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Educational Video for Pharmacogenomics (MPRINT Trial)

N/A

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pediatric: Aged 0 to 16

Pediatric: Have a chronic health condition.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post-return of pgx results, approximately 2-4 weeks

Awards & highlights

MPRINT Trial Summary

This trial is looking at whether an educational video about pharmacogenetic testing impacts people's knowledge and attitudes around the testing.

Who is the study for?

This trial is for English or Spanish-speaking adult women who are 12 to 30 weeks pregnant, receiving care at VUMC, and planning to deliver there. They must consent to pharmacogenomic testing and allow access to their medical records. Women with recent transfusions, prior genetic testing, or those using assisted reproductive technologies can't participate.Check my eligibility

What is being tested?

The study aims to understand how children and pregnant women think about genetic tests that predict drug reactions (pharmacogenetics). It involves watching an educational video on this topic either when getting test results or later on. The impact of the video on knowledge and attitudes will be measured through surveys.See study design

What are the potential side effects?

Since the intervention in this study is an educational video, there are no direct physical side effects associated with it. However, learning about pharmacogenetic testing could potentially cause emotional or psychological responses.

MPRINT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 16 years old or younger.

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I am a child with a long-term health issue.

MPRINT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to post-return of pgx results, approximately 2-4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to post-return of pgx results, approximately 2-4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post-return of pgx results, approximately 2-4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participants' opinions of pharmacogenetic testing changes after results are received

Secondary outcome measures

Participants gain an improved knowledge of pharmacogenetics after educational intervention

Researchers gain a better understanding of the concerns about and perceptions of pharmacogenetic testing among pregnant women and parents of children with chronic conditions

MPRINT Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention armExperimental Treatment1 Intervention

All individuals in the Intervention arm will undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenomic assay used at Vanderbilt University Medical Center. Upon completion of the testing, they will be provided a link to an educational video about pharmacogenetic testing and results. Surveys will be performed before and after the pharmacogenetic testing.

Group II: Delayed intervention armExperimental Treatment1 Intervention

All individuals in the Delayed intervention arm will undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenomic assay used at Vanderbilt University Medical Center. Surveys will be performed before and after the pharmacogenetic testing. Upon completion of the first follow up survey, they will be provided a link to an educational video about pharmacogenetic testing and results. A second follow up survey will then be completed.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

671,693 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this research study?

"Affirmative, current information available on clinicaltrials.gov reveals that this research study began recruiting patients upon its June 30th 2022 posting date and is still ongoing—last updated November 4th of the same year. To meet their desired cohort size, 500 participants across two sites are needed to take part in the trial's investigations."

Answered by AI

Are fresh participants being accepted for this research endeavor at present?

"According to the clinicaltrials.gov portal, this study is actively searching for participants and was initially posted on June 30th 2022 with a recent update of November 4th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey

Digna Velez Edwards 2022. "VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05037305.