Using Visual Arrays to Support Understanding of Genetic Risk

March 25, 2025 updated by: Andrew Dwyer, Boston College

Examining Genetic Literacy and Numeracy in the General Population

The goal of this study is to understand how people understand risk from genetic testing. The investigators want to understand what visual aid best helps people accurately assess risk. The investigators also want to understand how people relate risk to their health. The main questions the study aims to answer are:

  1. Which visual aid most accurately show genetic risk?
  2. How do people perceive risk related to genetic test results?
  3. What factors are associated with people discussing their results with family?

Participants will:

  1. receive of of two visual aids showing risk
  2. state their estimation of risk
  3. answer questions about how they feel about risk and sharing information with family

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine how visual aids help people most accurately interpret risk from genetic test results. The study also examines how people perceive risk by drawing on the Tripartite Risk Model. Last, the study examines factors that are associated with intention to share genetic test results with family members.

Participants will provide brief sociodemographic information, complete brief health literacy and numeracy assessments, and questions about how they perceive risk. Participants will be informed of a genetic testing scenario and will receive one of two visual aids. After reviewing the visual aid, participants will state the risk shown in the visual aid and will answer questions about their perceived risk and sharing results with family members (blood relatives).

Study Type

Interventional

Enrollment (Estimated)

1200

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

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:

  • ability to read and understand English
  • opt-in consent

Exclusion Criteria:

  • incorrect responses to validation questions

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Visual Array
Single, side-by-side visual array
Behavioral: Visual Array
Single side-by-side visual array
Other: Narrative Visual Array
Evolving narrative showing sequential visual arrays
Behavioral: Narrative Visual Array
Evolving narrative with sequential visual arrays

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk Accuracy
Time Frame: immediately after the intervention
closest approximation to risk percentage depicted in the visual array
immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk Perceptions
Time Frame: immediately after the intervention
Perceptions based on the Tripartite Risk Model
immediately after the intervention
Communication intent
Time Frame: immediately after the intervention
Intent to communicate risk to blood relatives
immediately after the intervention

Collaborators and Investigators

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

Sponsor

Boston College

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Massachusetts General Hospital

Investigators

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

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 (Estimated)

April 1, 2025

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5111381
  • P50HD104224 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data will be shared via the HarvardDataverse platform.

IPD Sharing Time Frame

Start date: within one month of the publication of study results. End date: one year after posting

IPD Sharing Access Criteria

HarvardDataverse platform

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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