Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Stanford、California、美国、94305
- Stanford Healthcare
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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:
I. ≥ 18 years of age
II. Patient at Stanford Health Care with evidence of CAD (atherosclerosis of one or more coronary arteries or clinical evidence or documentation of ischemia, infarction) OR a diagnosis related to CAD (i.e. ischemic heart disease ICD-10-Code: I20-25).
III. Prescription of a P2Y12 antagonist and/or a statin for an anticipated duration of at least 3 months following discharge
IV. Possession of a compatible (iPhone 5s or later; OS 8.1 or higher) smartphone with an active phone number and data plan. The smartphone must be in continued possession of the participant. It may not be a shared device and must exclusively remain in the possession of the participant during the study period. The smartphone must have an active cellular phone number and cellular data subscription. Wi-Fi internet capability is not a substitute for an active cellular data plan.
V. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
VI. Willing to have the mobile application installed on a smartphone and use it every day during the entire study period VII. Willing to provide oral confirmation indicating that he/she is currently not using a medication adherence application.
VIII. Ability to read and understand English.
Exclusion criteria:
Any potential participant who meets any of the following criteria will be excluded from participating in the study:
I. Anticipated inability to adhere to the mobile application (BrightHeart®) based on opinion of site Principal Investigator (PI).
II. Current use of adherence tracking devices, electronic, smartphone or computer applications, including but not limited to smart pill bottles, pill timers, radiofrequency tagged medications or dispensers, mobile applications, or automated phone reminders. Pill organizers that remind participants when to take medicine with beeps or alerts are exclusion.
a. Note: Pharmacy and health care plan automated refill reminders are permitted and are not exclusion. Pill organizers or containers that only compartmentalize a participant's medications based on days of the week are not exclusion.
III. Cognitive, visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone. Co-morbidities that would preclude participation (e.g. ongoing chemotherapy) or planned hospitalization for complex procedures as determined by the PI (e.g. bypass, valve or aortic surgery, transarterial valve replacement) IV. End-stage of one of the following: heart failure (using left ventricular assist device or listed for heart transplantation), renal disease, lung disease, liver disease.
V. Any condition with a life expectancy less than 3 months. VI. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator VII. Any other condition as determined by the PI.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:smartphone-based cardiac rehabilitation
The BrightHeart® mobile application is installed on the smartphone and a heart coach set up and guides the participant through a cardiac care program.
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BrightHeart® has two components: smartphone mobile based application and a human coach.
It is a combined approach of medication adherence, exercise, diet, sleep and stress reduction.
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无干预:Control
Standard-of-care alone.
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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 |
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Medication adherence
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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The proportion of days coverd (PDC) expressed as a percentage but considered as a continuous variable of the composite of the prescribed P2Y12 receptor antagonist and/or the statin.
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Baseline through End of Study visit - approximately 90 days per participant.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Medication adherence II
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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Proportion of participants with PDC ≥ 80% of the composite of the P2Y12 receptor antagonist and/or the statin
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Baseline through End of Study visit - approximately 90 days per participant.
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Medication adherence III
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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The PDC of each medication of the composite
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Baseline through End of Study visit - approximately 90 days per participant.
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Medication adherence IV
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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Proportion of participants with PDC ≥ 80% of each of the composite
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Baseline through End of Study visit - approximately 90 days per participant.
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Medication adherence V
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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Mean time from discharge to first fill
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Baseline through End of Study visit - approximately 90 days per participant.
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Medication persistence
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors I
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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Serum LDL-C at End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors II
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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Proportion of participants within target blood pressure (<140/90 mmHg or <130/80 mmHg for patients with diabetes mellitus or chronic kidney disease) at End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors III
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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Proportion of participants with HbA1c ≤ 7% at End of Study (only if diabetes mellitus was known at time of inclusion)
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors IV
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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Change in body weight from baseline to End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors V
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors VI
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors VII
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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Physical activity at End of Study (measured by a physical acitivity questionnaire)
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Baseline through End of Study visit - approximately 90 days per participant.
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Exploratory I: Rehospitalization
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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30-day rehospitalization for any reason
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Baseline through End of Study visit - approximately 90 days per participant.
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Exploratory II: Cardiovascular outcomes
大体时间:Baseline through End of Study visit - approximately 90 days per participant.
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Major adverse cardiac events (MACE) defined as: Death, myocardial infarction, acute coronary syndrome, out of hospital cardiac arrest, stent thrombosis, repeat revascularization at 90 days
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Baseline through End of Study visit - approximately 90 days per participant.
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合作者和调查者
调查人员
- 首席研究员:Minang (Mintu) Turakhia, MD、Stanford University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
其他研究编号
- 39555
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
BrightHeart®的临床试验
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Chung-Ang University Hosptial, Chung-Ang University...未知
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Coopervision, Inc.完全的