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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: HF-guided VA; Other: Standard-of-care

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua H Leader, MBChB, BSc; Phone Number: 07376188768; Email: joshua.leader@nhs.net
• Study Contact Backup: Name: Diana A Gorog, MD, PhD; Phone Number: 01707247512; Email: d.gorog@imperial.ac.uk

Study Locations

• United Kingdom
  • Hertfordshire
    • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
      • Recruiting
      • East and North Hertfordshire NHS Trust
      • Contact: Diana A Gorog; Phone Number: +44(0)1707 247512; Email: d.gorog@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VA-guided arm	Other: HF-guided VA; VA guided recommendation
Placebo Comparator: Standard-of-care arm	Other: Standard-of-care; Standard-of-care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the intervention to users (participants)	This will be assessed utilising an adapted 'acceptability of intervention measure' (AIM)	12 weeks

Collaborators and Investigators

• Sponsor: East and North Hertfordshire NHS Trust
• Collaborators: Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy
• Investigators: Principal Investigator: Diana A Gorog, MD, PhD, East and North Hertfordshire NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): June 13, 2027
• Study Completion (Estimated): September 13, 2027

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RD2024-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No