Sparrow App Guided Evaluation (SAGE) Vanguard Trial for Aortic Stenosis in Adults Aged Seventy and Older (SAGE-AS)
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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. |
The device is a FDA & HC approved mobile application, the Stethophone (developed by Sparrow BioAcoustics), that transforms a smartphone into a digital stethoscope and analytic tool able to identify murmurs that may indicate aortic stenosis. |
|
无干预：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of new diagnosis of moderate or severe aortic stenosis on transthoracic echo/1000 patients screened of patients over 70 years
大体时间：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 |
Within 3 months after enrolment.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of eligible participants screened during intervention periods
大体时间：From enrollment until Day 1
|
Proportion of eligible participants screened during intervention periods |
From enrollment until Day 1
|
|
Distribution of algorithm outputs
大体时间：From enrollment until Day 1
|
Distribution of algorithm outputs as normal, suggestive of aortic stenosis, other murmur detected, or inconclusive |
From enrollment until Day 1
|
|
Proportion completing transthoracic echocardiography after an abnormal or inconclusive result
大体时间：Enrollment to 3 months
|
Proportion of participants completing transthoracic echocardiography after an abnormal or inconclusive result |
Enrollment to 3 months
|
|
Average time from abnormal screen to echocardiography
大体时间：Enrollment to transthoracic echocardiography, assessed up 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
大体时间：ECHO confirmation to valve clinic referral, an average of 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
大体时间：enrollment to ECHO confirmation or valve clinic referral whichever comes last, an average of 3 months
|
|
enrollment to ECHO confirmation or valve clinic referral whichever comes last, an average of 3 months
|
合作者和调查者
合作者
调查人员
- 首席研究员：Nicolas Bowers, MD MSc FRCPC FACC FSCAI、Sunnybrook Health Sciences Centre
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SAGE-AS
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The Aggregate data will be presented and/or published. The IPD will not be available keeping patients privacy in mind.
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