of questions, assessed at the end of the observation period. It will be evaluated using a dichotomous answer (yes/no). Criterion: ≥ 75% of patients consider the intervention to be easy to use.	4 weeks
Perceived Burden	Patient-reported perceived burden associated with completing the questionnaire and participating in the study procedures. This will be measured using a Likert scale (0 - no burden, 1 - Light burden, 2 - Moderate burden, 3 - Heavy burden). Criterion: ≥ 75% of participants rate the burden as ≤ 1.	4 weeks
Fidelity to the RAPHAEL Model	Proportion of cases in which healthcare professionals reviewed questionnaire responses and documented follow-up actions according to the study framework. Criterion: ≥ 80% of the patients complete the 4 steps of the RAPHAEL intervention during their enrollment.	4 weeks
Healthcare Professional Adoption	Assessment of healthcare professional engagement with and adoption of the RAPHAEL model during the study period. Criterion: all participating healthcare professionals complete the final assignment of the online training.	4 weeks

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Collaborators: University College London Hospitals; Maastricht University Medical Center; UMC Utrecht; University of Leeds; Linkoeping University; Centre Hospitalier Universitaire Vaudois; Wroclaw Medical University; Althaia Xarxa Assistencial Universitària de Manresa; Università degli Studi di Brescia; University Hospital, Aachen; Vilnius University; University of Vic - Central University of Catalonia; European Association for Palliative Care (EAPC); University of Humanistic Studies; IRIS-CC

Publications and helpful links

General Publications

• Lormans T,de Graaf E,van der Baan F,Leget C,Teunissen S
• 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
• Grice-Jackson T,Jaarsma P,Friedrichsen M,Wallin MI,De Graaf E,Strömberg A,Jaarsma T

Helpful Links

• Raphael website
• Raphel LinkedIn official profile

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Palliative Care; Remote Monitoring; Feasibility Study; Outpatient Care; Symptom Assessment; Mix Methods; Multinational european study
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: RAPHAEL-WP4-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No