Medical Illustration Design Characteristic Evaluation

Healthy Clinical Trial

Official title:

Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 1: Medical Illustration Design Characteristic Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435806
• Other study ID #: 427440
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: May 2024
• Source: Northeastern University
• Contact: Timothy Bickmore, PhD
• Phone: 6173735477
• Email: t.bickmore[@]northeastern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to understand what people understand from medical illustrations, and what meaning and emotions (such as anxiety) they derive from different design elements.

Description:

The investigators will conduct cognitive interviews to understand the meaning laypersons obtain from different illustrations, their opinions on illustration styles, and their level of anxiety after viewing illustrations. The investigators will also study the effect of systematically varying medical illustration designs on layperson understanding and anxiety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8200
• Est. completion date: January 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old
• Speaks English or Spanish ?uently
• Is able to independently consent
• Has adequate corrected vision to read patient education documents

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Medical Illustration design
We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.

Locations

Country	Name	City	State
United States	Northeastern University	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Northeastern University	Boston University, Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge	A multiple-item knowledge test designed to test comprehension of the patient education document	Baseline and 30 minutes
Primary	State Anxiety scale from State-Trait Anxiety Inventory	Self-report state anxiety scale from the State-Trait Anxiety Inventory. 20 items, 4-point Likert scale. A higher score indicates more severe anxiety with a potential range from 20 to 80.	30 minutes
Secondary	Satisfaction with the medical illustration	Likert items to assess satisfaction with the document and illustration	30 minutes
Secondary	Reading Effort	Likert items to assess perceived effort in reading a document and illustration	30 minutes
Secondary	Acceptability	Likert items to assess acceptability and appropriateness of the illustration	30 minutes