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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AT009218 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This is a pilot study measuring physiologic and behavioral correlates of symptom severity in 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GERD Patients | Subjects with active GERD symptoms. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Beginning to end of study visit (1 hour or less for change in GSR) |
| 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. | Beginning to end of study visit (1 hour or less for change in HRV/RMSSD) |
| 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. | Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Adults with active GERD-related symptoms.
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Dossett, MD, PHD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Visit | A standardized visit (based on a pre-set question template) modeled after a primary care visit focused on evaluating GERD symptoms. |
| FG001 | 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?). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Visit | Patients with GERD receiving a standard medical visit |
| BG001 | Expanded Visit | Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to treat analysis. Subjects with missing GSR data (due to equipment malfunction) were not included in the final analysis. | Posted | Mean | Standard Deviation | micro-Siemens | Beginning to end of study visit (1 hour or less for change in GSR) |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Visit | Patients with GERD receiving a standard medical visit | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment | 1 subject developed gastroenteritis and presented to the emergency department where they received IV fluids. Adverse event deemed not related to the study intervention. |
Equipment malfunction led to incomplete data collection for some subjects, reducing the total number of subjects in some of the data analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Dossett, MD, PhD | University of California, Davis | 916-734-5367 | mdossett@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2020 | Aug 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| 2 weeks (baseline and 2 week follow-up) |
| 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]). | 2 weeks (baseline and 2 week follow-up) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Average Daily GERD Symptom Severity | Severity of GERD symptoms were assessed by participant self-report on a 7-day symptom diary for one week immediately prior to enrolling in the study. 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 values across each of the 7 days were averaged to create the average daily GERD symptom severity score. Adapted from: Miner P, et. al. Am J Gastroenterol. 2002 Jun;97(6):1332-1339. PMID: 12094846 | Mean | Standard Deviation | units on a scale |
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| Expanded Visit |
Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation |
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| 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. | Intent to treat analysis. | Posted | Mean | Standard Deviation | milliseconds | Beginning to end of study visit (1 hour or less for change in HRV/RMSSD) |
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| 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. | Intent to treat. Subjects with missing GSR data (due to equipment malfunction) were not included in the final analysis. | Posted | Mean | Standard Deviation | Index | Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR) |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks (baseline and 2 week follow-up) |
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| 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]). | Posted | Mean | Standard Deviation | Percent change | 2 weeks (baseline and 2 week follow-up) |
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|
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Expanded Visit | Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation | 0 | 16 | 0 | 16 | 0 | 16 |
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| D004066 | Digestive System Diseases |