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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Placebo Comparator |
| |
| Virtual Assistant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| virtual assistant | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sogol Koolaji, MD-MPH | Contact | +447394455974 | sogol.koolaji@nhs.net | |
| Diana A Gorog, MD, PhD | Contact | 01707247512 | d.gorog@imperial.ac.uk |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31944249 | Background | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| Standard AF care | Other | AF care provided via the National Health System (NHS) standard AF care system |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |