ECA-enhanced Document Explanation RCT

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435819
• Other study ID #: 427441
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2026
• Est. completion date: September 1, 2027

Study information

• Verified date: May 2024
• Source: Northeastern University
• Contact: Timothy Bickmore, PhD
• Phone: 6173735477
• Email: t.bickmore[@]northeastern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old

• Speaks English or Spanish ?uently

• Is able to independently consent

• Has adequate corrected vision to read patient education documents

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Embodied Conversational Agent (ECA)
A computer-animated character that can explain a medical illustration to laypersons.

Locations

Country	Name	City	State
United States	Northeastern University	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Northeastern University	Boston University, Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge	A multiple-item knowledge test designed to test comprehension of the patient education document	Baseline and 30 minutes
Primary	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	Satisfaction with illustration	Likert items to assess satisfaction with the document and illustration	30 minutes
Secondary	Reading Effort	Likert items to assess perceived effort in reading a document and illustration	30 minutes
Secondary	Acceptability	Likert items to assess acceptability and appropriateness of the illustration	30 minutes