NCT06435806

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,200

participants targeted

Target at P75+ for not_applicable healthy

Timeline
8mo left

Started Mar 2024

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Mar 2024Jan 2027

Study Start

First participant enrolled

March 25, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

2.4 years

First QC Date

May 21, 2024

Last Update Submit

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

EXPERIMENTAL

Medical Illustration Design Distinction 1, version A

Other: Medical Illustration design

Medical Illustration Design Distinction 1, version B

EXPERIMENTAL

Medical Illustration Design Distinction 1, version B

Other: Medical Illustration design

Medical Illustration Design Distinction 2, version A

EXPERIMENTAL

Medical Illustration Design Distinction 2, version A

Other: Medical Illustration design

Medical Illustration Design Distinction 2, version B

EXPERIMENTAL

Medical Illustration Design Distinction 2, version B

Other: Medical Illustration design

Medical Illustration Design Distinction 3, version A

EXPERIMENTAL

Medical Illustration Design Distinction 3, version A

Other: Medical Illustration design

Medical Illustration Design Distinction 3, version B

EXPERIMENTAL

Medical Illustration Design Distinction 3, version B

Other: Medical Illustration design

Medical Illustration Design Distinction 4, version A

EXPERIMENTAL

Medical Illustration Design Distinction 4, version A

Other: Medical Illustration design

Medical Illustration Design Distinction 4, version B

EXPERIMENTAL

Medical Illustration Design Distinction 4, version B

Other: Medical Illustration design

Medical Illustration Design Distinction 5, version A

EXPERIMENTAL

Medical Illustration Design Distinction 5, version A

Other: Medical Illustration design

Medical Illustration Design Distinction 5, version B

EXPERIMENTAL

Medical Illustration Design Distinction 5, version B

Other: Medical Illustration design

Medical Illustration Design Distinction 6, version A

EXPERIMENTAL

Medical Illustration Design Distinction 6, version A

Other: Medical Illustration design

Medical Illustration Design Distinction 6, version B

EXPERIMENTAL

Medical Illustration Design Distinction 6, version B

Other: Medical Illustration design

Medical Illustration Design Distinction 7, version A

EXPERIMENTAL

Medical Illustration Design Distinction 7, version A

Other: Medical Illustration design

Medical Illustration Design Distinction 7, version B

EXPERIMENTAL

Medical Illustration Design Distinction 7, version B

Other: Medical Illustration design

Medical Illustration Design Distinction 8, version A

EXPERIMENTAL

Medical Illustration Design Distinction 8, version A

Other: Medical Illustration design

Medical Illustration Design Distinction 8, version B

EXPERIMENTAL

Medical Illustration Design Distinction 8, version B

Other: Medical Illustration design

Medical Illustration Design Distinction 9, version A

EXPERIMENTAL

Medical Illustration Design Distinction 9, version A

Other: Medical Illustration design

Medical Illustration Design Distinction 9, version B

EXPERIMENTAL

Medical Illustration Design Distinction 9, version B

Other: Medical Illustration design

Medical Illustration Design Distinction 10, version A

EXPERIMENTAL

Medical Illustration Design Distinction 10, version A

Other: Medical Illustration design

Medical Illustration Design Distinction 10, version B

EXPERIMENTAL

Medical Illustration Design Distinction 10, version B

Other: Medical Illustration design

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.

Medical Illustration Design Distinction 1, version AMedical Illustration Design Distinction 1, version BMedical Illustration Design Distinction 10, version AMedical Illustration Design Distinction 10, version BMedical Illustration Design Distinction 2, version AMedical Illustration Design Distinction 2, version BMedical Illustration Design Distinction 3, version AMedical Illustration Design Distinction 3, version BMedical Illustration Design Distinction 4, version AMedical Illustration Design Distinction 4, version BMedical Illustration Design Distinction 5, version AMedical Illustration Design Distinction 5, version BMedical Illustration Design Distinction 6, version AMedical Illustration Design Distinction 6, version BMedical Illustration Design Distinction 7, version AMedical Illustration Design Distinction 7, version BMedical Illustration Design Distinction 8, version AMedical Illustration Design Distinction 8, version BMedical Illustration Design Distinction 9, version AMedical Illustration Design Distinction 9, version B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

NOT YET RECRUITING

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

  • Timothy Bickmore, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Bickmore, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: We will select 10 binary distinctions of medical illustration design elements and test each in a two-arm between-subjects evaluation.
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

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.

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.

Locations