Effectiveness of a Combined e-Learning and Virtual Reality Training Program for Healthcare Providers in Rheumatology

September 18, 2026 updated by: hvanmiddendorp, Leiden University

Context Matters: Training Healthcare Professionals in Communication to Maximize Placebo Effects and Minimize Nocebo Effects in Rheumatology: A Multicentre, Randomized Controlled Trial.

The goal of this clinical trial is to evaluate the effectiveness of communication training on the communication skills of the healthcare provider in the rheumatology department during consults with patients.

The main questions it aims to answer are:

  • Is communication training effective in increasing the self-perceived communication skills of the healthcare provider?
  • Is communication training effective in increasing the evaluation of patients on the communication skills of their corresponding healthcare provider?

Researchers will compare one group who will receive communication training to one group who will not receive any training to see if there is a significant difference in self-evaluation and patient-evaluation on their communication skills.

Participants will begin by completing a pre-test self-evaluation questionnaire, followed by communication training. After the training, they will complete a post-test self-evaluation questionnaire. Over the next eight weeks following the training, participants will gather evaluations from their patients on their communication skills during the most recent consultation.

Study Overview

Status

Status

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

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.

Detailed Description

Background: Leading experts on placebo and nocebo effects agree that healthcare providers should be trained to effectively leverage expectancy effects in clinical practice. However, these practices have rarely been implemented with many healthcare providers lacking the expertise to fully take care of patient expectancies. Thus, we developed an e-Learning course and a virtual training tool that trains healthcare professionals across all disciplines to communicate with patients in a manner that maximizes placebo effects and minimizes nocebo effects.

Aim: The current study aims to evaluate the effectiveness of the combined e-Learning course and Virtual Reality training at improving expectancy-based communication within the department of rheumatology.

Method: Dutch healthcare providers (n= 52) working across rheumatology departments in the Netherlands will be stratified on specialization (e.g., rheumatologist, physician assistant, nurse specialist, medical resident or medical researcher) and randomized to either the intervention (e-Learning + VR training) or the control group (no training + e-Learning knowledge exam). The effect of the training is evaluated by a pre-post self-evaluation of clinicians (main outcome: SE12) and patient evaluations (N= 884) (secondary outcome: QQPPI).

Participants: Healthcare providers participating in the study must be active and working in the rheumatology department. Additionally, they must see patients on a regular basis.

Patients must be 18 years or older and require a mastery of spoken and written Dutch.

Intervention tools: for the communication training consists of an e-Learning course with 6 modules, including: 1) Optimizing patient-provider relationship, 2) discussing expectations, 3) discussing the treatment rationale, 4) discussing risks and side-effects, 5) explain placebo and nocebo effects and 6) expectancy-based communication during tapering. The course also includes seven case-by-case study questions and a knowledge exam consisting of 15 randomized questions at the end of the course. Participants are required to pass the test with a minimal grade of 7.

The Virtual Reality app consists of 2 modules with each a separate virtual avatar representing a patient. The app incorporates A.I. generated dialogue that is bound to the topic of the case. The training is supported by a feedback system at the end of a playthrough and is designed for multiple playthroughs in order to create a 'learning by experience' effect.

Main outcomes: The primary outcome will be determined by comparing the scores of the two study groups on the validated self-evaluation questionnaire 'SE-12' before and after the intervention.

The secondary outcome will be determined by comparing the scores of the two groups on the validated patient-evaluation questionnaire 'QQPPI'.

Exploratory outcomes: Additional outcome measures will include comparing the average scores of the intervention and control groups on the e-Learning knowledge exam, as well as tracking the score progression of healthcare providers across multiple sessions of the Virtual Reality app.

After the conclusion of the study, the control group will be offered the same training as the intervention group.

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 (Estimated)

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.
936

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria for healthcare providers:

  • being 18 years or older
  • having a good command of the Dutch language, both written and spoken.
  • being a healthcare provider within the rheumatology department (e.g., rheumatologist, physician assistant, rheumatology nurse, medical resident, or medical researcher).
  • regularly seeing rheumatology patients during consultations.

No exclusion criteria, except for not having regular supervisory meetings with patients with rheumatic diseases.

Inclusion criteria for patients :

  • being 18 years or older
  • having a good command of the Dutch language, both written and spoken
  • having had a consultation with one of the participating healthcare providers (intervention or control group) within the past 8 weeks

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: Supportive Care
  • 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: Communicating training group

Healthcare providers in the experimental group receive communication training consisting of an e-Learning communication course and knowledge exam of 1 hour and communication training in a virtual reality environment with a virtual avatar for 1 hour.
Behavioral: Expectancy-based communication training for healthcare providers

An e-learning course comprising six modules, each featuring case-based questions, followed by a comprehensive knowledge exam. The course concludes with a Virtual Reality training program, which includes two immersive modules and AI-generated dialogue for an interactive learning experience.
No Intervention: No training group

Healthcare providers in the control group receive no training but have the opportunity to receive the training after the study has been concluded.

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
Changes in total scores from a pre-test to a post-test evaluation between the arms on the SE-12 self-evaluation questionnaire, supplemented with customized questions regarding patient expectations.
Time Frame: After inclusion into the study, which precedes the training with mostly a few weeks, a baseline assessment is done. After completing the training, a post-test evaluation is done, within approximately 2 weeks after the training.

The self-evaluation questionnaire consists of questions about communication skills, primarily focused on how certain the healthcare provider is in successfully performing a specific action during the consultation with a patient.

The ratings are scored on a scale of one to ten, with one being very unlikely and ten being very likely.
After inclusion into the study, which precedes the training with mostly a few weeks, a baseline assessment is done. After completing the training, a post-test evaluation is done, within approximately 2 weeks after the 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
Score difference between arms on patient-evaluation based on the QQPPI questionnaire, supplemented with customized questions regarding expectations for the communication skills of healthcare providers during their most recent consultation.
Time Frame: Patient-evaluations will be collected over the course of eight weeks after completing the communication training by healthcare providers

The patient-evaluation questionnaire consists of questions about statements and assertions concerning the most recent consultation.

The scale consists of five ratings, with 1 being 'I do not agree' and five being 'I fully agree'.
Patient-evaluations will be collected over the course of eight weeks after completing the communication training by healthcare providers

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.
Leiden University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Erasmus Medical Center
Leiden University Medical Center
VieCuri Medical Centre
Reade Rheumatology Research Institute
Medisch Spectrum Twente
Dijklander Hospital, Hoorn and Purmerend, The Netherlands
Frisius Medisch Centrum

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Henriët van Middendorp, PhD, Leiden University

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.
March 27, 2025

Primary Completion (Estimated)

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.
April 1, 2027

Study Completion (Estimated)

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.
July 1, 2027

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).
July 27, 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.
September 18, 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.
September 22, 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.
September 22, 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.
September 18, 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.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2024-06-10-A.W.M.Evers-V1-5522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Shared IPD will consist of pseudonymized demographic data, questionnaire results and performance on training measurements.

IPD Sharing Time Frame

Data will become available after publication of the study and remain available for 10 years.

IPD Sharing Access Criteria

The data will be securely restricted and access will be granted upon request to the author for research purposes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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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