HealthyNCT06435806
Medical Illustration Design Characteristic Evaluation
A study testing Medical Illustration design in people with Healthy, run by Northeastern University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Medical Illustration design
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,200 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Mar 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Speaks English or Spanish fluently
- Is able to independently consent
- Has adequate corrected vision to read patient education documents
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Cameron Neeson, 6176365747, cameron.neeson@tuftsmedicalcenter.org
- Recruiting
Northeastern University
Boston, Massachusetts, 02115
Madison Blain, (617) - 858 - 6727, m.blain@northeastern.edu
About this study
Official title: Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 1: Medical Illustration Design Characteristic Evaluation
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.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- Medical Illustration design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Illustration designOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical Illustration Design Distinction 1, version A | Experimental | Medical Illustration Design Distinction 1, version A Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 1, version B | Experimental | Medical Illustration Design Distinction 1, version B Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 2, version A | Experimental | Medical Illustration Design Distinction 2, version A Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 2, version B | Experimental | Medical Illustration Design Distinction 2, version B Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 3, version A | Experimental | Medical Illustration Design Distinction 3, version A Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 3, version B | Experimental | Medical Illustration Design Distinction 3, version B Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 4, version A | Experimental | Medical Illustration Design Distinction 4, version A Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 4, version B | Experimental | Medical Illustration Design Distinction 4, version B Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 5, version A | Experimental | Medical Illustration Design Distinction 5, version A Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 5, version B | Experimental | Medical Illustration Design Distinction 5, version B Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 6, version A | Experimental | Medical Illustration Design Distinction 6, version A Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 6, version B | Experimental | Medical Illustration Design Distinction 6, version B Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 7, version A | Experimental | Medical Illustration Design Distinction 7, version A Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 7, version B | Experimental | Medical Illustration Design Distinction 7, version B Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 8, version A | Experimental | Medical Illustration Design Distinction 8, version A Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 8, version B | Experimental | Medical Illustration Design Distinction 8, version B Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 9, version A | Experimental | Medical Illustration Design Distinction 9, version A Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 9, version B | Experimental | Medical Illustration Design Distinction 9, version B Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 10, version A | Experimental | Medical Illustration Design Distinction 10, version A Receives: Other: Medical Illustration design |
| Medical Illustration Design Distinction 10, version B | Experimental | Medical Illustration Design Distinction 10, version B Receives: Other: Medical Illustration design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
A multiple-item knowledge test designed to test comprehension of the patient education document
Measured: 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.
Measured: 30 minutes
Secondary outcomes (3)
Satisfaction with the medical illustration
Likert items to assess satisfaction with the document and illustration
Measured: 30 minutes
Reading Effort
Likert items to assess perceived effort in reading a document and illustration
Measured: 30 minutes
Acceptability
Likert items to assess acceptability and appropriateness of the illustration
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start25 Mar 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- We will select 10 binary distinctions of medical illustration design elements and test each in a two-arm between-subjects evaluation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center, Boston University
- Responsible party
- Sponsor
- Investigators
- Timothy Bickmore, PhD, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435806
- Sponsor's protocol ID
- 427440
- Status last verified
- Jul 2025
- First submitted
- 21 May 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 1: Medical Illustration Design Characteristic Evaluation
- ClinicalTrials.gov ID
- NCT06435806
- Acronym / sponsor ID
- 427440
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,200 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- Tufts Medical Center, Boston University
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 20
- Model description
- We will select 10 binary distinctions of medical illustration design elements and test each in a two-arm between-subjects evaluation.
| Arm | Type | Receives |
|---|---|---|
| Medical Illustration Design Distinction 1, version A | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 1, version A |
| Medical Illustration Design Distinction 1, version B | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 1, version B |
| Medical Illustration Design Distinction 2, version A | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 2, version A |
| Medical Illustration Design Distinction 2, version B | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 2, version B |
| Medical Illustration Design Distinction 3, version A | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 3, version A |
| Medical Illustration Design Distinction 3, version B | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 3, version B |
| Medical Illustration Design Distinction 4, version A | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 4, version A |
| Medical Illustration Design Distinction 4, version B | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 4, version B |
| Medical Illustration Design Distinction 5, version A | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 5, version A |
| Medical Illustration Design Distinction 5, version B | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 5, version B |
| Medical Illustration Design Distinction 6, version A | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 6, version A |
| Medical Illustration Design Distinction 6, version B | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 6, version B |
| Medical Illustration Design Distinction 7, version A | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 7, version A |
| Medical Illustration Design Distinction 7, version B | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 7, version B |
| Medical Illustration Design Distinction 8, version A | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 8, version A |
| Medical Illustration Design Distinction 8, version B | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 8, version B |
| Medical Illustration Design Distinction 9, version A | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 9, version A |
| Medical Illustration Design Distinction 9, version B | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 9, version B |
| Medical Illustration Design Distinction 10, version A | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 10, version A |
| Medical Illustration Design Distinction 10, version B | Experimental | Other: Medical Illustration designMedical Illustration Design Distinction 10, version B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Speaks English or Spanish fluently
- Is able to independently consent
- Has adequate corrected vision to read patient education documents
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Illustration designWe 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. | Other | Medical Illustration Design Distinction 1, version A, Medical Illustration Design Distinction 1, version B, Medical Illustration Design Distinction 10, version A, Medical Illustration Design Distinction 10, version B, Medical Illustration Design Distinction 2, version A, Medical Illustration Design Distinction 2, version B, Medical Illustration Design Distinction 3, version A, Medical Illustration Design Distinction 3, version B, Medical Illustration Design Distinction 4, version A, Medical Illustration Design Distinction 4, version B, Medical Illustration Design Distinction 5, version A, Medical Illustration Design Distinction 5, version B, Medical Illustration Design Distinction 6, version A, Medical Illustration Design Distinction 6, version B, Medical Illustration Design Distinction 7, version A, Medical Illustration Design Distinction 7, version B, Medical Illustration Design Distinction 8, version A, Medical Illustration Design Distinction 8, version B, Medical Illustration Design Distinction 9, version A, Medical Illustration Design Distinction 9, version B |
Primary outcome
Knowledge
Time frame: Baseline and 30 minutes
A multiple-item knowledge test designed to test comprehension of the patient education document
State Anxiety scale from State-Trait Anxiety Inventory
Time frame: 30 minutes
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.
3 secondary outcomes
Satisfaction with the medical illustration
Time frame: 30 minutes
Reading Effort
Time frame: 30 minutes
Acceptability
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy Bickmore, PhD principal investigator
Northeastern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Illustration design in people with Healthy, run by Northeastern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Bickmore, PhD (6173735477, t.bickmore@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (time frame: Baseline and 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.