GERD
Conditions
Keywords
GERD, Galvanic Skin Response, Heart Rate Variability
Brief summary
This is a pilot study measuring physiologic and behavioral correlates of symptom severity in adult patients with gastroesophageal reflux disease (GERD).
Detailed description
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.
Interventions
None listed
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later | Beginning to end of study visit (1 hour or less for change in GSR) | 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. |
| Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later | Beginning to end of study visit (1 hour or less for change in HRV/RMSSD) | 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. |
| Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks | Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post GERD Symptom Severity | 2 weeks (baseline and 2 week follow-up) | 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. |
| Percent Change in Patient's GERD Symptoms | 2 weeks (baseline and 2 week follow-up) | 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 \[none, mild, moderate, severe, very severe\]). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Visit Patients with GERD receiving a standard medical visit | 8 |
| Expanded Visit Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation | 16 |
| Total | 24 |
Baseline characteristics
| Characteristic | Standard Visit | Expanded Visit | Total |
|---|---|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 15.7 | 41.1 years STANDARD_DEVIATION 16.7 | 39.9 years STANDARD_DEVIATION 16.1 |
| Average Daily GERD Symptom Severity | 3.90 units on a scale STANDARD_DEVIATION 1.7 | 2.95 units on a scale STANDARD_DEVIATION 1.2 | 3.26 units on a scale STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 16 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 10 Participants | 17 Participants |
| Region of Enrollment United States | 8 participants | 16 participants | 24 participants |
| Sex: Female, Male Female | 5 Participants | 13 Participants | 18 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 16 |
| other Total, other adverse events | 1 / 8 | 0 / 16 |
| serious Total, serious adverse events | 0 / 8 | 0 / 16 |
Outcome results
Primary
Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
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.
Time frame: Beginning to end of study visit (1 hour or less for change in GSR)
Population: Intent to treat analysis. Subjects with missing GSR data (due to equipment malfunction) were not included in the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Visit | Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later | -0.94 micro-Siemens | Standard Deviation 1.3 |
| Expanded Visit | Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later | -1.70 micro-Siemens | Standard Deviation 1.1 |
Comparison: The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in GSR (galvanic skin response). No term for visit type assignment was included in the model.p-value: 0.034ANOVA
Primary
Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
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.
Time frame: Beginning to end of study visit (1 hour or less for change in HRV/RMSSD)
Population: Intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Visit | Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later | -0.26 milliseconds | Standard Deviation 8.3 |
| Expanded Visit | Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later | 2.5 milliseconds | Standard Deviation 10.3 |
Comparison: The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in RMSSD (high frequency HRV). No term for visit type assignment was included in the model.p-value: 0.56ANOVA
Primary
Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks
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.
Time frame: Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR)
Population: Intent to treat. Subjects with missing GSR data (due to equipment malfunction) were not included in the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Visit | Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks | -0.0536 Index | Standard Deviation 0.19 |
| Expanded Visit | Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks | 0.199 Index | Standard Deviation 0.38 |
Comparison: The outcome measure was calculated using a Pearson correlation to compare the session index representing the amount of concordance in GSR between patient and physician and the percent change in patients' GERD symptoms. Visit type assignment was not included in the analysis.p-value: 0.8Pearson's correlation test
Other Pre-specified
Percent Change in Patient's GERD Symptoms
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 \[none, mild, moderate, severe, very severe\]).
Time frame: 2 weeks (baseline and 2 week follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Visit | Percent Change in Patient's GERD Symptoms | 10.3 Percent change | Standard Deviation 45 |
| Expanded Visit | Percent Change in Patient's GERD Symptoms | -12.2 Percent change | Standard Deviation 58 |
Other Pre-specified
Post GERD Symptom Severity
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.
Time frame: 2 weeks (baseline and 2 week follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Visit | Post GERD Symptom Severity | 3.77 score on a scale | Standard Deviation 1.48 |
| Expanded Visit | Post GERD Symptom Severity | 2.41 score on a scale | Standard Deviation 1.67 |