- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07914998
Visual Symptom Simulator (Vis_Sym_Sim)
A Web-based Visual Symptom Simulator as an Adjunct to Neuro-ophthalmologic Evaluation
Some patients presenting with visual symptoms may have difficulty accurately describing their visual experiences. Symptoms such as blurred vision, diplopia, visual field deficits, and transient visual disturbances are subjective and can be challenging to communicate using words alone. This can create communication barriers and contribute to variability in symptom interpretation, with potential implications for reduced patient satisfaction and uncertainty in clinical evaluation, especially among medical trainees.
This prospective, survey-based feasibility and usability study will have the primary objective of evaluating whether a visual symptom simulator (VSS) improves communication of visual symptoms during neuro-ophthalmology assessment compared with standard history-taking alone, and whether it can be feasibly integrated into routine clinical practice as an adjunct to standard history-taking.
Secondary objectives include: 1) assessing whether the use of a visual simulator improves the clarity of patient-reported visual symptoms and reduces ambiguity during clinical assessment; and 2) exploring its potential role in improving trainees' (medical students, residents, fellows) understanding and interpretation of subjective visual symptoms in neuro-ophthalmology.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Research design and methods In collaboration with BCIT, a web-based VSS platform will be developed, with the goal of presenting interactive visual symptom scenarios designed to simulate patient-reported visual experiences.
Participants will include patients 18 years or older who are referred to the Ophthalmology Clinic at St Paul's Hospital (SPH) and Vancouver General Hospital (VGH) Eye Care Center for assessment of one of the following visual complaints: transient visual loss, diplopia, or blurry vision. We will also recruit medical trainees rotating through neuro-ophthalmology services. A control group (standard of care) will be recruited first and will undergo standard clinical interview and neuro-ophthalmological assessment without the VSS. Following finalization of the VSS, patients will be recruited into the VSS intervention group.
Methods of analysis, instruments, and tools The VSS will be the primary intervention tool in the intervention group and will be delivered via a web-based platform. The control group will undergo the standard neuro-ophthalmological examination alone.
Data will be collected using post-clinical and post-intervention surveys completed by both patients and trainees. Surveys primarily consist of Likert-scale items assessing patient satisfaction, as well as trainees' perceived understanding of patient symptoms and confidence in clinical reasoning. A short section at the end of the questionnaires will be available to patients and trainees for qualitative feedback.
Quantitative data will be analyzed using descriptive statistics to compare outcomes between control and intervention groups. Where applicable, subgroup analyses may be performed based on level of training (trainees).
Qualitative data from open-ended survey responses will be reviewed and analyzed for recurring themes.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18 years or older
- Referred for neuro-ophthalmology evaluation with assessment of one of the following visual complaints: transient visual loss, diplopia, or blurry vision.
Exclusion Criteria:
- Younger than 18 years
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control
Standard of care |
|
|
Comparateur actif: Intervention
Use of simulator |
Development of an online visual simulator, to allow accurate representation of visual symptoms |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient survey scores
Délai: Immediately, at the completion of the patient first clinical assessment
|
Outcome survey will include rating scales of: Overall participant experience, Participant perception of physician understanding, Participant ability to communicate symptoms, Perceived influence on treatment/follow-up/care |
Immediately, at the completion of the patient first clinical assessment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Trainee survey
Délai: Immediately, at the completion of the patient consultation
|
Outcomes include survey ranking of: Overall Educational Value and Trainee rating of VSS educational usefulness |
Immediately, at the completion of the patient consultation
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- H26-01712
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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