Validating the Spanish "Attitudes Toward Genomics and Precision Medicine" (AGPM).

April 24, 2024 updated by: Boston College

Developing Culturally-Tailored Interventions to Overcome Genomic Health Disparities in Communities of Color

the investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino/a, or Latinx. Having a valid instrument is important for developing tailored interventions to decrease disparities in genomic healthcare for this population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

We will recruit 1,000 individuals (500 English-speaking and 500 Spanish-speaking) to complete the AGPM and previously validated instruments assessing health literacy and numeracy. Results will establish the psychometric properties of the Spanish version of the AGPM.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Recruiting
        • Boston College
        • Contact:
        • Sub-Investigator:
          • Maria Pineros-Leano, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • adult (18+ yrs.)
  • identifying as Hispanic, Latino/a, or Latinx
  • able to provide opt-in electronic informed consent

Exclusion Criteria:

  • under age 18 yrs.
  • not identifying as Hispanic, Latino/a, or Latinx
  • not able to provide opt-in electronic informed consent

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: AGPM for English Speakers
Participants identifying as Hispanic, Latino/a, or Latinx whose primary language is English
Other: Attitudes Toward Genomics and Precision Medicine (English)
completing the English version of the AGPM and validated health literacy and numeracy instruments
Other: AGPM for Spanish Speakers
Participants identifying as Hispanic, Latino/a, or Latinx whose primary language is Spanish
Other: Attitudes Toward Genomics and Precision Medicine (Spanish)
completing the Spanish version of the AGPM and validated health literacy and numeracy instruments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychometric properties
Time Frame: up to two weeks
Establish the psychometric properties of the translated AGPM
up to two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health literacy/numeracy
Time Frame: up to two weeks
Establish correlations between health literacy/numeracy and AGPM scores
up to two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston College

Investigators

  • Principal Investigator: Andrew A Dwyer, PhD, Boston College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 14, 2024

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24.210.01e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared with the developers of the AGPM

IPD Sharing Time Frame

Following publication, available indefinitely through the developers of the AGPM

IPD Sharing Access Criteria

Must contact the AGPM developers

IPD Sharing Supporting Information Type

  • ICF

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.

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