Artificial Intelligent Guided Treatment of Atrial Fibrillation: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- How acceptable is the Virtual Assistant (VA) system as assessed by Sekhon's Theoretical Framework of Acceptability (TFA) questionnaire.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Standard of Care
干预措施: Standard AF care (Other)
Virtual Assistant
干预措施: virtual assistant (Other)
结局指标
主要结局
How acceptable is the Virtual Assistant (VA) system as assessed by Sekhon's Theoretical Framework of Acceptability (TFA) questionnaire.
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点