Correlates of GERD Symptom Severity
Status: | Recruiting |
---|---|
Conditions: | Gastroesophageal Reflux Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 21 - 70 |
Updated: | 3/1/2019 |
Start Date: | May 22, 2017 |
End Date: | January 2020 |
Contact: | Emma Needles |
Email: | eneedles@partners.org |
Phone: | 617-643-6062 |
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).
adult patients with gastroesophageal reflux disease (GERD).
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.
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.
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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-6062
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