AI-guided AF Treatment
Artificial Intelligent Guided Treatment of Atrial Fibrillation: A Randomized Controlled Pilot Study
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Typical duration for not_applicable
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
May 21, 2025
CompletedStudy Start
First participant enrolled
July 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 26, 2028
July 17, 2025
July 1, 2025
2.9 years
May 21, 2025
July 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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)
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.
12 weeks
Study Arms (2)
Standard of Care
PLACEBO COMPARATORVirtual Assistant
EXPERIMENTALInterventions
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.
AF care provided via the National Health System (NHS) standard AF care system
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- Dementia or other cognitive impairment
- Currently involved in another AF interventional clinical trial
- Being pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
An M, Dusing SC, Harbourne RT, Sheridan SM; START-Play Consortium. What Really Works in Intervention? Using Fidelity Measures to Support Optimal Outcomes. Phys Ther. 2020 May 18;100(5):757-765. doi: 10.1093/ptj/pzaa006.
PMID: 31944249BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2025
First Posted
July 17, 2025
Study Start
July 15, 2025
Primary Completion (Estimated)
May 26, 2028
Study Completion (Estimated)
May 26, 2028
Last Updated
July 17, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share