PainREVOLUTIONNCT02487888
A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care
A study testing Unblinded to Genetic Testing Results and Blinded to Genetic Testing Results in people with Pain and Chronic Pain, run by Proove Bioscience, Inc. at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Pain, Mental Disorders
- What is being tested?
- Unblinded to Genetic Testing Results and Blinded to Genetic Testing Results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- 31 sitesUnited States
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Lighthouse Medical
Altoona, Pennsylvania, 16601
Interventional Pain Institute
Baltimore, Maryland, 21224
Medical Clinic - Amy Weinberg M.D. Inc
Beverly Hills, California, 90211
Medical Clinic - Dr. Neil Ghodadra
Beverly Hills, California, 90212
Snibbe Orthopedics
Beverly Hills, California, 90212
Medical Clinic - Dr. Kevin Monahan, MD
Boca Raton, Florida, 33428
Personal Medicine, LLC
Chattanooga, Tennessee, 37416-166
Associates MD
Davie, Florida, 33328
Reeders Internal Medicine
Fort Lauderdale, Florida, 33316
Troutt & Associates, PSC
Fort Lauderdale, Florida, 33316
Medical Clinic - Kevin Ohayon MD Family Medicine
Fort Lauderdale, Florida, 33334
Comprehensive Pain Clinic
Fort Wayne, Indiana, 46825
Robert Graham, MD
Fresno, California, 93710
Bautista Medical Group
Fresno, California, 93726
Medical Clinic - Anthony Mathis, DPM
Greer, South Carolina, 29651
Northgate Neurology
Hixson, Tennessee, 37343
Torrey Pines Orthopaedic Medical Group
La Jolla, California, 92037
New England Center for Mental Health
Littleton, Massachusetts, 01460
Soha Dolatabadi Rheumatology
Los Angeles, California, 90017
Medical Clinic - Dr. Rosenberg A. Reyes
Louisville, Kentucky, 40214
Neurology of Central Georgia
Macon, Georgia, 31210
Morristown Pain Consultants
Morristown, Tennessee, 37813
Summit Family Medicine
Murrieta, California, 92563
Mallik Tella MD
Portland, Oregon, 97216
Macer Medical
Rolling Hills, California, 90274
Medical Clinic - Paul C. Murphy, MD Inc
San Diego, California, 92122
Idaho Pain Clinic
Sandpoint, Idaho, 83864
Pain Clinic of Spokane
Spokane, Washington, 99006
Comprehensive Pain Relief Group
Torrance, California, 90501
Orthopedic Associates of SW Ohio
Vandalia, Ohio, 45414
The Doctor's Office
Vista, California, 92083
About this study
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
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.
Read the 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.
- Conditions
- Pain, Chronic Pain, Mental Disorders, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Arthritis
- Being tested
- Unblinded to Genetic Testing Results, Blinded to Genetic Testing Results
- Keywords
- Genetic Variation, Genetic Polymorphism, Polymorphism, Single Nucleotide, Genetic Association Studies, Healthcare Utilization
- Medical subject headings
- Pain, Chronic Pain, Mental Disorders, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unblinded to Genetic Testing ResultsOther
The physicians of this group of patients will be unblinded to the results of the genetic testing.
Blinded to Genetic Testing ResultsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain | Experimental | Patients presenting to a clinic for pain, that will be either blinded to genetic testing results or unblinded to genetic testing results Receives: Other: Unblinded to Genetic Testing Results; Other: Blinded to Genetic Testing Results |
| Mental Health | Experimental | Patients presenting to a clinic for mental health disorders, that will be either blinded to genetic testing results or unblinded to genetic testing results Receives: Other: Unblinded to Genetic Testing Results; Other: Blinded to Genetic Testing Results |
| Cardiovascular | Experimental | Patients presenting to a clinic for cardiovascular complications, that will be either blinded to genetic testing results or unblinded to genetic testing results Receives: Other: Unblinded to Genetic Testing Results; Other: Blinded to Genetic Testing Results |
| Arthritis | Experimental | 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 Receives: Other: Unblinded to Genetic Testing Results; Other: Blinded to Genetic Testing Results |
| Type 2 Diabetes Mellitus | Experimental | Patients presenting to a clinic for T2DM, that will be either blinded to genetic testing results or unblinded to genetic testing results Receives: Other: Unblinded to Genetic Testing Results; Other: Blinded to Genetic Testing Results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Pain Numeric Rating Scale (NRS)
Measured: 60 days
Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: 60 days
Number of Participants that Experience of Adverse Events
Measured: Up to 2 years
Type of Adverse Events Experienced by Participants
Measured: Up to 2 years
Severity of Adverse Events Experienced by Participants
Measured: Up to 2 years
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
Measured: Up to 2 years
Medication dosage prescribed to the participants
Measured: Up to 2 years
Frequency of participant urine drug screens
Measured: Up to 2 years
Self-rated response levels to prescribed medications
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.
Measured: 60 days
Presence and Severity of Generalized Anxiety Disorder on the GAD-2
Measured: 60 days
Presence and Severity of Depression on the PHQ-2
Measured: 60 days
Presence of atrial fibrillation symptoms and their impact on quality of life using the Severity of Atrial Fibrillation (SAF) scale
Measured: 60 days
Risk of cardiovascular incidents using the AHA Heart Disease Risk Assessment
Measured: 60 days
Risk of stroke using the CHA2DS2-VASc Score
Measured: 60 days
Severity of Rheumatoid Arthritis using the Routine Assessment of Patient Index Data (RAPID-3) score
Measured: 60 days
BMI for patients being treated for T2DM
Measured: 60 days
Glucose levels for patients being treated for T2DM
Measured: 60 days
Secondary outcomes (3)
Co-occurring disorders collected by ICD-9/10 codes
Measured: 60 days
Assessment of previous treatments
Participants are asked to rate the benefit of previous treatments on a scale of 0 to 5.
Measured: 60 days
Urine drug screen results
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proove Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory A Smith, M.D., Principal investigator, G.S. Medical Center Inc./Comprehensive Pain Relief Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487888
- Sponsor's protocol ID
- PB008
- Acronym
- REVOLUTION
- Status last verified
- Mar 2016
- First submitted
- 26 Jun 2015
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02487888
- Acronym / sponsor ID
- REVOLUTION / PB008
- Conditions
- Pain, Chronic Pain, Mental Disorders, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Arthritis
- Keywords
- Genetic Variation, Genetic Polymorphism, Polymorphism, Single Nucleotide, Genetic Association Studies, Healthcare Utilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Proove Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pain | Experimental | Other: Unblinded to Genetic Testing Results, Other: Blinded to Genetic Testing ResultsPatients presenting to a clinic for pain, that will be either blinded to genetic testing results or unblinded to genetic testing results |
| Mental Health | Experimental | Other: Unblinded to Genetic Testing Results, Other: Blinded to Genetic Testing ResultsPatients presenting to a clinic for mental health disorders, that will be either blinded to genetic testing results or unblinded to genetic testing results |
| Cardiovascular | Experimental | Other: Unblinded to Genetic Testing Results, Other: Blinded to Genetic Testing ResultsPatients presenting to a clinic for cardiovascular complications, that will be either blinded to genetic testing results or unblinded to genetic testing results |
| Arthritis | Experimental | Other: Unblinded to Genetic Testing Results, Other: Blinded to Genetic Testing ResultsPatients presenting to a clinic for osteoarthritis or rheumatoid arthritis, that will be either blinded to genetic testing results or unblinded to genetic testing results |
| Type 2 Diabetes Mellitus | Experimental | Other: Unblinded to Genetic Testing Results, Other: Blinded to Genetic Testing ResultsPatients presenting to a clinic for T2DM, that will be either blinded to genetic testing results or unblinded to genetic testing results |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unblinded to Genetic Testing ResultsThe physicians of this group of patients will be unblinded to the results of the genetic testing. | Other | Arthritis, Cardiovascular, Mental Health, Pain, Type 2 Diabetes Mellitus |
| Blinded to Genetic Testing ResultsThe 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. | Other | Arthritis, Cardiovascular, Mental Health, Pain, Type 2 Diabetes Mellitus |
Primary outcome
Pain Scores on the Pain Numeric Rating Scale (NRS)
Time frame: 60 days
Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 60 days
Number of Participants that Experience of Adverse Events
Time frame: Up to 2 years
Type of Adverse Events Experienced by Participants
Time frame: Up to 2 years
Severity of Adverse Events Experienced by Participants
Time frame: Up to 2 years
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
Medication dosage prescribed to the participants
Time frame: Up to 2 years
Frequency of participant urine drug screens
Time frame: Up to 2 years
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.
Presence and Severity of Generalized Anxiety Disorder on the GAD-2
Time frame: 60 days
Presence and Severity of Depression on the PHQ-2
Time frame: 60 days
Presence of atrial fibrillation symptoms and their impact on quality of life using the Severity of Atrial Fibrillation (SAF) scale
Time frame: 60 days
Risk of cardiovascular incidents using the AHA Heart Disease Risk Assessment
Time frame: 60 days
Risk of stroke using the CHA2DS2-VASc Score
Time frame: 60 days
Severity of Rheumatoid Arthritis using the Routine Assessment of Patient Index Data (RAPID-3) score
Time frame: 60 days
BMI for patients being treated for T2DM
Time frame: 60 days
Glucose levels for patients being treated for T2DM
Time frame: 60 days
3 secondary outcomes
Co-occurring disorders collected by ICD-9/10 codes
Time frame: 60 days
Assessment of previous treatments
Time frame: 60 days
Urine drug screen results
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A Smith, M.D. principal investigator
G.S. Medical Center Inc./Comprehensive Pain Relief Group
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unblinded to Genetic Testing Results and Blinded to Genetic Testing Results in people with Pain and Chronic Pain, run by Proove Bioscience, Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores on the Pain Numeric Rating Scale (NRS) (time frame: 60 days). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.