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

East and North Hertfordshire NHS Trust

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: HF-guided VA; Other: Standard-of-care

Study type: Interventional

Funder types: Other

Identifiers

NCT06400927

RD2024-10

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

VA-guided arm

Experimental group

Treatment:

Other: HF-guided VA

Standard-of-care arm

Placebo Comparator group

Treatment:

Other: Standard-of-care