- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Control
Standard of care |
|
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Comparatore attivo: Intervention
Use of simulator |
Development of an online visual simulator, to allow accurate representation of visual symptoms |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patient survey scores
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Trainee survey
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- H26-01712
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .