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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05267197
Other study ID # GN20HS181
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 11, 2020
Est. completion date December 16, 2020

Study information

Verified date February 2022
Source NHS Greater Glasgow and Clyde
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The use of Telemedicine has increased significantly due to constraints imposed by the Covid pandemic. 3D telemedicine uses multiple cameras in the clinic room which can reconstruct an image in 3 dimensions in real-time, which may be beneficial in more visual focused specialties such as Plastic Surgery. There are no clinical data regarding the use of 3D telemedicine, with previous studies laboratory based without clinicians or patients. This study aims to provide clinician data comparing 3D and 2D Telemedicine, and feedback to allow incremental improvement of the system prior to clinical trials involving patients.


Description:

Aims The aim of this study is to assess 3D telemedicine and 2D telemedicine from the clinician's perspective, to optimise the system prior to clinical trials with patients. This will provide baseline validated outcome data on areas such as usability, presence (the realism or immersion of a system), mental effort and task load. "Keep, Lose and Change" prompts will be used to aid improvements in the 3D Telemedicine system prior to clinical trials. Participants This will be a clinician feedback based study on 2D telemedicine and 3D telemedicine. Clinicians will include nurses, doctors and physiotherapists from Canniesburn Plastic Surgery Unit, Glasgow, UK. Consent Clinicians will consent in writing to participate Method Clinicians will use both 3D and 2D Telemedicine systems to examine a member of the research team who will act as a "patient". There will be a single clinician (consultant, nurse specialist or physiotherapist) examining the patient during the clinic.They will use each system for 10 minutes each. No randomisation will take place. This will be followed by a questionnaire which will be filled in once per patient by the clinician in the clinic. Outcome measures No primary or secondary measures are specified as this is an observational feedback study, not an interventional clinical trial. Satisfaction - Visual Analogue Scale 0-100 Mental Effort Rating Scale - single instrument Likert scale (Paas 1996) System Usability Scale - 10 item industry standard technology scale Presence Questionnaire - 29 item scale - assessment of presence in the system/virtual environment (PQ, Witmer 2005). Semi Structured exit interview - will discuss with participant their views on the telemedicine system, using "Keep, Lose and Change" prompts to aid system improvements.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date December 16, 2020
Est. primary completion date December 16, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - clinicians in Canniesburn Plastic Surgery Unit - doctors - nurses - physiotherapists Exclusion Criteria: - visual problems whereby participant is legally blind - cannot consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
3D Telemedicine
3D Telemedicine system
2D Telemedicine
2D Telemedicine system

Locations

Country Name City State
United Kingdom Canniesburn Regional Plastic Surgery and Burns Unit Glasgow Scotland

Sponsors (3)

Lead Sponsor Collaborator
NHS Greater Glasgow and Clyde Microsoft Corporation, University of Strathclyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Satisfaction Satisfaction measured on a Visual Analogue Scale between 0-100. Higher is better (Voutilainen et al. 2016). 1 day (Single time point post study)
Secondary System Usability Scale 10 item industry standard technology scale, scores converted to a 0-100 scale. Higher is better 1 day (Single time point post study)
Secondary Presence Questionnaire 29 item scale - assessment of presence in the system/virtual environment. Score 0-203, Higher is better (PQ, Witmer 2005). 1 day (Single time point post study)
Secondary Mental Effort Rating Scale Single instrument Likert scale rated 1-9. Lower is better (Paas 1996) 1 day (Single time point post study)
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