AI-guided AF Treatment

ConditionAtrial Fibrillation (AF)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorEast and North Hertfordshire NHS Trust

About this trial

Two-centre, prospective, randomized, open-label, controlled pilot study to examine whether integrating an artificial intelligence virtual assistant (VA), instructed with the latest international guidelines on optimal patient management into the outpatient management of patients diagnosed with atrial fibrillation (AF) in the last 6 months, is feasible, acceptable and effective in reducing the need for regular medical assessment and the healthcare burden, reduce variability, and meets with participant satisfaction, without compromising participant safety and overall care quality.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Documented diagnosis of AF within the last 6 months

Patient is at least mildly symptomatic. Presence of at least one of the symptoms like palpitation, dizziness, breathlessness, pre-syncope, and syncope with at least mild intensity

Ability to understand and comprehend the study rationale, design, and process.

Disqualifiers

Severe comorbidities (such as physical impairment, cognitive impairment, and hearing loss) that could affect protocol adherence, in the opinion of the investigator

Chronic Kidney Disease (CKD) stage 4-5 or on dialysis

Medical illness with a life expectancy of less than 1 year

Alternative potentially reversible causes of AF (such as surgery, sepsis, or thyroid dysfunction)

Trial design

Design model

Parallel

Treatments tested in this trial

virtual assistant
Other intervention
Programming codes that interpret atrial fibrillation symptoms and design management plans based on algorithms that reflect the European Society of Cardiology (ESC) 2024 guidelines and the expertise of consultant cardiologists, finally checked and approved by a cardiologist.
Standard AF care
Other intervention
AF care provided via the National Health System (NHS) standard AF care system

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Standard of CarePlacebo comparator 1 intervention

Group B: Virtual AssistantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

How acceptable is the Virtual Assistant (VA) system as assessed by Sekhon's Theoretical Framework of Acceptability (TFA) questionnaire.

The acceptability of the Virtual Assistant (VA) system will be assessed using an acceptability questionnaire adapted from the 2022 Sekhon et al. Theoretical Framework of Acceptability (TFA). The questionnaire will be completed separately by both patients and research administrators, with the resulting scores reflecting the overall acceptability of the intervention. The questionnaire employs Likert-type scales and includes the following TFA components, where the highest score shows greater acceptability in that component: Affective Attitude: 2 items (scored 0-10, where 0 = lowest acceptability and 10 = highest) Burden: 2 items (scored 0-10) Ethicality: 1 item (scored 0-5) Perceived Effectiveness: 1 item (scored 0-7) Intervention Coherence: 1 item (scored 0-5) Self-Efficacy: 2 items (scored 0-10) General Acceptability: 1 item (scored 0-5)

Time frame

12 weeks

Patient-Reported Adherence to the Virtual Assistant (VA) System: 4-Item Feasibility Questionnaire

Adherence to the VA system, as a marker of feasibility, will be assessed using a 4-item questionnaire adapted from the study by An, M. et al. ("What really works in intervention? Using fidelity measures to support optimal outcomes." Physical Therapy, 100(5), pp. 757-765). This questionnaire will be completed by patients and is designed to evaluate key aspects of adherence. Each item is scored on a 4-point scale (0-3), with a total possible score of 12. Higher scores indicate greater adherence to the VA system.

Time frame

12 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

East and North Hertfordshire NHS Trust

Lead sponsor

Source ClinicalTrials.gov

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