ECA-enhanced Document Explanation RCT
Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 2: ECA-enhanced Document Explanation RCT
1 other identifier
interventional
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Sep 2025
Typical duration for not_applicable healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedStudy Start
First participant enrolled
September 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
October 3, 2025
September 1, 2025
1.9 years
May 21, 2024
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Knowledge
A multiple-item knowledge test designed to test comprehension of the patient education document
Baseline and 30 minutes
State Anxiety scale from State-Trait Anxiety Inventory
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.
30 minutes
Secondary Outcomes (3)
Satisfaction with illustration
30 minutes
Reading Effort
30 minutes
Acceptability
30 minutes
Study Arms (3)
ECA-2D
EXPERIMENTALParticipants read a patient education document with the assistance of an embodied conversational agent rendered in 2D on a computer monitor.
ECA-3D
EXPERIMENTALParticipants read a patient education document with the assistance of an embodied conversational agent in virtual reality.
CONTROL
NO INTERVENTIONParticipants read a patient education document without assistance.
Interventions
A computer-animated character that can explain a medical illustration to laypersons.
Eligibility Criteria
You may qualify if:
- Over 18 years old
- Speaks English or Spanish fluently
- Is able to independently consent
- Has adequate corrected vision to read patient education documents
You may not qualify if:
- \* None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northeastern Universitylead
- Tufts Medical Centercollaborator
- Boston Universitycollaborator
Study Sites (2)
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Northeastern University
Boston, Massachusetts, 02115, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Bickmore, PhD
Northeastern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2024
First Posted
May 30, 2024
Study Start
September 5, 2025
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
October 3, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Prior to end of the study.
- Access Criteria
- Sharing of de-identified human subjects data will be consistent with HIPAA guidelines and the Final NIH Statement on Sharing Research Data. We do not anticipate any limitations on sharing.
Quantitative measures of comprehension and anxiety will be collected from participants who either have patient education documents explained to them by embodied conversational agents or read the documents themselves. We will create de-identified data sets of all quantitative human subjects data that will be preserved and shared. The purpose for creating this is to allow other investigators access to the data to both validate our findings and to further advance inquiry in the field.