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Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure

Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure: A Randomized Controlled Pilot Study: ASSIST-HF SIRIO

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06400927
Enrollment
60
Registered
2024-05-06
Start date
2024-05-07
Completion date
2027-09-13
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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.

Interventions

OTHERHF-guided VA

VA guided recommendation

OTHERStandard-of-care

Standard-of-care

Sponsors

Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy
CollaboratorUNKNOWN
East and North Hertfordshire NHS Trust
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Newly diagnosed HF with New York Heart Association class II-III symptoms at discharge

Exclusion criteria

* 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 * Currently involved in another interventional clinical trial

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of the intervention to users (participants)12 weeksThis will be assessed utilising an adapted 'acceptability of intervention measure' (AIM)

Countries

United Kingdom

Contacts

Primary ContactJoshua H Leader, MBChB, BSc
joshua.leader@nhs.net07376188768
Backup ContactDiana A Gorog, MD, PhD
d.gorog@imperial.ac.uk01707247512

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026