An interventional study of Expectancy-based communication training for healthcare providers in Rheumatic Diseases, sponsored by Leiden University. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Leiden University · Not applicable, Interventional, and Supportive care
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:
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.
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.
264 studies on the registry are indexed under Rheumatic Diseases; 60 are open to participants now.
This study's planned enrollment of 936 is above the median of 100 across 167 interventional studies indexed under Rheumatic Diseases.
Browse Rheumatic Diseases studies →Leiden University is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for healthcare providers:
No exclusion criteria, except for not having regular supervisory meetings with patients with rheumatic diseases.
Inclusion criteria for patients :
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
Healthcare providers in the control group receive no training but have the opportunity to receive the training after the study has been concluded.
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.
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.
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.
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'.
Time frame: Patient-evaluations will be collected over the course of eight weeks after completing the communication training by healthcare providers
Plan to share: Yes — Shared IPD will consist of pseudonymized demographic data, questionnaire results and performance on training measurements.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data will become available after publication of the study and remain available for 10 years.
Access criteria: The data will be securely restricted and access will be granted upon request to the author for research purposes.
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Apr 2027, 25 months after the start.
Of 72 non-industry interventional studies with no phase under Rheumatic Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 25 months is close to that.
Counting every sponsor, half of 74 studies reached it within 26 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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