Medical Illustration Design Characteristic Evaluation
Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 1: Medical Illustration Design Characteristic Evaluation
1 other identifier
interventional
8,200
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Mar 2024
Longer than P75 for not_applicable healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2024
CompletedFirst Submitted
Initial submission to the registry
May 21, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
August 3, 2025
July 1, 2025
2.4 years
May 21, 2024
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Knowledge
A multiple-item knowledge test designed to test comprehension of the patient education document
Baseline and 30 minutes
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 Outcomes (3)
Satisfaction with the medical illustration
30 minutes
Reading Effort
30 minutes
Acceptability
30 minutes
Study Arms (20)
Medical Illustration Design Distinction 1, version A
EXPERIMENTALMedical Illustration Design Distinction 1, version A
Medical Illustration Design Distinction 1, version B
EXPERIMENTALMedical Illustration Design Distinction 1, version B
Medical Illustration Design Distinction 2, version A
EXPERIMENTALMedical Illustration Design Distinction 2, version A
Medical Illustration Design Distinction 2, version B
EXPERIMENTALMedical Illustration Design Distinction 2, version B
Medical Illustration Design Distinction 3, version A
EXPERIMENTALMedical Illustration Design Distinction 3, version A
Medical Illustration Design Distinction 3, version B
EXPERIMENTALMedical Illustration Design Distinction 3, version B
Medical Illustration Design Distinction 4, version A
EXPERIMENTALMedical Illustration Design Distinction 4, version A
Medical Illustration Design Distinction 4, version B
EXPERIMENTALMedical Illustration Design Distinction 4, version B
Medical Illustration Design Distinction 5, version A
EXPERIMENTALMedical Illustration Design Distinction 5, version A
Medical Illustration Design Distinction 5, version B
EXPERIMENTALMedical Illustration Design Distinction 5, version B
Medical Illustration Design Distinction 6, version A
EXPERIMENTALMedical Illustration Design Distinction 6, version A
Medical Illustration Design Distinction 6, version B
EXPERIMENTALMedical Illustration Design Distinction 6, version B
Medical Illustration Design Distinction 7, version A
EXPERIMENTALMedical Illustration Design Distinction 7, version A
Medical Illustration Design Distinction 7, version B
EXPERIMENTALMedical Illustration Design Distinction 7, version B
Medical Illustration Design Distinction 8, version A
EXPERIMENTALMedical Illustration Design Distinction 8, version A
Medical Illustration Design Distinction 8, version B
EXPERIMENTALMedical Illustration Design Distinction 8, version B
Medical Illustration Design Distinction 9, version A
EXPERIMENTALMedical Illustration Design Distinction 9, version A
Medical Illustration Design Distinction 9, version B
EXPERIMENTALMedical Illustration Design Distinction 9, version B
Medical Illustration Design Distinction 10, version A
EXPERIMENTALMedical Illustration Design Distinction 10, version A
Medical Illustration Design Distinction 10, version B
EXPERIMENTALMedical Illustration Design Distinction 10, version B
Interventions
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.
Eligibility Criteria
You may qualify if:
- Over 18 years old
- Speaks English or Spanish fluently
- Is able to independently consent
- Has adequate corrected vision to read patient education documents
You may not qualify if:
- \* None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northeastern Universitylead
- Tufts Medical Centercollaborator
- Boston Universitycollaborator
Study Sites (2)
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Northeastern University
Boston, Massachusetts, 02115, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Bickmore, PhD
Northeastern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2024
First Posted
May 30, 2024
Study Start
March 25, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
August 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Prior to end of the study.
- Access Criteria
- Sharing of de-identified human subjects data will be consistent with HIPAA guidelines and the Final NIH Statement on Sharing Research Data. We do not anticipate any limitations on sharing.
Transcripts from 100 cognitive interviews, and quantitative measures of comprehension and anxiety from 7,600 participant reactions to patient education documents will be generated. We will create de-identified data sets of all quantitative human subjects data that will be preserved and shared. The purpose for creating this is to allow other investigators access to the data to both validate our findings and to further advance inquiry in the field.