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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
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
More Universitat Internacional de Catalunya trials in Spain
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.
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