Continuous Alcohol Monitoring for Pancreatitis
关键词
抽象
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.
日期
| 最后验证: | 03/31/2020 |
| 首次提交: | 04/14/2020 |
| 提交的预估入学人数: | 04/15/2020 |
| 首次发布: | 04/16/2020 |
| 上次提交的更新: | 04/27/2020 |
| 最近更新发布: | 04/28/2020 |
| 实际学习开始日期: | 05/31/2020 |
| 预计主要完成日期: | 05/31/2021 |
| 预计完成日期: | 05/31/2021 |
状况或疾病
干预/治疗
Other: Continuous alcohol monitoring
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Continuous alcohol monitoring Wearable BACtrack Skyn device | Other: Continuous alcohol monitoring BACtrack Skyn, is a novel transdermal blood alcohol sensor developed by BACtrack, a company established for police-grade breathalyzers, and winner of the Wearable Alcohol Biosensor Challenge sponsored National Institute on Alcohol Abuse and Alcoholism. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
结果
主要结果指标
1. Proportion of enrolled patients who wore the BACTrack sensor for at least 7 days within the 14-day period [up to 14 days]
次要成果指标
1. Acceptability of the BACtrack Skyn using the System Usability Scale (SUS) [14 days]
2. Blood alcohol concentration (BACtrack breathalyzer) [up to 14 days]
3. Patient-reported alcohol consumption [up to 14 days]
4. Urine alcohol consumption [14 days]
5. Patient-reported pain [up to 14 days]
