HealthyNCT04889014
Efficacy of Personal Pharmacogenomic Testing as an Educational Tool in the Pharmacy Curriculum
A study testing Personal genomic educational testing (PGET) and No personal genomic educational testing (NPGET) in people with Healthy, run by University of Arizona.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Personal genomic educational testing (PGET) and No personal genomic educational testing (NPGET)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2016to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Willingness to provide informed consent for participation in the study
- Enrolled in 3rd year Doctor of Pharmacy course
Who cannot join
- Unwilling or unable to provide consent for participation
About this study
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.
- Conditions
- Healthy
- Being tested
- Personal genomic educational testing (PGET), No personal genomic educational testing (NPGET)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal genomic educational testing (PGET)Genetic
PGET consisted of a panel of pharmacogenomic variants
No personal genomic educational testing (NPGET)Genetic
Lack of pharmacogenomic testing
| Study group | Role | What they receive |
|---|---|---|
| Personal genomic educational testing (PGET) | Active comparator | PGET group participants received their own pharmacogenomic testing results prior to the course modules covering material tested in the knowledge assessment Receives: Genetic: Personal genomic educational testing (PGET) |
| No personal genomic educational testing (NPGET) | Placebo comparator | No PGET (NPGET) group participants did not receive their own pharmacogenomic testing results until after study completion. Receives: Genetic: No personal genomic educational testing (NPGET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pharmacogenomics Knowledge Assessment
Improvement in performance on a knowledge assessment including eleven questions
Measured: 8-12 weeks
Secondary outcomes (1)
Change in Self Assessment Questionnaire
Improvement in Likert Scale Responses for 27 questions (scale of 1[worst] to 6[best])
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start3 Mar 2016
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We investigated the effect of PGET on student knowledge, comfort, and attitudes related to pharmacogenomics (PGx) in a non-blinded, randomized controlled trial. Consenting participants were randomized to receive PGET or no PGET (NPGET) during four subsequent years of a PGx course.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889014
- Sponsor's protocol ID
- 1602413309
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Personal Pharmacogenomic Testing as an Educational Tool in the Pharmacy Curriculum
- ClinicalTrials.gov ID
- NCT04889014
- Acronym / sponsor ID
- 1602413309
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- We investigated the effect of PGET on student knowledge, comfort, and attitudes related to pharmacogenomics (PGx) in a non-blinded, randomized controlled trial. Consenting participants were randomized to receive PGET or no PGET (NPGET) during four subsequent years of a PGx course.
| Arm | Type | Receives |
|---|---|---|
| Personal genomic educational testing (PGET) | Active comparator | Genetic: 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 |
| No personal genomic educational testing (NPGET) | Placebo comparator | Genetic: No personal genomic educational testing (NPGET)No PGET (NPGET) group participants did not receive their own pharmacogenomic testing results until after study completion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Willingness to provide informed consent for participation in the study
- Enrolled in 3rd year Doctor of Pharmacy course
Key exclusion criteria (1 listed)
- Unwilling or unable to provide consent for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal genomic educational testing (PGET)PGET consisted of a panel of pharmacogenomic variants | Genetic | Personal genomic educational testing (PGET) |
| No personal genomic educational testing (NPGET)Lack of pharmacogenomic testing | Genetic | No personal genomic educational testing (NPGET) |
Primary outcome
Change in Pharmacogenomics Knowledge Assessment
Time frame: 8-12 weeks
Improvement in performance on a knowledge assessment including eleven questions
1 secondary outcome
Change in Self Assessment Questionnaire
Time frame: 8-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Personal genomic educational testing (PGET) and No personal genomic educational testing (NPGET) in people with Healthy, run by University of Arizona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pharmacogenomics Knowledge Assessment (time frame: 8-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.