ECA-enhanced Document Explanation RCT

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Other: Embodied Conversational Agent (ECA)

• Registration Number: NCT06435819
• Lead Sponsor: Northeastern University

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).

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-24
• Last Update Submitted: 2024-05-24
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Study Start: 2026-09-01
• Primary Completion: 2027-08-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECA-2D	Embodied Conversational Agent (ECA)	Participants read a patient education document with the assistance of an embodied conversational agent rendered in 2D on a computer monitor.
ECA-3D	Embodied Conversational Agent (ECA)	Participants read a patient education document with the assistance of an embodied conversational agent in virtual reality.

Primary Outcome Measures

Name	Time	Method
State Anxiety scale from State-Trait Anxiety Inventory	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.
Knowledge	Baseline and 30 minutes	A multiple-item knowledge test designed to test comprehension of the patient education document

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Northeastern University; 🇺🇸 Boston, Massachusetts, United States