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Recruiting NCT06435819

ECA-enhanced Document Explanation RCT

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Embodied Conversational Agent (ECA).
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Embodied Conversational Agent (ECA)
    A computer-animated character that can explain a medical illustration to laypersons.

Primary outcome measures

  • Knowledge [Time frame: Baseline and 30 minutes]
  • State Anxiety scale from State-Trait Anxiety Inventory [Time frame: 30 minutes]
Secondary outcome measures (3)
  • Satisfaction with illustration [Time frame: 30 minutes]
  • Reading Effort [Time frame: 30 minutes]
  • Acceptability [Time frame: 30 minutes]

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

\* None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 2 centers
  • Tufts Medical Center — Boston
  • Northeastern University — Boston

Identifiers

NCT: NCT06435819 · 427441

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗