NCT06400927招募中不适用
Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure: A Randomized Controlled Pilot Study: ASSIST-HF SIRIO
East and North Hertfordshire NHS Trust1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Acceptability of the intervention to users (participants)
研究概览
简要总结
The aim of this pilot randomized study is to examine whether integrating the SIRIO-HF virtual assistant (VA) into the outpatient management of participants recently discharged from hospital with a new diagnosis of heart failure (HF), may reduce the need for regular medical assessment and the healthcare burden, reduce variability in healthcare, and meet 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
- Single Group
- 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
- •Newly diagnosed HF with New York Heart Association class II-III symptoms at discharge
排除标准
- •Known prior history of HF
- •Severe comorbidities that could affect protocol adherence, in the opinion of the investigator
- •Alternative diagnosis for symptoms such as chronic obstructive pulmonary disease
- •Dementia or other cognitive impairment
- •Currently involved in another interventional clinical trial
研究组 & 干预措施
VA-guided arm
Experimental
干预措施: HF-guided VA (Other)
Standard-of-care arm
Placebo Comparator
干预措施: Standard-of-care (Other)
结局指标
主要结局
Acceptability of the intervention to users (participants)
时间窗: 12 weeks
This will be assessed utilising an adapted 'acceptability of intervention measure' (AIM)
次要结局
未报告次要终点
研究者
Prof Diana Gorog
Professor
East and North Hertfordshire NHS Trust
研究点 (1)
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