Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started May 2024
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2024
CompletedFirst Posted
Study publicly available on registry
May 6, 2024
CompletedStudy Start
First participant enrolled
May 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 13, 2027
July 29, 2024
July 1, 2024
3.1 years
April 29, 2024
July 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Acceptability of the intervention to users (participants)
This will be assessed utilising an adapted 'acceptability of intervention measure' (AIM)
12 weeks
Study Arms (2)
VA-guided arm
EXPERIMENTALStandard-of-care arm
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Newly diagnosed HF with New York Heart Association class II-III symptoms at discharge
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, SG1 4AB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana A Gorog, MD, PhD
East and North Hertfordshire NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 29, 2024
First Posted
May 6, 2024
Study Start
May 7, 2024
Primary Completion (Estimated)
June 13, 2027
Study Completion (Estimated)
September 13, 2027
Last Updated
July 29, 2024
Record last verified: 2024-07