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ECA-enhanced Document Explanation RCT

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06435819
Enrollment
300
Registered
2024-05-30
Start date
2025-09-05
Completion date
2027-09-01
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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).

Interventions

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

Sponsors

Tufts Medical Center
CollaboratorOTHER
Boston University
CollaboratorOTHER
Northeastern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

3-treatment between-subjects randomized experiment

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
KnowledgeBaseline and 30 minutesA multiple-item knowledge test designed to test comprehension of the patient education document
State Anxiety scale from State-Trait Anxiety Inventory30 minutesSelf-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

MeasureTime frameDescription
Satisfaction with illustration30 minutesLikert items to assess satisfaction with the document and illustration
Reading Effort30 minutesLikert items to assess perceived effort in reading a document and illustration
Acceptability30 minutesLikert items to assess acceptability and appropriateness of the illustration

Countries

United States

Contacts

Primary ContactTimothy Bickmore, PhD
t.bickmore@northeastern.edu6173735477

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026