Heart FailureRAPHAELNCT07440472
A Study on Remote Health Support for Patients With Heart Failure.
An observational study of Heart Failure, run by Universitat Internacional de Catalunya at 9 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 90 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Mar 2026to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)?'
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 9 countries
About this study
Official title: 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.
Read the 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
- Keywords
- Palliative Care, Remote Monitoring, Feasibility Study, Symptom Assessment, Outpatient Care, Mix Methods, Multinational european study
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with heart failure and palliative care needs receiving routine outpatient care. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 4 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Brescia, Linkoeping University, University College London Hospitals, European Association for Palliative Care, Centre Hospitalier Universitaire Vaudois, University of Leeds, Maastricht University Medical Center, University of Humanistic Studies, Althaia Xarxa Assistencial Universitària de Manresa, IRIS-CC, University of Vic - Central University of Catalonia, University Hospital, Aachen, Wroclaw Medical University, UMC Utrecht, Vilnius University
- Responsible party
- Principal investigator, Cristina Monforte Royo, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440472
- Sponsor's protocol ID
- RAPHAEL-WP4-2026
- Acronym
- RAPHAEL
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40017379Pastrana 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.
PubMed 41017534Grice-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.
PubMed 41134436
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing a Remote Monitoring Palliative Care Model for Patients With Heart Failure.
- ClinicalTrials.gov ID
- NCT07440472
- Acronym / sponsor ID
- RAPHAEL / RAPHAEL-WP4-2026
- Conditions
- Heart Failure
- Keywords
- Palliative Care, Remote Monitoring, Feasibility Study, Symptom Assessment, Outpatient Care, Mix Methods, Multinational european study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Università degli Studi di Brescia, Linkoeping University, University College London Hospitals, European Association for Palliative Care, Centre Hospitalier Universitaire Vaudois, University of Leeds, Maastricht University Medical Center, University of Humanistic Studies, Althaia Xarxa Assistencial Universitària de Manresa, IRIS-CC, University of Vic - Central University of Catalonia, University Hospital, Aachen, Wroclaw Medical University, UMC Utrecht, Vilnius University
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with heart failure and palliative care needs receiving routine outpatient care. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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?'
- 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).
Key exclusion criteria (8 listed)
- 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.
- Cognitive impairment or language disorders determined by the attending healthcare professional.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participation Rate Among Eligible Patients
Time frame: 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%.
5 secondary outcomes
Acceptability of the RAPHAEL Model
Time frame: 4 weeks
Usability of the Digital Questionnaire
Time frame: 4 weeks
Perceived Burden
Time frame: 4 weeks
Fidelity to the RAPHAEL Model
Time frame: 4 weeks
Healthcare Professional Adoption
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 40017379Lormans 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.
- Background: PubMed 41017534Pastrana 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.
- Background: PubMed 41134436Grice-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.
- Raphael websiteLink provided by the sponsor.
- Raphel LinkedIn official profileLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Universitat Internacional de Catalunya at 9 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Italy, Lithuania, Netherlands, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Monforte, Phd (+34652428214, cmonforte@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation Rate Among Eligible Patients (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07440472, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.