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Recruiting NCT06400927

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

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HF-guided VA, Standard-of-care.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other HF-guided VA
    VA guided recommendation
  • Other Standard-of-care
    Standard-of-care

Primary outcome measures

  • Acceptability of the intervention to users (participants) [Time frame: 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • East and North Hertfordshire NHS Trust — Stevenage

Identifiers

NCT: NCT06400927 · RD2024-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗