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

NCT ID: NCT06400927

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-07

Study Completion Date

2027-09-13

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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VA-guided arm

Group Type EXPERIMENTAL

HF-guided VA

Intervention Type OTHER

VA guided recommendation

Standard-of-care arm

Group Type PLACEBO_COMPARATOR

Standard-of-care

Intervention Type OTHER

Standard-of-care

Interventions

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HF-guided VA

VA guided recommendation

Intervention Type OTHER

Standard-of-care

Standard-of-care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

East and North Hertfordshire NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof Diana Gorog

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diana A Gorog, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

East and North Hertfordshire NHS Trust

Locations

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East and North Hertfordshire NHS Trust

Stevenage, Hertfordshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Joshua H Leader, MBChB, BSc

Role: CONTACT

07376188768

Diana A Gorog, MD, PhD

Role: CONTACT

01707247512

Facility Contacts

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Diana A Gorog

Role: primary

+44(0)1707 247512

Other Identifiers

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RD2024-10

Identifier Type: -

Identifier Source: org_study_id

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