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NCT Number: NCT06400927

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

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.

Recruiting

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East and North Hertfordshire NHS Trust

Stevenage, Hertfordshire, SG1 4AB, United Kingdom

Location status: Recruiting

Location contact

Diana A Gorog

CONTACT

[email protected]

+44(0)1707 247512

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HF-guided VA

Other

VA guided recommendation

Standard-of-care

Other

Standard-of-care

Primary outcomes

  1. Acceptability of the intervention to users (participants)

    Time frame: 12 weeks

    This will be assessed utilising an adapted 'acceptability of intervention measure' (AIM)

Study contacts

Contact information is provided by the study sponsor or research team.

Diana A Gorog, MD, PhD

CONTACT

[email protected]

01707247512

Joshua H Leader, MBChB, BSc

CONTACT

[email protected]

07376188768

Sponsors and collaborators

Lead sponsor

East and North Hertfordshire NHS Trust

Other Gov

Collaborators

  • Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 6, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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