- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04889014
Efficacy of Personal Pharmacogenomic Testing as an Educational Tool in the Pharmacy Curriculum
May 11, 2021 updated by: University of Arizona
The purpose of this study is to evaluate the use of personal genomic educational testing (PGET) on student knowledge and clinical skills surrounding pharmacogenomic testing to ensure it is of educational benefit to our student population.
Students will be provided the opportunity to opt-in to test their own pharmacogenomic panel while participating in the standard curriculum.
Students will have the option of using their own reports or dummy reports during classroom activities.
Our hypothesis is that those students who have their own pharmacogenomics tested will show better overall performance.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
233
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Willingness to provide informed consent for participation in the study
- Enrolled in 3rd year Doctor of Pharmacy course
Exclusion Criteria:
- Unwilling or unable to provide consent for participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Personal genomic educational testing (PGET)
PGET group participants received their own pharmacogenomic testing results prior to the course modules covering material tested in the knowledge assessment
|
PGET consisted of a panel of pharmacogenomic variants
|
|
Placebo Comparator: No personal genomic educational testing (NPGET)
No PGET (NPGET) group participants did not receive their own pharmacogenomic testing results until after study completion.
|
Lack of pharmacogenomic testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pharmacogenomics Knowledge Assessment
Time Frame: 8-12 weeks
|
Improvement in performance on a knowledge assessment including eleven questions
|
8-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Self Assessment Questionnaire
Time Frame: 8-12 weeks
|
Improvement in Likert Scale Responses for 27 questions (scale of 1[worst] to 6[best])
|
8-12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2016
Primary Completion (Actual)
March 1, 2021
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
May 4, 2021
First Submitted That Met QC Criteria
May 11, 2021
First Posted (Actual)
May 17, 2021
Study Record Updates
Last Update Posted (Actual)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 11, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 1602413309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.