Cardiovascular Precision Medicine & Remote Intervention - Pilot Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Blood pressure readings
研究概览
简要总结
This exploratory / proof of concept study aims to evaluate whether it is possible to identify at-risk patients based on EHR review of blood pressure fluctuation over time and cholesterol levels, recruit those patients, and engage them in a remote intervention protocol.
详细描述
Patients will be screened for participation based on EHR blood pressure measurements. Those who potential meet the prespecified criteria will be approached during a clinic visits about participation in the study. Patients who agree to participate and sign an informed consent will be given an automatic blood pressure monitor and their contact details will be obtained in order to enable administration of the intervention.
The intervention's theoretical underpinnings are principles previously identified as promising or helpful in health care management of at-risk patients. The principles are:
- "Hovering", using a risk marker, to guide an intervention
- Addressing posttraumatic avoidance as a way to improve adherence, using an imaginal exposure paradigm.
- Using a remote interventionist via a telemetric interface that involves active, dynamic patient engagement rather than automated processes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •The patient must meet all of below criteria to be eligible for enrollment in the study:
- •The patient is > 18 years of age at enrollment.
- •The patient is followed at the cardiology clinic and was diagnosed with hypertension and hypercholesterolemia more than 12 months prior to EHR screening, and has been prescribed at least one antihypertensive medication and at least one lipid-lowering agent over the 6 months prior to EHR screening
- •The patient can be reached either by phone or via an internet-enabled device.
- •The patient speaks English or Spanish at a level that allows them to understand the study procedures and consent to the study.
- •The coefficient of Variation (CoV) of at least three systolic blood pressure measurements present in the EHR over the 12 months prior to EHR screening is > 10%.
排除标准
- •None of the following may be present if the patient is to be eligible for enrollment in the study:
- •The patient is suffering from a psychiatric or developmental disorder that prevents him or her from understanding the protocol or engaging in the intervention (e.g., autistic disorder, psychosis).
- •The investigator determines that a remote intervention paradigm is not advisable because of specific patient or environmental characteristics (investigator discretion).
- •The patient is suffering from a medical disorder that makes control of blood pressure especially challenging or unlikely (e.g., end stage renal disease, uncontrolled endocrine disorders)
- •Unstable blood pressure or hyperlipidemia that may require change in therapy in the 3 months after enrolment
- •Significant heart failure (NYHA > 2) or ejection fraction < 50%
- •Recent thromboembolic events such as a myocardial infarction, stroke, acute coronary syndrome, transient ischemic attack in the 6 months prior to enrolment
- •Any arrythmia requiring medical or device therapy within 6 months prior to enrolment.
- •The patient is hospitalized or was hospitalized in the last 6 months prior to enrollment. Patients hospitalized after enrollment are not excluded.
- •PI decision to exclude (for example - PI determines that the patient may be harmed by the study for a reason that is not covered by the exclusion criteria)
- •Withdrawal Criteria
- •Participants will be withdrawn from the intervention if they wish to not be called anymore. If they agree to continue to have their data collected from the medical chart, they would not be withdrawn from the study. Patients will be withdrawn from the study (their pre-withdrawal data will be used for the primary intent-to-treat analysis unless prohibited) for the following reasons:
- •The patient dies.
- •The patient becomes psychotic as defined in DSM-V, or suffers from an event that makes him or her unable to participate in the intervention (e.g. loss of hearing, loss of cognitive ability).
- •The patient's care is transferred to another center, and it is impossible to get the primary and secondary outcome data.
- •Patient decision
- •Investigator decision
- •DSMC or IRB determination related to the occurrence of an adverse event, or for any other reason.
结局指标
主要结局
Change in Blood pressure readings
时间窗: Baseline and Week 12
The change in systolic blood pressure from Visit 1 (enrollment) to Visit 9 (week 12) will be tested using a paired t-test. Changes will be based on measures taken with the same monitor (clinic or home) at both time points if possible; if changes with both clinic and home monitors are available, then measures using the clinic monitor will be used. Blood pressure readings (min max mean and fluctuation) before the intervention commences and during and after it, in an intent-to treat paradigm.
次要结局
- Proportion of high risk patients successfully engaged(12 weeks)
- Change in Blood Pressure Variability Index(6 months prior to screening and Week 12)
- Proportion of clinic patients "at risk"(Baseline)
- Change in cholesterol level(Visit 1 (Week 0) and Visit 9 (Week 12))
- Proportion of high risk who agree to participate(Baseline)
- Change in blood pressure(Visit 1 (Week 0) and Visit 9 (Week 12))
研究者
Eyal Shemesh
Professor
Icahn School of Medicine at Mount Sinai