HealthyNCT06435819
ECA-enhanced Document Explanation RCT
A study testing Embodied Conversational Agent (ECA) in people with Healthy, run by Northeastern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Embodied Conversational Agent (ECA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Speaks English or Spanish fluently
- Is able to independently consent
- Has adequate corrected vision to read patient education documents
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Cameron Neeson, 617-636-5747, cameron.neeson@tuftsmedicalcenter.org
- Recruiting
Northeastern University
Boston, Massachusetts, 02115
Madison Blain, 617-858-6727, m.blain@northeastern.edu
Tim Bickmore, PhD, 617-373-5477, t.bickmore@northeastern.edu
About this study
Official title: Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 2: 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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Embodied Conversational Agent (ECA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embodied Conversational Agent (ECA)Other
A computer-animated character that can explain a medical illustration to laypersons.
| Study group | Role | What they receive |
|---|---|---|
| ECA-2D | Experimental | Participants read a patient education document with the assistance of an embodied conversational agent rendered in 2D on a computer monitor. Receives: Other: Embodied Conversational Agent (ECA) |
| ECA-3D | Experimental | Participants read a patient education document with the assistance of an embodied conversational agent in virtual reality. Receives: Other: Embodied Conversational Agent (ECA) |
| CONTROL | No intervention | Participants read a patient education document without assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
A multiple-item knowledge test designed to test comprehension of the patient education document
Measured: 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.
Measured: 30 minutes
Secondary outcomes (3)
Satisfaction with illustration
Likert items to assess satisfaction with the document and illustration
Measured: 30 minutes
Reading Effort
Likert items to assess perceived effort in reading a document and illustration
Measured: 30 minutes
Acceptability
Likert items to assess acceptability and appropriateness of the illustration
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start5 Sep 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-treatment between-subjects randomized experiment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center, Boston University
- Responsible party
- Sponsor
- Investigators
- Timothy Bickmore, PhD, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435819
- Sponsor's protocol ID
- 427441
- Status last verified
- Sep 2025
- First submitted
- 21 May 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 2: ECA-enhanced Document Explanation RCT
- ClinicalTrials.gov ID
- NCT06435819
- Acronym / sponsor ID
- 427441
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- Tufts Medical Center, Boston University
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 3-treatment between-subjects randomized experiment
| Arm | Type | Receives |
|---|---|---|
| ECA-2D | Experimental | Other: Embodied Conversational Agent (ECA)Participants read a patient education document with the assistance of an embodied conversational agent rendered in 2D on a computer monitor. |
| ECA-3D | Experimental | Other: Embodied Conversational Agent (ECA)Participants read a patient education document with the assistance of an embodied conversational agent in virtual reality. |
| CONTROL | No intervention | –Participants read a patient education document without assistance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Speaks English or Spanish fluently
- Is able to independently consent
- Has adequate corrected vision to read patient education documents
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embodied Conversational Agent (ECA)A computer-animated character that can explain a medical illustration to laypersons. | Other | ECA-2D, ECA-3D |
Primary outcome
Knowledge
Time frame: Baseline and 30 minutes
A multiple-item knowledge test designed to test comprehension of the patient education document
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.
3 secondary outcomes
Satisfaction with illustration
Time frame: 30 minutes
Reading Effort
Time frame: 30 minutes
Acceptability
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy Bickmore, PhD principal investigator
Northeastern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embodied Conversational Agent (ECA) in people with Healthy, run by Northeastern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Bickmore, PhD (6173735477, t.bickmore@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (time frame: Baseline and 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.