Application of a Wearable Alcohol Sensor for Prevention of Pancreatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Proportion of enrolled patients who wore the BACTrack sensor for at least 7 days within the 14-day period
研究概览
简要总结
The purpose the research is to demonstrate the feasibility of using a transdermal alcohol sensing device (BACtrack Skyn), and to correlate biological and self-reported alcohol measures with the transdermal alcohol measures in patients with a history of pancreatitis. The results from this study will inform tailored, self-directed interventions for reducing alcohol consumption in persons with pancreatitis.
详细描述
Alcohol is the leading cause of recurrent acute and chronic pancreatitis, which greatly elevates the risk of pancreatic cancer. Reducing alcohol intake in patients with a history of alcoholic pancreatitis prevents progression of pancreatitis. Provider-based education on alcohol reduction has not translated to sustainable behaviors change, and more effective and scalable interventions are needed. Wearable alcohol sensors can empower patient-directed behavior change through real-time feedback on alcohol levels in the blood. BACtrack Skyn, the winner of NIAAA's Wearable Alcohol Biosensor Challenge, is a validated transdermal alcohol sensor that estimates blood alcohol concentration. In this pilot study, the investigators aim to (a) determine the feasibility and acceptability of using BACtrack Skyn to monitor changes in blood alcohol concentration among patients at risk for pancreatitis, (b) assess correlations between alcohol levels measured with BACtrack Skyn, breathalyzer, patient-reported alcohol consumption, and urine alcohol metabolite levels, (c) explore whether the use of a wearable alcohol sensor results in a decrease in alcohol consumption over a two-week period. Sixteen participants with known history of alcoholic pancreatitis will be assigned to wearing BACtrack Skyn for 2 weeks with the goal of not exceeding a blood alcohol concentration of 0.08%. Patient-reported drinking history, urine will be collected to correlate reported drinking levels and alcohol metabolic levels with the blood alcohol concentration readings in BACtrack Skyn. Findings from this study will be used as preliminary data to support and optimize subsequent grant applications and inform larger, randomized trials. The proposed study aligns closely with the mission of Cedars-Sinai and contributes to the growing body of research focusing on novel technologies for cancer prevention and control, as well as translational studies on alcoholic gastrointestinal diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years at the time of eligibility assessment
- •History of at least one AP per Revised Atlanta Classification (20) within past 3 years from screening, which requires two of the following evidence of pancreatitis:
- •Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back)
- •Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal
- •Characteristic findings of AP on contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MRI) or transabdominal ultrasonography
- •Access to a mobile or portable device that has the capability to sync to the BACtrack sensor and internet connection for syncing purposes.
排除标准
- •Pancreatitis presumed to be related to: gallstones, medication, trauma, autoimmune pancreatitis, post-ERCP pancreatitis, pancreatic ductal adenocarcinoma, suspected cystic neoplasm, neuroendocrine tumors, and other uncommon tumors.
- •Episode of acute pancreatitis requiring hospitalization in the past 4 weeks.
- •Current medical or psychiatric illnesses that in the investigator's opinion would compromise their ability to tolerate study procedures.
- •Currently incarcerated.
- •Known pregnancy.
结局指标
主要结局
Proportion of enrolled patients who wore the BACTrack sensor for at least 7 days within the 14-day period
时间窗: up to 14 days
Feasibility based on proportion of patients who wore the BACTrack sensor for at least 50% of study duration
次要结局
- Acceptability of the BACtrack Skyn using the System Usability Scale (SUS)(14 days)
- Blood alcohol concentration (BACtrack breathalyzer)(up to 14 days)
- Patient-reported alcohol consumption(up to 14 days)
- Urine alcohol consumption(14 days)
- Patient-reported pain(up to 14 days)
研究者
Gillian Gresham
Assistant Professor
Cedars-Sinai Medical Center