Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEast and North Hertfordshire NHS Trust
About this trial
The aim of this pilot randomized study is to examine whether integrating the SIRIO-HF virtual assistant (VA) into the outpatient management of participants recently discharged from hospital with a new diagnosis of heart failure (HF), may reduce the need for regular medical assessment and the healthcare burden, reduce variability in healthcare, and meet with participant satisfaction, without compromising participant safety and overall care quality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Newly diagnosed HF with New York Heart Association class II-III symptoms at discharge
Disqualifiers
Known prior history of HF
Severe comorbidities that could affect protocol adherence, in the opinion of the investigator
Alternative diagnosis for symptoms such as chronic obstructive pulmonary disease
Dementia or other cognitive impairment
Trial design
Design model
Single group
Treatments tested in this trial
HF-guided VA
Other interventionVA guided recommendation
Standard-of-care
Other interventionStandard-of-care
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: VA-guided armExperimental treatment 1 intervention
Group B: Standard-of-care armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability of the intervention to users (participants)
This will be assessed utilising an adapted 'acceptability of intervention measure' (AIM)
Time frame
12 weeksSponsors and contacts
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East and North Hertfordshire NHS Trust
Lead sponsor
Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy
Collaborator
Source ClinicalTrials.gov