Rheumatic DiseasesNCT07835256
Effectiveness of a Combined e-Learning and Virtual Reality Training Program for Healthcare Providers in Rheumatology
A study testing Expectancy-based communication training for healthcare providers in people with Rheumatic Diseases, run by Leiden University at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Expectancy-based communication training for healthcare providers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 936 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Mar 2025to Jul 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
- 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.
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University
Leiden, South Holland, 2333AK
Victor Leong, MSc, 0646167311, o.v.leong@fsw.leidenuniv.nl
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Rheumatic Diseases
- Being tested
- Expectancy-based communication training for healthcare providers
- Keywords
- rheumatology, communication, placebo effects
- Medical subject headings
- Rheumatic Diseases, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectancy-based communication training for healthcare providersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Communicating training group | Experimental | 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. Receives: Behavioral: Expectancy-based communication training for healthcare providers |
| No training group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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 outcomes (1)
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.
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'.
Measured: Patient-evaluations will be collected over the course of eight weeks after completing the communication training by healthcare providers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start27 Mar 2025
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants consist of 52 healthcare providers and 884 patients. For healthcare providers, one group will receive communication training (experimental group) and the other will receive no training (control group). The control group will receive the training at study end. The patient population will include individuals who have had a consultation with a healthcare provider from either the experimental group or the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 936 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Reade Rheumatology Research Institute, Erasmus Medical Center, VieCuri Medical Centre, Medisch Spectrum Twente, Frisius Medisch Centrum, Dijklander Hospital, Hoorn and Purmerend, The Netherlands
- Responsible party
- Principal investigator, hvanmiddendorp, Leiden University
- Investigators
- Henriët van Middendorp, PhD, Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835256
- Sponsor's protocol ID
- 2024-06-10-A.W.M.Evers-V1-5522
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared IPD will consist of pseudonymized demographic data, questionnaire results and performance on training measurements.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Context Matters: Training Healthcare Professionals in Communication to Maximize Placebo Effects and Minimize Nocebo Effects in Rheumatology: A Multicentre, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07835256
- Acronym / sponsor ID
- 2024-06-10-A.W.M.Evers-V1-5522
- Conditions
- Rheumatic Diseases
- Keywords
- rheumatology, communication, placebo effects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 936 participants (estimated)
- Lead sponsor
- Leiden UniversityUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Reade Rheumatology Research Institute, Erasmus Medical Center, VieCuri Medical Centre, Medisch Spectrum Twente, Frisius Medisch Centrum, Dijklander Hospital, Hoorn and Purmerend, The Netherlands
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 Sep 2026 (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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants consist of 52 healthcare providers and 884 patients. For healthcare providers, one group will receive communication training (experimental group) and the other will receive no training (control group). The control group will receive the training at study end. The patient population will include individuals who have had a consultation with a healthcare provider from either the experimental group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Communicating training group | Experimental | Behavioral: Expectancy-based communication training for healthcare providersHealthcare 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. |
| No training group | No intervention | –Healthcare providers in the control group receive no training but have the opportunity to receive the training after the study has been concluded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Expectancy-based communication training for healthcare providersAn 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. | Behavioural | Communicating training group |
Primary outcome
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.
1 secondary outcome
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
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 22 Sep 2026.
- Individual participant dataSharing planned: Yes. Shared IPD will consist of pseudonymized demographic data, questionnaire results and performance on training measurements.
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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.
Henriët van Middendorp, PhD principal investigator
Leiden University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expectancy-based communication training for healthcare providers in people with Rheumatic Diseases, run by Leiden University at 1 site in Netherlands.
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 8 inclusion and 0 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 Victor Leong, MSc. (6 46167311, o.v.leong@fsw.leidenuniv.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 22 Sep 2026.