## Protocol Section
### Identification Module
**NCT ID:** NCT06435806

**Brief Title:** Medical Illustration Design Characteristic Evaluation

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

#### Organization Study ID Info
**ID:** 427440
#### Organization
**Class:** OTHER
**Full Name:** Northeastern University
### Status Module
#### Completion Date
**Date:** 2027-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-25

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Tufts Medical Center

**Class:** OTHER

**Name:** Boston University

#### Lead Sponsor

**Class:** OTHER

**Name:** Northeastern University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** We will select 10 binary distinctions of medical illustration design elements and test each in a two-arm between-subjects evaluation.

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 8200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Medical Illustration Design Distinction 1, version A

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 1, version A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Medical Illustration Design Distinction 1, version B

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 1, version B

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Medical Illustration Design Distinction 2, version A

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 2, version A

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Medical Illustration Design Distinction 2, version B

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 2, version B

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Medical Illustration Design Distinction 3, version A

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 3, version A

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** Medical Illustration Design Distinction 3, version B

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 3, version B

**Type:** EXPERIMENTAL

#### Arm Group 7

**Description:** Medical Illustration Design Distinction 4, version A

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 4, version A

**Type:** EXPERIMENTAL

#### Arm Group 8

**Description:** Medical Illustration Design Distinction 4, version B

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 4, version B

**Type:** EXPERIMENTAL

#### Arm Group 9

**Description:** Medical Illustration Design Distinction 5, version A

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 5, version A

**Type:** EXPERIMENTAL

#### Arm Group 10

**Description:** Medical Illustration Design Distinction 5, version B

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 5, version B

**Type:** EXPERIMENTAL

#### Arm Group 11

**Description:** Medical Illustration Design Distinction 6, version A

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 6, version A

**Type:** EXPERIMENTAL

#### Arm Group 12

**Description:** Medical Illustration Design Distinction 6, version B

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 6, version B

**Type:** EXPERIMENTAL

#### Arm Group 13

**Description:** Medical Illustration Design Distinction 7, version A

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 7, version A

**Type:** EXPERIMENTAL

#### Arm Group 14

**Description:** Medical Illustration Design Distinction 7, version B

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 7, version B

**Type:** EXPERIMENTAL

#### Arm Group 15

**Description:** Medical Illustration Design Distinction 8, version A

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 8, version A

**Type:** EXPERIMENTAL

#### Arm Group 16

**Description:** Medical Illustration Design Distinction 8, version B

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 8, version B

**Type:** EXPERIMENTAL

#### Arm Group 17

**Description:** Medical Illustration Design Distinction 9, version A

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 9, version A

**Type:** EXPERIMENTAL

#### Arm Group 18

**Description:** Medical Illustration Design Distinction 9, version B

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 9, version B

**Type:** EXPERIMENTAL

#### Arm Group 19

**Description:** Medical Illustration Design Distinction 10, version A

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 10, version A

**Type:** EXPERIMENTAL

#### Arm Group 20

**Description:** Medical Illustration Design Distinction 10, version B

**Intervention Names:**

- Other: Medical Illustration design

**Label:** Medical Illustration Design Distinction 10, version B

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 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

**Description:** 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.

**Name:** Medical Illustration design

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** A multiple-item knowledge test designed to test comprehension of the patient education document

**Measure:** Knowledge

**Time Frame:** Baseline and 30 minutes

**Description:** 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.

**Measure:** State Anxiety scale from State-Trait Anxiety Inventory

**Time Frame:** 30 minutes

#### Secondary Outcomes

**Description:** Likert items to assess satisfaction with the document and illustration

**Measure:** Satisfaction with the medical illustration

**Time Frame:** 30 minutes

**Description:** Likert items to assess perceived effort in reading a document and illustration

**Measure:** Reading Effort

**Time Frame:** 30 minutes

**Description:** Likert items to assess acceptability and appropriateness of the illustration

**Measure:** Acceptability

**Time Frame:** 30 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

\* None

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** t.bickmore@northeastern.edu

**Name:** Timothy Bickmore, PhD

**Phone:** 6173735477

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Boston

**Contacts:**

***Contact 1:***

- **Email:** cameron.neeson@tuftsmedicalcenter.org

- **Name:** Cameron Neeson

- **Phone:** 617-636-5747

- **Role:** CONTACT

**Country:** United States

**Facility:** Tufts Medical Center

**State:** Massachusetts

**Status:** NOT_YET_RECRUITING

**Zip:** 02111

**Location 2:**

**City:** Boston

**Contacts:**

***Contact 1:***

- **Email:** m.blain@northeastern.edu

- **Name:** Madison Blain

- **Phone:** 617-858-6727

- **Role:** CONTACT

**Country:** United States

**Facility:** Northeastern University

**State:** Massachusetts

**Status:** RECRUITING

**Zip:** 02115

#### Overall Officials

**Official 1:**

**Affiliation:** Northeastern University

**Name:** Timothy Bickmore, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**Description:** 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.

**Info Types:**

- STUDY_PROTOCOL

- ICF

**IPD Sharing:** YES

**Time Frame:** Prior to end of the study.

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
