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Pilot of Preemptive Pharmacogenetics in Medically Underserved Patients

NCT04630093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-10-04

Study results available
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Summary

This is a pragmatic clinical trial of 100 patients who self-identify as black or Latino. Patients with active prescriptions for at least 3 medications and a medication change within the past 6-months will be recruited from the University of Florida (UF) Health primary care clinics for panel-based pharmacogenetic testing. Participants will be followed for 6 months and will undergo assessments with the Treatment Satisfaction Questionnaire for Medication (TSQM) three times (baseline visit, 3-month visit, and 6-month visit post pharmacogenetic testing). In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the electronic health record (EHR) and patient report. Participation is expected to last approximately 6 months and the study will be open for approximately 12-14 months.

Conditions

  • Pharmacogenetic Testing

Interventions

DIAGNOSTIC_TEST

Panel-based pharmacogenetic genotyping

A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Julio Duarte, PharmD, PhD · University of Florida

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-13
Primary Completion
2022-06-22
Completion
2022-06-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630093 on ClinicalTrials.gov