NCT07835256

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
936

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Mar 2025Jul 2027

Study Start

First participant enrolled

March 27, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 22, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 27, 2026

Last Update Submit

September 18, 2026

Conditions

Keywords

rheumatologycommunicationplacebo effects

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    Patient-evaluations will be collected over the course of eight weeks after completing the communication training by healthcare providers

Study Arms (2)

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.

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.

Interventions

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.

Communicating training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University

Leiden, South Holland, 2333AK, Netherlands

RECRUITING

MeSH Terms

Conditions

Rheumatic DiseasesCommunication

Interventions

Health Personnel

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

  • Henriët van Middendorp, PhD

    Leiden University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Leong, MSc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor health & medical psychology

Study Record Dates

First Submitted

July 27, 2026

First Posted

September 22, 2026

Study Start

March 27, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations