ECA-enhanced Document Explanation RCT

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Embodied Conversational Agent (ECA)

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).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timothy Bickmore, PhD; Phone Number: 6173735477; Email: t.bickmore@northeastern.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Not yet recruiting
      • Tufts Medical Center
      • Contact: Cameron Neeson; Phone Number: 617-636-5747; Email: cameron.neeson@tuftsmedicalcenter.org
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Northeastern University
      • Contact: Madison Blain; Phone Number: 617-858-6727; Email: m.blain@northeastern.edu
      • Contact: Tim Bickmore, PhD; Phone Number: 617-373-5477; Email: t.bickmore@northeastern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECA-2D; Participants read a patient education document with the assistance of an embodied conversational agent rendered in 2D on a computer monitor.	Other: Embodied Conversational Agent (ECA); A computer-animated character that can explain a medical illustration to laypersons.
Experimental: ECA-3D; Participants read a patient education document with the assistance of an embodied conversational agent in virtual reality.	Other: Embodied Conversational Agent (ECA); A computer-animated character that can explain a medical illustration to laypersons.
No Intervention: CONTROL; Participants read a patient education document without assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with illustration	Likert items to assess satisfaction with the document and illustration	30 minutes
Reading Effort	Likert items to assess perceived effort in reading a document and illustration	30 minutes
Acceptability	Likert items to assess acceptability and appropriateness of the illustration	30 minutes

Collaborators and Investigators

• Sponsor: Northeastern University
• Collaborators: Boston University; Tufts Medical Center
• Investigators: Principal Investigator: Timothy Bickmore, PhD, Northeastern University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 427441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.
• IPD Sharing Time Frame: Prior to end of the study.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No