Atrial Fibrillation (AF)
Conditions
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.
Interventions
OTHERvirtual assistant
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.
OTHERStandard AF care
AF care provided via the National Health System (NHS) standard AF care system
Sponsors
East and North Hertfordshire NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Documented diagnosis of AF within the last 6 months 3. 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 4. Ability to understand and comprehend the study rationale, design, and process.
Exclusion criteria
1. Severe comorbidities (such as physical impairment, cognitive impairment, and hearing loss) that could affect protocol adherence, in the opinion of the investigator 2. Chronic Kidney Disease (CKD) stage 4-5 or on dialysis 3. Medical illness with a life expectancy of less than 1 year 4. Alternative potentially reversible causes of AF (such as surgery, sepsis, or thyroid dysfunction) 5. Dementia or other cognitive impairment 6. Currently involved in another AF interventional clinical trial 7. Being pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| How acceptable is the Virtual Assistant (VA) system as assessed by Sekhon's Theoretical Framework of Acceptability (TFA) questionnaire. | 12 weeks | 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) |
| Patient-Reported Adherence to the Virtual Assistant (VA) System: 4-Item Feasibility Questionnaire | 12 weeks | 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. |
Contacts
Primary ContactSogol Koolaji, MD-MPH
Backup ContactDiana A Gorog, MD, PhD
Outcome results
None listed