Heart FailureNCT06400927
Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure
A study testing HF-guided VA and Standard-of-care in people with Heart Failure, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HF-guided VA and Standard-of-care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 May 2024to 13 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Newly diagnosed HF with New York Heart Association class II-III symptoms at discharge
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, SG1 4AB
Diana A Gorog, +44(0)1707 247512, d.gorog@nhs.net
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- HF-guided VA, Standard-of-care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF-guided VAOther
VA guided recommendation
Standard-of-careOther
Standard-of-care
| Study group | Role | What they receive |
|---|---|---|
| VA-guided arm | Experimental | Not described Receives: Other: HF-guided VA |
| Standard-of-care arm | Placebo comparator | Not described Receives: Other: Standard-of-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention to users (participants)
This will be assessed utilising an adapted 'acceptability of intervention measure' (AIM)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start7 May 2024
- Primary completion13 Jun 2027 (estimated)
- Study completion13 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy
- Responsible party
- Principal investigator, Prof Diana Gorog, East and North Hertfordshire NHS Trust
- Investigators
- Diana A Gorog, MD, PhD, Principal investigator, East and North Hertfordshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400927
- Sponsor's protocol ID
- RD2024-10
- Status last verified
- Jul 2024
- First submitted
- 29 Apr 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure: A Randomized Controlled Pilot Study: ASSIST-HF SIRIO
- ClinicalTrials.gov ID
- NCT06400927
- Acronym / sponsor ID
- RD2024-10
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy
- Study start
- 7 May 2024 (actual)
- Primary completion
- 13 Jun 2027 (estimated)
- Study completion
- 13 Sep 2027 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA-guided arm | Experimental | Other: HF-guided VA |
| Standard-of-care arm | Placebo comparator | Other: Standard-of-care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Newly diagnosed HF with New York Heart Association class II-III symptoms at discharge
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HF-guided VAVA guided recommendation | Other | VA-guided arm |
| Standard-of-careStandard-of-care | Other | Standard-of-care arm |
Primary outcome
Acceptability of the intervention to users (participants)
Time frame: 12 weeks
This will be assessed utilising an adapted 'acceptability of intervention measure' (AIM)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana A Gorog, MD, PhD principal investigator
East and North Hertfordshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HF-guided VA and Standard-of-care in people with Heart Failure, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua H Leader, MBChB, BSc (07376188768, joshua.leader@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention to users (participants) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.