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Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) Platform
NCT02436057 · View on ClinicalTrials.gov ↗
Study Summary
Through a four-year grant awarded to the University of California at Los Angeles in 2009, Dr. Brennan Spiegel served as a principal investigator (PI) for a project to develop and initially validate a bank of items to assess gastrointestinal (GI) symptoms for the National Institutes of Health's (NIH's) Patient Reported Outcomes Measurement Information System (PROMIS). By the end of the grant period in July 2013, the project team had successfully developed and initially validated eight scales measuring the most common GI symptoms. Afterwards, Dr. Spiegel's PROMIS team joined forces with the UCLA Computing Technology Research Laboratory (CTRL) and the University of Michigan Center for Healthcare Communication Research to develop the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) algorithm which is delivered via My GI Health, an open--source Internet based patient-provider portal (P3) designed to enhance the delivery of GI health care (www.MyGIHealth.org). Through My GI Health and AEGIS, patients are able to complete PROMIS GI symptom measures and provide additional information about their GI symptoms and histories from computers, tablets or smart phones without the constraints of physical locale. This information is condensed into a GI PROMIS scores report and initial GI history that patients' providers can review prior to or concurrent with seeing the patient. The report, which can be incorporated into the electronic health record (EHR), helps busy clinicians to quickly understand the patient's complaints, document their symptoms and GI history, and leaves more time for conversation with the patient. Beyond focusing their interaction, My GI Health also supports both the clinician and patient with an individualized "educational prescription" which guides the patient through a library of multi-media educational materials on GI symptoms, conditions, and treatments also contained within the website. The prescription is initially created by the website based o
Conditions Studied
Interventions
- OTHER AEGIS (Automated Evaluation of Gastrointestinal Symptoms)
Study Locations (3)
California
- Cedars-Sinai Medical Center — Los Angeles
- West Los Angeles VA Medical Center — Los Angeles
Michigan
- University of Michigan — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02436057
The ClinicalTrials.gov registry entry for NCT02436057 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 255 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 360 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Constipation appearing as the primary indexed condition, and to 1 intervention — of which AEGIS (Automated Evaluation of Gastrointestinal Symptoms) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02436057 reports 3 study locations spanning 2 distinct geographic areas — top geographies include California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02436057 about?
NCT02436057 is a clinical study titled "Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) Platform". Through a four-year grant awarded to the University of California at Los Angeles in 2009, Dr. Brennan Spiegel served as a principal investigator (PI) for a project to develop and initially validate a bank of items to assess gastrointestinal (GI) symptoms for the National Institutes of Health's (NIH'...
What is the current status of trial NCT02436057?
This trial is currently completed. It is a NA study. The enrollment target is 255 participants. The study started on 2014-07. Estimated completion is 2015-12.
What conditions does trial NCT02436057 study?
This clinical trial studies the following conditions: Constipation, Gastroesophageal Reflux, Diarrhea, Fecal Incontinence, Abdominal Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02436057?
The interventions under investigation include: AEGIS (Automated Evaluation of Gastrointestinal Symptoms) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02436057?
This trial is sponsored by Cedars-Sinai Medical Center, which has 360 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02436057 being conducted?
This trial has 3 study locations across California, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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