Can remote monitoring ease heart failure care? new study aims to find out
NCT ID NCT07440472
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether a remote monitoring model called RAPHAEL can work for people with heart failure who may need palliative care. About 90 adults will use a digital questionnaire for 4 weeks to report symptoms and needs, while their healthcare team reviews the results. The goal is to see if this approach is feasible and acceptable, not to test a new drug or device.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could show that remote monitoring of symptoms and palliative care needs is practical for heart failure patients, potentially improving care delivery.
- What could go wrong
- This is a small feasibility study with only 90 participants and no experimental treatment, so results may not apply broadly or lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites in 9 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
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Linkopings Universitet
Linköping, Sweden
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Universitaetsklinikum Aachen
Aachen, Germany
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Universitat Internacional de Catalunya
Barcelona, Spain
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Universiteit Maastricht
Maastricht, Netherlands
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University College London
London, United Kingdom
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Università Degli Studi Di Brescia
Brescia, Italy
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Uniwersytet Medyczny Im Piastow Slaskich We Wroclawiu
Wroclaw, Poland
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Vilniaus Universitetas
Vilnius, Lithuania
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- Can a smartphone app keep heart failure patients out of the hospital?
- Can better training get doctors to talk about what matters most to dying veterans?