Sparrow App Guided Evaluation (SAGE) Vanguard Trial for Aortic Stenosis in Adults Aged Seventy and Older
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Number of new diagnosis of moderate or severe aortic stenosis on transthoracic echo/1000 patients screened of patients over 70 years
研究概览
简要总结
The purpose of this research is to look at an approved intervention (Stethophone application) to obtain additional information about improving detection of moderate or severe aortic stenosis when compared with usual standard of care.
详细描述
This study employs a stepped-wedge cluster randomized design involving four primary care practices affiliated with KMH Cardiology. Each family practice constitutes a single cluster.
All participating practices will start as usual standard of care. At three-month intervals, one practice will be randomly selected to crossover from usual standard of care (control group) to the intervention group. There will be a 2-week wash in period when a family practice crosses over from control to intervention. This process will continue until all practices have implemented the intervention, resulting in full intervention by 15 months.
Investigators hypothesize that the Sparrow screening pathway will result in a higher proportion of patients with a positive echo for moderate or severe aortic stenosis than usual care without protocol driven screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 70 years or older at the time of consent.
- •Written informed consent from participant
- •Receiving care at a participating primary care practice during the study period.
排除标准
- •Known moderate or severe aortic stenosis before enrolment.
- •Prior surgical or transcatheter aortic valve replacement.
- •Any condition that, in the opinion of the investigator or treating clinician, would preclude informed consent or make participation impractical or unsafe.
研究组 & 干预措施
Intervention
During intervention periods, trained clinic personnel will obtain heart sound recordings at three standard chest positions using the Stethophone application, with at least 30 seconds of recording at each position.
干预措施: Stethophone (Device)
Standard of Care
No study procedures. Patients will be consented for obtaining data related to ECHO confirmation for of moderate or severe aortic stenosis (if applicable) followed by referral for valve clinic assessment (if need be) for the duration of this study.
结局指标
主要结局
Number of new diagnosis of moderate or severe aortic stenosis on transthoracic echo/1000 patients screened of patients over 70 years
时间窗: Within 3 months after enrolment.
Determine whether Sparrow app based screening increases the number of patients with a new diagnosis of moderate or severe aortic stenosis confirmed by transthoracic echo within 3 months
次要结局
- Proportion of eligible participants screened during intervention periods(From enrollment until Day 1)
- Distribution of algorithm outputs(From enrollment until Day 1)
- Proportion completing transthoracic echocardiography after an abnormal or inconclusive result(Enrollment to 3 months)
- Average time from abnormal screen to echocardiography(Enrollment to transthoracic echocardiography, assessed up to 3 months)
- Average time from confirmed diagnosis to referral to valve clinic, where applicable(ECHO confirmation to valve clinic referral, an average of 3 months)
- Diagnostic yield of transthoracic echocardiography(enrollment to ECHO confirmation or valve clinic referral whichever comes last, an average of 3 months)