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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
90 Participants
are grouped into 1 trial groupSponsors and collaborators
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