The Texas Interprofessional Pharmacogenomics Registry and Repository
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Frequency and nature of ADRs on the Naranjo Scale
研究概览
简要总结
This program collects genetic and health information to help doctors choose the right medications for patients.
详细描述
This study wants to understand how genes can affect how the body responds to medicines. This information will help us determine whether changing your medicine can make you healthier and improve your life. We will study your medical history for the last year and the next five years after you join the study.
study goals include:
- Enrolling patients who take multiple medications or have harmful side effects from their medications.
- Keeping all medical information and genetic samples from patients in one place.
- Helping doctors make better decisions about which medicines to prescribe.
- Influencing insurance companies and the government to help pay for this kind of medical care for people who need to change their medicine to stay healthy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will invite patients who are eligible for PGX workup/PGX care to participate, provided they meet the following criteria: Use of five or more medications, including over the counter drugs, supplements, natural products, cannabis products, or other recreational drugs, or
- •Individuals taking blood pressure or depression medications, even if less than five medications.
- •Ability to understand and give consent.
- •Able to consent to donate blood and/or urine samples and buccal swabs.
- •Able to answer detailed questionnaires, including quarterly questionnaires about ADRs, cognitive testing such as serial mini-mental status exams, and or quality of life questions.
- •Able to understand that their health record and changes in health status will be followed for a five-year period and shared in deidentified form with the research community.
- •All genders.
- •Any age over 18 years.
排除标准
- •Individuals admitted to hospice.
- •Declines to participate or interact with staff/share their medical status.
- •A diagnosis of Alzheimer's disease or related dementias in a medical record as this indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning.,
- •Individuals who are unable or unwilling to provide consent.
- •Unable to verbally communicate and comprehend English language
结局指标
主要结局
Frequency and nature of ADRs on the Naranjo Scale
时间窗: 5 years
Patients will be referred to the Texas A\&M Interprofessional Pharmacogenomics Clinic (IPGx) by their primary care physicians. A physician or ambulatory pharmacist in the IPGx clinic or Family Care Clinic will obtain a complete medical history, physical examination, and validate the patient's current concomitant medication list at the IPGx during the office visit. Patient medical information would be input into the CSN, which functions as a computable EHR medical record analysis, evaluation of polypharmacy status, and monitoring of Adverse Drug Reactions using the Naranjo Scale questionnaire will be conducted for the duration of the study.
次要结局
- Serum/plasma drug concentrations(5 years)