Ambulatory Alcohol Detoxification With Remote Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of participants completing the eight-day protocol using Soberlink Device
研究概览
简要总结
This study is designed to examine the feasibility and impact of the use of remote monitoring devices during an outpatient ambulatory alcohol detoxification treatment for patients with alcohol use disorders.
详细描述
The study will include 30 subjects with a diagnosis of alcohol use disorder. The study uses a breathalyzer device with facial recognition to confirm the patient's identity and sends the information to the study staff using cellular technology. A second device is used which is a wireless blood pressure cuff that connects to the patient's smartphone and sends blood pressure and heart rate measurements directly to the study physician for enhanced monitoring during alcohol withdrawal management. The duration of the study is 8 days, starting with an initial appointment to set up the equipment. Throughout the study, surveys are completed by subjects in regards to their experience with the device. Subjects undergo a brief 30-60 minute appointment on the first day of the study, appointments as needed throughout the study, and an appointment on the last day of the study to check in with the physician for ongoing ambulatory management of alcohol withdrawal, including medication adjustments if indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female Subject between the ages of 21-75 years old
- •Meeting DSM-V criteria for alcohol use disorder and needing medically supervised detoxification based on medical history and pattern of alcohol use delineated by timeline follow back method.
- •Has 24/7 easy access to a hospital. This is to ensure easy admission to a higher level of care if indicated.
- •Willing to use the Soberlink Device to provide blood alcohol concentration (BAC)
- •Willing to use the blood pressure cuff to provide blood pressure and pulse (BPPT) measurement
- •Willing to sign an informed consent
排除标准
- •BAC above the legal driving limit at the time of screening
- •Developing symptoms or history of symptoms of severe withdrawal syndrome such as fever, disorientation, drenching sweats, severe tachycardia, or severe hypertension
- •History of delirium tremens or seizures
- •Co-morbid medical or psychiatric history requiring inpatient admission for careful monitoring
- •Subject unwilling to respond to redirection when blood pressure and heart rate warning signs are triggered
- •Does not have an iPhone, iPod, iPad, or Apple Watch with iOS 7.0 or later, or does not have an Android phone or tablet with Android 4.4 or later
- •Unable or unwilling to properly use the monitoring devices, or find the monitoring devices an obstruction to comply with treatment
- •Subject that is non-English speaking
- •Subject that is a child, adolescent, or cognitively impaired
结局指标
主要结局
Number of participants completing the eight-day protocol using Soberlink Device
时间窗: Baseline to end of study (eight days).
The Subject will be enrolled on day one and return to the site for an evaluation by the study staff on day eight. They will be seen by study staff as needed throughout the study for withdrawal management. If Subject complies with the guidelines of the study, medications will be prescribed. On or after the last day of the study, the Subject will return to the study site for a final evaluation outcomes.
次要结局
- Adverse events(Baseline to end of study (eight days))
- Subject's self-report on effect of breathalyzer device on their behavior(Baseline to end of study (eight days))
- Scheduled Blood pressure and heart rate test is missed or out of range(Baseline to end of study (eight days))
- Missed Soberlink test(Baseline to end of study (eight days))
- Positive BAC test received from Soberlink(Baseline to end of study (eight days))
- Subject not agreeable to clinical recommendations(Baseline to end of study (eight days))
研究者
Anna Lembke
Clinical Associate Professor
Stanford University