A Study on Remote Health Support for Patients With Heart Failure.
ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitat Internacional de Catalunya
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 1 trial groupGroup A: Adults with heart failure and palliative care needs receiving routine outpatient care.
Trial outcomes
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%.
Time frame
4 weeksSecondary outcomes
1
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.
Time frame
4 weeks2
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.
Time frame
4 weeks3
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.
Time frame
4 weeks4
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.
Time frame
4 weeksSponsors and contacts
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Universitat Internacional de Catalunya
Lead sponsor
Università degli Studi di Brescia
Collaborator
Linkoeping University
Collaborator
University College London Hospitals
Collaborator
European Association for Palliative Care (EAPC)
Collaborator
Centre Hospitalier Universitaire Vaudois
Collaborator
University of Leeds
Collaborator
Maastricht University Medical Center
Collaborator
University of Humanistic Studies
Collaborator
Althaia Xarxa Assistencial Universitària de Manresa
Collaborator
IRIS-CC
Collaborator
University of Vic - Central University of Catalonia
Collaborator
University Hospital, Aachen
Collaborator
Wroclaw Medical University
Collaborator
UMC Utrecht
Collaborator
Vilnius University
Collaborator
Source ClinicalTrials.gov
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