NCT02487888|Unknown

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

REVOLUTION

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

Proove Bioscience, Inc.ClinicalTrials.gov

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1 other identifier

PB008

Study Type

interventional

Target

100,000

Locations

1 country

Sites

Timeline

RegisteredJul 2015

StartedSep 2014

CompletionDec 2016

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

100,000

participants targeted

Target at P75+ for not_applicable pain

Timeline

Completed

Started Sep 2014

Typical duration for not_applicable pain

Geographic Reach

1 country

31 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

September 1, 2014

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed

6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed

Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

2.1 years

First QC Date

June 26, 2015

Last Update Submit

March 28, 2016

Conditions

Pain Chronic Pain Mental Disorders Cardiovascular Diseases Diabetes Mellitus, Type 2 Arthritis

Keywords

Genetic VariationGenetic PolymorphismPolymorphism, Single NucleotideGenetic Association StudiesHealthcare Utilization

Outcome Measures

Primary Outcomes (17)

Pain Scores on the Pain Numeric Rating Scale (NRS)
60 days
Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
60 days
Number of Participants that Experience of Adverse Events
Up to 2 years
Type of Adverse Events Experienced by Participants
Up to 2 years
Severity of Adverse Events Experienced by Participants
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
Up to 2 years
Medication dosage prescribed to the participants
Up to 2 years
Frequency of participant urine drug screens
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.
60 days
Presence and Severity of Generalized Anxiety Disorder on the GAD-2
60 days
Presence and Severity of Depression on the PHQ-2
60 days
Presence of atrial fibrillation symptoms and their impact on quality of life using the Severity of Atrial Fibrillation (SAF) scale
60 days
Risk of cardiovascular incidents using the AHA Heart Disease Risk Assessment
60 days
Risk of stroke using the CHA2DS2-VASc Score
60 days
Severity of Rheumatoid Arthritis using the Routine Assessment of Patient Index Data (RAPID-3) score
60 days
BMI for patients being treated for T2DM
60 days
Glucose levels for patients being treated for T2DM
60 days

Secondary Outcomes (3)

Co-occurring disorders collected by ICD-9/10 codes
60 days
Assessment of previous treatments
60 days
Urine drug screen results
60 days

Study Arms (5)

Pain

EXPERIMENTAL

Patients presenting to a clinic for pain, that will be either blinded to genetic testing results or unblinded to genetic testing results