- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05267197
3D Telemedicine: A Clinician Feedback Study
3D Telemedicine: Communication During Covid 19. A Clinician Feedback Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Scotland
-
Glasgow, Scotland, United Kingdom, G4 0SF
- Canniesburn Regional Plastic Surgery and Burns Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study population will consist of a mix of clinicians from Canniesburn Plastic Surgery Unit including:
- doctors
- nurses
- physiotherapists These clinicians will be at varying levels of seniority, age and will be gender balanced, to provide generalisability of the results
Description
Inclusion Criteria:
- clinicians in Canniesburn Plastic Surgery Unit
- doctors
- nurses
- physiotherapists
Exclusion Criteria:
- visual problems whereby participant is legally blind
- cannot consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
3D Telemedicine
Clinical consultation conducted with 3D Telemedicine
|
3D Telemedicine system
|
|
2D Telemedicine
Clinical consultation conducted with 2D Telemedicine
|
2D Telemedicine system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Satisfaction
Time Frame: 1 day (Single time point post study)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability Scale
Time Frame: 1 day (Single time point post study)
|
10 item industry standard technology scale, scores converted to a 0-100 scale.
Higher is better
|
1 day (Single time point post study)
|
|
Presence Questionnaire
Time Frame: 1 day (Single time point post study)
|
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)
|
|
Mental Effort Rating Scale
Time Frame: 1 day (Single time point post study)
|
Single instrument Likert scale rated 1-9.
Lower is better (Paas 1996)
|
1 day (Single time point post study)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GN20HS181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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