Correlates of GERD Symptom Severity
2020年12月22日 更新者：Michelle Dossett, MD, PhD, MPH、Massachusetts General Hospital
Physiologic and Behavioral Correlates of GERD Symptom Severity
This is a pilot study measuring physiologic and behavioral correlates of symptom severity in adult patients with gastroesophageal reflux disease (GERD).
研究概览
地位
完全的
条件
详细说明
Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit with a study clinician regarding their symptoms.
We will measure heart rate variability and galvanic skin response in patients during the visits and video record the visits.
Subjects will complete a daily GERD symptom diary for 2 weeks and then return to the study center to complete additional questionnaires and an exit interview.
研究类型
观察性的
注册 (实际的)
24
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Adults with active GERD-related symptoms.
描述
Inclusion Criteria:
- Adults ages 21-70 years old
- Heartburn symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7 day baseline symptom diary
- English language proficiency
- Willingness to be videotaped and connected to physiologic monitoring devices during the visit
Exclusion Criteria:
- Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review
- Heavy alcohol use (> 6 drinks/week for women and > 13 drinks/week for men)
- Pregnant women.
- Dementia or significant memory difficulties
- Severe, unstable psychiatric disease
- Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level deemed likely to interfere with the study
- Failure to complete the baseline symptom diary for at least 6 of 7 days
- Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids, H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on a stable regimen)
- Allergy to adhesives
- Inability to provide informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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GERD Patients
Subjects with active GERD symptoms.
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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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Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
大体时间：Beginning to end of study visit (1 hour or less for change in GSR)
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Galvanic skin response (GSR) was measured with a device from ADInstruments during the baseline study visit.
Values ranged from 0.93 - 12 micro-Siemens (μS).
Change in GSR was calculated as mean value of GSR for the first 2 minutes of the study visit minus mean value of GSR for the last 2 minutes of the study visit.
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Beginning to end of study visit (1 hour or less for change in GSR)
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Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
大体时间：Beginning to end of study visit (1 hour or less for change in HRV/RMSSD)
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Heart rate variability (HRV) was measured using a device from ADInstruments gathering data at 256 Hz.
We used the RMSSD (Root Mean Square of the Successive Differences) value as a proxy for high frequency HRV.
Measured values ranged from 0 - 150 msec.
Change in high frequency HRV was calculated as the RMSSD value for the first 5 minutes of the study visit minus the RMSSD value for the last 5 minutes of the study visit.
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Beginning to end of study visit (1 hour or less for change in HRV/RMSSD)
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Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks
大体时间：Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR)
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Concordance in galvanic skin response (GSR) between patient and physician was calculated using an established approach (Marci CD, 2007; PMID 17299296) to create a single index value for the visit.
The natural logarithm of this value was taken to reduce skew.
A value greater than 0 means more than 50% concordance in the data, a value less than zero means less than 50% concordance in the data.
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Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Post GERD Symptom Severity
大体时间：2 weeks (baseline and 2 week follow-up)
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GERD symptom severity at follow-up was assessed by self-report on a 7-day symptom diary (symptoms collected days 8-14 after the study visit).
Possible daily scores ranged from 0-12 with higher scores indicating more severe symptoms (sum of daytime heartburn, nighttime heartburn, and acid regurgitation symptoms each rated 0-4 in severity [none, mild, moderate, severe, very severe]).
Daily scores across the 7 days were averaged to create the Post GERD symptom severity score.
Adapted from: Miner P, et.
al. Am J Gastroenterol. 2002.
PMID: 12094846.
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2 weeks (baseline and 2 week follow-up)
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Percent Change in Patient's GERD Symptoms
大体时间：2 weeks (baseline and 2 week follow-up)
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Percent change in patient's GERD symptoms was calculated as: (post GERD symptom severity - baseline GERD symptom severity) / baseline GERD symptom severity*100. GERD symptom severity scores were averaged across 7 day baseline and follow-up periods from a symptom diary (adapted from Miner P, 2002; PMID 12094846). Scores ranged from 0-12 with higher scores indicating more severe symptoms (sum of daytime heartburn, nighttime heartburn, and acid regurgitation each rated 0-4 in severity [none, mild, moderate, severe, very severe]). |
2 weeks (baseline and 2 week follow-up)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michelle Dossett, MD, PHD, MPH、Massachusetts General Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年5月22日
初级完成 (实际的)
2019年5月3日
研究完成 (实际的)
2019年5月7日
研究注册日期
首次提交
2016年12月20日
首先提交符合 QC 标准的
2017年1月11日
首次发布 (估计)
2017年1月13日
研究记录更新
最后更新发布 (实际的)
2021年1月15日
上次提交的符合 QC 标准的更新
2020年12月22日
最后验证
2020年12月1日
更多信息
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.