Trial Outcomes & Findings for Correlates of GERD Symptom Severity (NCT NCT03020550)
NCT ID: NCT03020550
Last Updated: 2021-01-15
Results Overview
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.
COMPLETED
24 participants
Beginning to end of study visit (1 hour or less for change in GSR)
2021-01-15
Participant Flow
Participant milestones
| Measure |
Standard Visit
A standardized visit (based on a pre-set question template) modeled after a primary care visit focused on evaluating GERD symptoms.
|
Expanded Visit
A standardized visit (based on a pre-set question template) modeled after an integrative medicine visit for GERD symptoms. The Expanded Visit includes all of the questions in the Standard Visit plus additional questions about the nature of the GI symptoms (e.g., taste of reflux, food cravings and aversions), other health issues, and the patient's temperament (e.g., shy, anxious, caring). Some of these questions address the patient's "constitutional type" as might be assessed by some integrative practitioners (e.g., tell me about your sleep; do you tend to be hot or cold?).
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
16
|
|
Overall Study
COMPLETED
|
8
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Correlates of GERD Symptom Severity
Baseline characteristics by cohort
| Measure |
Standard Visit
n=8 Participants
Patients with GERD receiving a standard medical visit
|
Expanded Visit
n=16 Participants
Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 16.7 • n=7 Participants
|
39.9 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
16 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Average Daily GERD Symptom Severity
|
3.90 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
2.95 units on a scale
STANDARD_DEVIATION 1.2 • n=7 Participants
|
3.26 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Standard Visit
n=7 Participants
Patients with GERD receiving a standard medical visit
|
Expanded Visit
n=9 Participants
Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation
|
|---|---|---|
|
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
|
-1.70 micro-Siemens
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Beginning to end of study visit (1 hour or less for change in HRV/RMSSD)Population: Intent to treat analysis.
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.
Outcome measures
| Measure |
Standard Visit
n=8 Participants
Patients with GERD receiving a standard medical visit
|
Expanded Visit
n=16 Participants
Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation
|
|---|---|---|
|
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
|
2.5 milliseconds
Standard Deviation 10.3
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Standard Visit
n=7 Participants
Patients with GERD receiving a standard medical visit
|
Expanded Visit
n=9 Participants
Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation
|
|---|---|---|
|
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
|
0.199 Index
Standard Deviation 0.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard Visit
n=8 Participants
Patients with GERD receiving a standard medical visit
|
Expanded Visit
n=16 Participants
Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation
|
|---|---|---|
|
Post GERD Symptom Severity
|
3.77 score on a scale
Standard Deviation 1.48
|
2.41 score on a scale
Standard Deviation 1.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 \[none, mild, moderate, severe, very severe\]).
Outcome measures
| Measure |
Standard Visit
n=8 Participants
Patients with GERD receiving a standard medical visit
|
Expanded Visit
n=16 Participants
Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation
|
|---|---|---|
|
Percent Change in Patient's GERD Symptoms
|
10.3 Percent change
Standard Deviation 45
|
-12.2 Percent change
Standard Deviation 58
|
Adverse Events
Standard Visit
Expanded Visit
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Visit
n=8 participants at risk
Patients with GERD receiving a standard medical visit
|
Expanded Visit
n=16 participants at risk
Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation
|
|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis
|
12.5%
1/8 • Number of events 1 • 2 weeks
|
0.00%
0/16 • 2 weeks
|
Additional Information
Michelle Dossett, MD, PhD
University of California, Davis
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place