RecruitingRecruiting
Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure
NCT06400927 · East and North Hertfordshire NHS Trust
In plain English
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Official title
Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure: A Randomized Controlled Pilot Study: ASSIST-HF SIRIO
About this study
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
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
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-05-07
Estimated completion: 2027-09-13
Last updated: 2024-07-29
Interventions
Other: HF-guided VAOther: Standard-of-care
Primary outcomes
- • Acceptability of the intervention to users (participants) (12 weeks)
Sponsor
East and North Hertfordshire NHS Trust · other_gov
With: Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy
Contacts & investigators
ContactJoshua H Leader, MBChB, BSc · contact · joshua.leader@nhs.net · 07376188768
ContactDiana A Gorog, MD, PhD · contact · d.gorog@imperial.ac.uk · 01707247512
InvestigatorDiana A Gorog, MD, PhD · principal_investigator, East and North Hertfordshire NHS Trust
All locations (1)
East and North Hertfordshire NHS TrustRecruiting
Stevenage, Hertfordshire, United Kingdom