Adaptive Real-Time Voice Virtual Patients for Clinical Communication Training (RSTM-VP)

May 28, 2026 updated by: Wang Shalong

Effects of Emotionally and Interactionally Adaptive Real-Time Voice Virtual Patients on Clinical Communication Training in Resident Physicians: A Three-Arm Randomized Controlled Trial

This study evaluated whether an emotionally and interactionally adaptive real-time voice virtual patient can improve clinical communication training for resident physicians. Communication with patients in emotionally challenging situations, such as breaking bad news, requires clinicians to deliver information clearly, recognize emotional cues, respond empathically, and maintain a coherent interaction. Standardized patient training can support these skills but is resource intensive and difficult to provide repeatedly. Real-time voice virtual patients may offer scalable practice opportunities, but simple spoken interaction alone may not provide patient responses that change meaningfully according to the learner's communication.

The adaptive virtual patient used in this study was designed to update the patient's emotional tone, openness, defensiveness, and interactional style during the conversation based on the learner's communication behavior. The study compared this adaptive virtual patient training with a non-adaptive real-time voice virtual patient and with standardized patient training.

Resident physicians were randomly assigned in a 1:1:1 ratio to one of three groups: emotionally and interactionally adaptive virtual patient training, non-adaptive virtual patient training, or standardized patient training. Participants completed two communication training sessions focused on breaking bad news. After training, participants completed learner-reported measures of perceived response contingency and patient realism. Approximately four weeks later, participants completed a mini-objective structured clinical examination using a human standardized patient to assess communication performance in a delayed near-transfer setting.

The primary outcome was the total mini-OSCE communication score at four weeks. Secondary outcomes included mini-OSCE domain scores for structured delivery, emotional responsiveness, and interactional process; learner-reported response contingency and patient realism; and expert-rated behavioral consistency and clinical credibility of virtual patient interactions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
195

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Resident physicians in postgraduate years 1-3.
  • Participants who had received basic clinical communication training or related instruction.
  • Participants who had not received systematic, specialized training in breaking bad news communication.
  • Able to complete two training sessions and the four-week follow-up mini-OSCE assessment.
  • Willing to participate and able to provide written informed consent.

Exclusion Criteria:

  • Prior systematic training in breaking bad news, advanced communication skills, or similar specialized communication training.
  • Prior participation in pilot testing or system testing related to this study.
  • Unable to complete the required training sessions or follow-up assessment.
  • Unwilling to have training or assessment sessions recorded for research scoring and analysis.
  • Concurrent participation in another communication-skills intervention study that could affect communication performance.
  • Any other condition judged by the investigators to make participation inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adaptive Virtual Patient Training
Participants assigned to this arm completed two breaking-bad-news communication training sessions with an emotionally and interactionally adaptive real-time voice virtual patient. The virtual patient updated its emotional tone, openness, defensiveness, and interactional style during the conversation based on the participant's communication behavior.
Behavioral: Adaptive Real-Time Voice Virtual Patient Training
Participants completed two breaking-bad-news communication training sessions with an emotionally and interactionally adaptive real-time voice virtual patient. The virtual patient interacted with participants through continuous spoken dialogue and dynamically updated its emotional tone, openness, defensiveness, and interactional style based on the participant's communication behavior. The adaptive mechanism was designed to provide behavior-contingent patient responses during the encounter.
Active Comparator: Non-Adaptive Virtual Patient Training
Participants assigned to this arm completed two breaking-bad-news communication training sessions with a non-adaptive real-time voice virtual patient. The platform, case structure, voice interaction format, and training exposure were matched to the adaptive virtual patient arm, but the patient's emotional and interactional style did not dynamically update based on participant communication behavior.
Behavioral: Non-Adaptive Real-Time Voice Virtual Patient Training
Participants completed two breaking-bad-news communication training sessions with a non-adaptive real-time voice virtual patient. The platform, case structure, spoken interaction format, training exposure, and communication tasks were matched to the adaptive virtual patient condition. Unlike the adaptive condition, the virtual patient did not dynamically update its emotional or interactional state based on the participant's communication behavior.
Active Comparator: Standardized Patient Training
Participants assigned to this arm completed two breaking-bad-news communication training sessions with trained standardized patients. Cases, training objectives, session duration, and communication tasks were structurally matched to the virtual patient arms.
Behavioral: Standardized Patient Training
Participants completed two breaking-bad-news communication training sessions with trained human standardized patients. The cases, training objectives, session duration, and communication tasks were structurally matched to the virtual patient training conditions. Standardized patients were trained to portray the assigned clinical communication scenarios using standardized case scripts and interactional guidance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Four-Week Mini-OSCE Total Communication Score
Time Frame: 4 weeks after completion of training
Communication performance was assessed approximately four weeks after training using a mini-objective structured clinical examination with a human standardized patient. The total score was based on a 9-item structured communication rating scale covering structured delivery, emotional responsiveness, and interactional process. Each item was rated from 1 to 5, yielding a total score range of 9 to 45. Higher scores indicate better clinical communication performance. Scores from two blinded expert raters were averaged to generate participant-level total scores.
4 weeks after completion of training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Four-Week Mini-OSCE Domain Scores
Time Frame: 4 weeks after completion of training
Domain scores from the four-week mini-OSCE were calculated for three communication domains: structured delivery, emotional responsiveness, and interactional process. Each domain included three items rated from 1 to 5, yielding a domain score range of 3 to 15. Higher scores indicate better performance in the corresponding communication domain.
4 weeks after completion of training
Learner-Reported Perceived Response Contingency and Patient Realism
Time Frame: Immediately after training session 2 (each session was 45 minutes)
Learner-reported interaction measures were assessed after training using 7-point Likert-scale items. Perceived response contingency was calculated as the mean of two items evaluating whether the patient's emotional or interpersonal responses changed during the conversation and whether these changes appeared to depend on how the participant communicated. Perceived patient realism was assessed using a single item evaluating whether the patient's emotional and interpersonal responses felt realistic for a real patient in a clinical conversation. Higher scores indicate stronger perceived response contingency and greater perceived patient realism.
Immediately after training session 2 (each session was 45 minutes)
Expert-Rated Behavioral Consistency and Clinical Credibility of Virtual Patient Interactions
Time Frame: Training session 2(each session was 45 minutes)
Virtual patient interactions recorded during training session 2 were later assessed by blinded expert raters using 7-point Likert-scale items. Behavioral consistency evaluated whether the virtual patient's emotional tone, interpersonal stance, and overall behavior remained coherent with the case background and internally consistent throughout the interaction. Clinical credibility evaluated whether the virtual patient's emotional and interactional responses were clinically believable for a real patient in the corresponding situation. Higher scores indicate greater behavioral consistency and clinical credibility. This outcome was assessed only for the two virtual patient groups.
Training session 2(each session was 45 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wang Shalong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XY-Z0379-01
  • 2026JJ50060 (Other Grant/Funding Number: Hunan Provincial Natural Science Foundation of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared because participant consent and institutional ethics approval do not permit unrestricted public release of human-subject data. Summary data and study materials sufficient to interpret the findings will be provided in the publication and supplementary materials. Additional deidentified data may be made available from the corresponding author upon reasonable request, subject to institutional and ethics approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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