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Clinical Trials/NCT06435819
NCT06435819
Recruiting
Not Applicable

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

Northeastern University2 sites in 1 country300 target enrollmentSeptember 5, 2025
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Northeastern University
Enrollment
300
Locations
2
Primary Endpoint
State Anxiety scale from State-Trait Anxiety Inventory
Status
Recruiting
Last Updated
7 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 5, 2025
End Date
September 1, 2027
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

State Anxiety scale from State-Trait Anxiety Inventory

Time Frame: 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

Time Frame: Baseline and 30 minutes

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

Secondary Outcomes

  • Acceptability(30 minutes)
  • Reading Effort(30 minutes)
  • Satisfaction with illustration(30 minutes)

Study Sites (2)

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