[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657119":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":28,"studyPopulation":18,"armGroups":29,"interventions":40,"overallOfficials":46,"centralContacts":51,"locations":57,"responsibleParty":75,"collaborators":78,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":18,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":18,"enrollmentInfo":103,"targetDuration":18,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":59,"whyStopped":18,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"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.\n\nThe 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.",[14],{"measure":15,"description":16,"timeFrame":17},"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.\n\nThe 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",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","Participants consist of 52 healthcare providers and 884 patients.\n\nFor 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.\n\nThe patient population will include individuals who have had a consultation with a healthcare provider from either the experimental group or the control group.","SUPPORTIVE_CARE",{"masking":25,"maskingDescription":18,"whoMasked":26},"SINGLE",[27],"PARTICIPANT","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.\n\nAim: 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.\n\nMethod: 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).\n\nParticipants: Healthcare providers participating in the study must be active and working in the rheumatology department. Additionally, they must see patients on a regular basis.\n\nPatients must be 18 years or older and require a mastery of spoken and written Dutch.\n\nIntervention 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.\n\nThe 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.\n\nMain 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.\n\nThe secondary outcome will be determined by comparing the scores of the two groups on the validated patient-evaluation questionnaire 'QQPPI'.\n\nExploratory 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.\n\nAfter the conclusion of the study, the control group will be offered the same training as the intervention group.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"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.",[35],"Behavioral: Expectancy-based communication training for healthcare providers",{"label":37,"type":38,"description":39,"interventionNames":18},"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.",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":18},"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.",[31],[47],{"name":48,"affiliation":49,"role":50},"Henriët van Middendorp, PhD","Leiden University","PRINCIPAL_INVESTIGATOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":18,"email":56},"Victor Leong, MSc.","CONTACT","6 46167311","o.v.leong@fsw.leidenuniv.nl",[58],{"facility":49,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Leiden","South Holland","2333AK","Netherlands","NL",{"type":66,"coordinates":67},"Point",[68,69],4.49306,52.15833,{"lat":69,"lon":68},[72],{"name":73,"role":54,"phone":74,"phoneExt":18,"email":56},"Victor Leong, MSc","0646167311",{"type":50,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":49,"oldNameTitle":18,"oldOrganization":18},"hvanmiddendorp","Associate professor health & medical psychology",[79,80,82,84,86,88,90],{"name":5,"class":6},{"name":81,"class":6},"Reade Rheumatology Research Institute",{"name":83,"class":6},"Erasmus Medical Center",{"name":85,"class":6},"VieCuri Medical Centre",{"name":87,"class":6},"Medisch Spectrum Twente",{"name":89,"class":6},"Frisius Medisch Centrum",{"name":91,"class":92},"Dijklander Hospital, Hoorn and Purmerend, The Netherlands","UNKNOWN","100657119","effectiveness-of-a-combined-e-learning-and-virtual-reality-training-program-for-healthcare-providers-in-rheumatology-100657119",false,"NCT07835256","Effectiveness of a Combined e-Learning and Virtual Reality Training Program for Healthcare Providers in Rheumatology","Context Matters: Training Healthcare Professionals in Communication to Maximize Placebo Effects and Minimize Nocebo Effects in Rheumatology: A Multicentre, Randomized Controlled Trial.","Inclusion criteria for healthcare providers:\n\n* being 18 years or older\n* having a good command of the Dutch language, both written and spoken.\n* being a healthcare provider within the rheumatology department (e.g., rheumatologist, physician assistant, rheumatology nurse, medical resident, or medical researcher).\n* regularly seeing rheumatology patients during consultations.\n\nNo exclusion criteria, except for not having regular supervisory meetings with patients with rheumatic diseases.\n\nInclusion criteria for patients :\n\n* being 18 years or older\n* having a good command of the Dutch language, both written and spoken\n* having had a consultation with one of the participating healthcare providers (intervention or control group) within the past 8 weeks",true,"ALL","18 Years",{"count":104,"type":105},936,"ESTIMATED","INTERVENTIONAL",[108],"NA","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.\n\nThe main questions it aims to answer are:\n\n* Is communication training effective in increasing the self-perceived communication skills of the healthcare provider?\n* Is communication training effective in increasing the evaluation of patients on the communication skills of their corresponding healthcare provider?\n\nResearchers 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.\n\nParticipants 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.",[111],"Rheumatic Diseases",[113,114,115],"rheumatology","communication","placebo effects","2026-09-18",{"date":118,"type":119},"2026-09-22","ACTUAL",{"date":121,"type":119},"2025-03-27",{"date":123,"type":105},"2027-07",{"name":49,"class":6},1]