## Protocol Section
### Identification Module
**NCT ID:** NCT06435819

**Brief Title:** ECA-enhanced Document Explanation RCT

**Official Title:** Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 2: ECA-enhanced Document Explanation RCT

#### Organization Study ID Info
**ID:** 427441
#### Organization
**Class:** OTHER
**Full Name:** Northeastern University
### Status Module
#### Completion Date
**Date:** 2027-09-01

**Type:** ESTIMATED

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

**Type:** ACTUAL

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

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2026-09-01

**Type:** ESTIMATED

**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 investigators will evaluate a computer-animated character that explains medical illustrations to people, comparing the character to having people understand the illustrations on their own, and also comparing the computer character on a computer display to one in immersive virtual reality. The investigators will determine which method leads to the best understanding and lowest anxiety.

**Detailed Description:** The investigators are developing a new approach to explaining patient education documents and illustrations to patients with varying levels of health literacy, involving the use of Embodied Conversational Agents (ECAs). The investigators will evaluate our ECA-augmented Document Explanation tool to determine whether it improves patient learning relative to traditional static patient education documents. The investigators will conduct a 3-arm randomized between-subjects experiment, in which participants read a patient education document with embedded medical illustration, either unaided (CONTROL), with the assistance of an ECA rendered in 2D on a standard computer monitor (ECA-2D), or with the assistance of an ECA in immersive Virtual Reality (ECA-3D).

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 3-treatment between-subjects randomized experiment

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants read a patient education document with the assistance of an embodied conversational agent rendered in 2D on a computer monitor.

**Intervention Names:**

- Other: Embodied Conversational Agent (ECA)

**Label:** ECA-2D

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants read a patient education document with the assistance of an embodied conversational agent in virtual reality.

**Intervention Names:**

- Other: Embodied Conversational Agent (ECA)

**Label:** ECA-3D

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants read a patient education document without assistance.

**Label:** CONTROL

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ECA-2D

- ECA-3D

**Description:** A computer-animated character that can explain a medical illustration to laypersons.

**Name:** Embodied Conversational Agent (ECA)

**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 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

**Country:** United States

**Facility:** Tufts Medical Center

**State:** Massachusetts

**Zip:** 02111

**Location 2:**

**City:** Boston

**Country:** United States

**Facility:** Northeastern University

**State:** Massachusetts

**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:** Quantitative measures of comprehension and anxiety will be collected from participants who either have patient education documents explained to them by embodied conversational agents or read the documents themselves. 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
