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NCT Number: NCT06435819

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.

Recruiting

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeastern University, Boston, Massachusetts, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Embodied conversational agent (ECA)

Other

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

Primary outcomes

  1. Knowledge

    Time frame: Baseline and 30 minutes

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

  2. 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.

Secondary outcomes

  1. Satisfaction with illustration

    Time frame: 30 minutes

    Likert items to assess satisfaction with the document and illustration

  2. Reading Effort

    Time frame: 30 minutes

    Likert items to assess perceived effort in reading a document and illustration

  3. Acceptability

    Time frame: 30 minutes

    Likert items to assess acceptability and appropriateness of the illustration

Study contacts

Contact information is provided by the study sponsor or research team.

Timothy Bickmore, PhD

CONTACT

[email protected]

6173735477

Sponsors and collaborators

Lead sponsor

Northeastern University

Other

Collaborators

  • Boston University
  • Tufts Medical Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 30, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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