A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care
NCT ID: NCT02487888
Last Updated: 2016-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100000 participants
INTERVENTIONAL
2014-09-30
2016-12-31
Brief Summary
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Detailed Description
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The purpose of this study is to evaluate how currently available genetic tests are being implemented in various clinics around the United States, and whether this information results in benefits to patient care. Patients presenting to clinics with pain, cardiovascular conditions, Arthritis, Type II Diabetes, and/or Mental Health disorders that are receiving Proove Bioscience's genetic testing will complete validated questionnaires to measure specific outcomes related to their treatment at each clinical visit, including medication efficacy, reduction in adverse drug events, and healthcare utilization. Physicians will document any changes made to treatment regimens, including adjustments to medications or non-pharmacological treatments, and any improvements in the outcome measures. Statistical analysis will be performed to calculate relationships between genotypic and phenotypic data points collected in this study.
The results of this study will provide a measurable understanding of the medical and economic value of implementing genetic testing into clinical care. Furthermore, data points collected will be used to examine novel correlations and associations between single nucleotide polymorphisms and longitudinal clinical outcome measures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Pain
Patients presenting to a clinic for pain, that will be either blinded to genetic testing results or unblinded to genetic testing results
Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
Blinded to Genetic Testing Results
The physicians of this group of patients will be blinded to the results of the genetic testing. They will be un-blinded to the results of each patient once that patient has completed the study.
Mental Health
Patients presenting to a clinic for mental health disorders, that will be either blinded to genetic testing results or unblinded to genetic testing results
Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
Blinded to Genetic Testing Results
The physicians of this group of patients will be blinded to the results of the genetic testing. They will be un-blinded to the results of each patient once that patient has completed the study.
Cardiovascular
Patients presenting to a clinic for cardiovascular complications, that will be either blinded to genetic testing results or unblinded to genetic testing results
Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
Blinded to Genetic Testing Results
The physicians of this group of patients will be blinded to the results of the genetic testing. They will be un-blinded to the results of each patient once that patient has completed the study.
Arthritis
Patients presenting to a clinic for osteoarthritis or rheumatoid arthritis, that will be either blinded to genetic testing results or unblinded to genetic testing results
Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
Blinded to Genetic Testing Results
The physicians of this group of patients will be blinded to the results of the genetic testing. They will be un-blinded to the results of each patient once that patient has completed the study.
Type 2 Diabetes Mellitus
Patients presenting to a clinic for T2DM, that will be either blinded to genetic testing results or unblinded to genetic testing results
Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
Blinded to Genetic Testing Results
The physicians of this group of patients will be blinded to the results of the genetic testing. They will be un-blinded to the results of each patient once that patient has completed the study.
Interventions
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Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
Blinded to Genetic Testing Results
The physicians of this group of patients will be blinded to the results of the genetic testing. They will be un-blinded to the results of each patient once that patient has completed the study.
Eligibility Criteria
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Inclusion Criteria
* Willing to comply with all study procedures and be available for the duration of the study
* Male or Female, at least 18 years of age
* Currently taking or a candidate for medication
* Documented or recent complaint within 90 days with initial date of onset
Exclusion Criteria
* Significant diminished mental capacity that is unable to understand the protocol, surveys and questionnaires; unable to read/write English or Spanish.
* Recent febrile illness that precludes or delays participation by more than 1 month
* Pregnancy or lactation
* Participation in a clinical study that may interfere with participation in this study
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
18 Years
ALL
No
Sponsors
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Proove Bioscience, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory A Smith, M.D.
Role: PRINCIPAL_INVESTIGATOR
G.S. Medical Center Inc./Comprehensive Pain Relief Group
Locations
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Medical Clinic - Amy Weinberg M.D. Inc
Beverly Hills, California, United States
Medical Clinic - Dr. Neil Ghodadra
Beverly Hills, California, United States
Snibbe Orthopedics
Beverly Hills, California, United States
Robert Graham, MD
Fresno, California, United States
Bautista Medical Group
Fresno, California, United States
Torrey Pines Orthopaedic Medical Group
La Jolla, California, United States
Soha Dolatabadi Rheumatology
Los Angeles, California, United States
Summit Family Medicine
Murrieta, California, United States
Macer Medical
Rolling Hills, California, United States
Medical Clinic - Paul C. Murphy, MD Inc
San Diego, California, United States
Comprehensive Pain Relief Group
Torrance, California, United States
The Doctor's Office
Vista, California, United States
Medical Clinic - Dr. Kevin Monahan, MD
Boca Raton, Florida, United States
Associates MD
Davie, Florida, United States
Reeders Internal Medicine
Fort Lauderdale, Florida, United States
Troutt & Associates, PSC
Fort Lauderdale, Florida, United States
Medical Clinic - Kevin Ohayon MD Family Medicine
Fort Lauderdale, Florida, United States
Neurology of Central Georgia
Macon, Georgia, United States
Idaho Pain Clinic
Sandpoint, Idaho, United States
Comprehensive Pain Clinic
Fort Wayne, Indiana, United States
Medical Clinic - Dr. Rosenberg A. Reyes
Louisville, Kentucky, United States
Interventional Pain Institute
Baltimore, Maryland, United States
New England Center for Mental Health
Littleton, Massachusetts, United States
Orthopedic Associates of SW Ohio
Vandalia, Ohio, United States
Mallik Tella MD
Portland, Oregon, United States
Lighthouse Medical
Altoona, Pennsylvania, United States
Medical Clinic - Anthony Mathis, DPM
Greer, South Carolina, United States
Personal Medicine, LLC
Chattanooga, Tennessee, United States
Northgate Neurology
Hixson, Tennessee, United States
Morristown Pain Consultants
Morristown, Tennessee, United States
Pain Clinic of Spokane
Spokane, Washington, United States
Countries
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Other Identifiers
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PB008
Identifier Type: -
Identifier Source: org_study_id
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