Pharmacogenomic Testing Of the Elderly To Reduce Morbidity
- Conditions
- Genetics of Drug Metabolism
- Registration Number
- NCT02095769
- Lead Sponsor
- General Genetics Corporation
- Brief Summary
The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits.
The way an individual processes or metabolizes a drug is in part determined by their genes, and there is known to be genetic variation from one human to another. The study of the way in which genes affect an individual's response to drugs is known as "Pharmacogenomics."
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 280000
- Subject underwent PGx testing for the alleles appropriate to the target drugs within the prior 90 days ('index PGx test')
- Males and females aged ≥65 years or male and females aged ≥18 years who have a disability
- Subject is able and willing to provide written informed consent
- Subject was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test, including over-the-counter medications
- Subject has a history of at least one target drug-related adverse event (TDAE) over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug
- Subject is currently hospitalized
- Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx test results
- Subject is unable to provide an accurate history due to mental incapacity
- Subject is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Registry
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of Meaningful Change in Drug Regimen 90 days The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when:
1. A genotype known to affect a drug the subject is taking is identified, and
2. The subject's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation.
- Secondary Outcome Measures
Name Time Method Binary occurrence of meaningful change in drug regimen, defined at the gene level over the 90-day period following receipt of PGx test results 90 days Binary occurrence of whether, in the Investigator's opinion, the subject experienced clinical benefit from drug regimen changes made as a result of the PGx test 90 days Clinical benefit refers to improvement in the subject's condition in the Investigator's opinion
Number of changes in a subject's target drugs, tabulated on a per-subject basis by number and percentage of target drugs and total drugs 90 days Binary change (yes/no) in the regimen of drugs controlled by genes of interest over the 90-day period preceding PGx testing compared with the change (yes/no) over the 90-day period following receipt of PGx test results 90 days Number of target drug-related adverse events over the 90-day period prior to and following PGx testing 90 days Emergency department visits over the 90-day periods prior to and following PGx testing 90 days Binary occurrence of meaningful change in drug regimen, defined at the drug level over the 90-day period following receipt of PGx test results 90 days Hospitalizations over the 90-day period prior to and following receipt of PGx test results 90 days
Trial Locations
- Locations (8)
Core Insitute
🇺🇸Phoenix, Arizona, United States
The International Heart & Lung Institute Center for Restorative Medicine
🇺🇸Palm Springs, California, United States
Research Physicians Network Alliance
🇺🇸Pembroke Pines, Florida, United States
Tallahassee Neurological Institute
🇺🇸Tallahassee, Florida, United States
Hypertension Institute
🇺🇸Nashville, Tennessee, United States
Research & Cardiovascular Corp.
🇵🇷Ponce, Puerto Rico
Diagnostic Clinic of Houston
🇺🇸Houston, Texas, United States
LifeSpan Institute
🇺🇸La Jolla, California, United States