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A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care (REVOLUTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02487888
Recruitment Status : Unknown
Verified March 2016 by Proove Bioscience, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : July 2, 2015
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Proove Bioscience, Inc.

Brief Summary:
The purpose of this study is to evaluate the impact of genetic testing on healthcare decisions and patient outcomes for patients suffering from pain, cardiovascular problems, Arthritis, Type II Diabetes, and/or Mental Health disorders. Results of genetic testing will also be compared with the clinical outcome measures collected to discover novel genetic factors that may influence patient care.

Condition or disease Intervention/treatment Phase
Pain Chronic Pain Mental Disorders Cardiovascular Diseases Diabetes Mellitus, Type 2 Arthritis Other: Unblinded to Genetic Testing Results Other: Blinded to Genetic Testing Results Not Applicable

Detailed Description:

The molecular basis of many pharmacogenetic polymorphisms has now been elucidated, with genetic variations resulting in alteration of expression or function of receptors, enzymes, and transporters relevant to the safety and efficacy of a medical treatment. Genetics has been shown to be a significant factor in the variability of responses of medication choices and doses. With the rapid development of cost-effective high throughput molecular genotyping methods, pharmacogenetics has become increasingly important because of its potential to identify patients with increased risk of adverse drug reactions or decreased likelihood of response at standard dosage of drug. By identifying the genetic risks and the most effective therapy for an individual patient, clinicians may improve the efficacy of treatment and decrease the risk of adverse drug events. The addition of pharmacogenetic testing to routine clinical practice may also be extremely helpful because of the cost reduction associated with the identification of patients that will not respond to expensive drugs or with the identification of patients likely to suffer from severe adverse events. There are also tremendous efforts in the pharmaceutical industry to lower the cost for drug development; pharmacogenetics may fulfill the need to provide the right drug to the right patient and to increase the likelihood of success of large phase II and phase III clinical trials.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized, Blinded, Controlled Trial to EValuate the EcOnomic and ClinicaL Outcomes of Utilizing Genetic Testing to Improve Therapeutic Decision-Making COmpared to Empiric Prescribing as the StaNdard of Care
Study Start Date : September 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arm Intervention/treatment
Experimental: Pain
Patients presenting to a clinic for pain, that will be either blinded to genetic testing results or unblinded to genetic testing results
Other: Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.

Other: 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.

Experimental: 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
Other: Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.

Other: 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.

Experimental: Cardiovascular
Patients presenting to a clinic for cardiovascular complications, that will be either blinded to genetic testing results or unblinded to genetic testing results
Other: Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.

Other: 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.

Experimental: 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
Other: Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.

Other: 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.

Experimental: 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
Other: Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.

Other: 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.




Primary Outcome Measures :
  1. Pain Scores on the Pain Numeric Rating Scale (NRS) [ Time Frame: 60 days ]
  2. Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 60 days ]
  3. Number of Participants that Experience of Adverse Events [ Time Frame: Up to 2 years ]
  4. Type of Adverse Events Experienced by Participants [ Time Frame: Up to 2 years ]
  5. Severity of Adverse Events Experienced by Participants [ Time Frame: Up to 2 years ]
  6. Type of medication or alternative therapy prescribed for participants, as listed on the Medication Efficacy Differentiation (MED) Scale or on the investigator's evaluation form [ Time Frame: Up to 2 years ]
  7. Medication dosage prescribed to the participants [ Time Frame: Up to 2 years ]
  8. Frequency of participant urine drug screens [ Time Frame: Up to 2 years ]
  9. Self-rated response levels to prescribed medications [ Time Frame: 60 days ]
    Subjects are ask to rate the ability of their medication, on a scale of 0 to 5, to treat their condition and/or relieve their symptoms.

  10. Presence and Severity of Generalized Anxiety Disorder on the GAD-2 [ Time Frame: 60 days ]
  11. Presence and Severity of Depression on the PHQ-2 [ Time Frame: 60 days ]
  12. Presence of atrial fibrillation symptoms and their impact on quality of life using the Severity of Atrial Fibrillation (SAF) scale [ Time Frame: 60 days ]
  13. Risk of cardiovascular incidents using the AHA Heart Disease Risk Assessment [ Time Frame: 60 days ]
  14. Risk of stroke using the CHA2DS2-VASc Score [ Time Frame: 60 days ]
  15. Severity of Rheumatoid Arthritis using the Routine Assessment of Patient Index Data (RAPID-3) score [ Time Frame: 60 days ]
  16. BMI for patients being treated for T2DM [ Time Frame: 60 days ]
  17. Glucose levels for patients being treated for T2DM [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Co-occurring disorders collected by ICD-9/10 codes [ Time Frame: 60 days ]
  2. Assessment of previous treatments [ Time Frame: 60 days ]
    Participants are asked to rate the benefit of previous treatments on a scale of 0 to 5.

  3. Urine drug screen results [ Time Frame: 60 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide signed and dated informed consent form
  • 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:

  • Severe hepatic or renal disease (where current pharmaceutical dosing is affected and/or requires adjustment of standard dosing prior to PGx testing)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487888


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Sponsors and Collaborators
Proove Bioscience, Inc.
Investigators
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Principal Investigator: Gregory A Smith, M.D. G.S. Medical Center Inc./Comprehensive Pain Relief Group

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Responsible Party: Proove Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT02487888     History of Changes
Other Study ID Numbers: PB008
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Keywords provided by Proove Bioscience, Inc.:
Genetic Variation
Genetic Polymorphism
Polymorphism, Single Nucleotide
Genetic Association Studies
Healthcare Utilization
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Chronic Pain
Mental Disorders
Cardiovascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases