3D Telemedicine During COVID-19: Non-clinical Validation

NCT04444297 | Unknown

• 1 other identifier: GN20HS287
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Telemedicine will be used as standard practice during the Covid Pandemic, in order to reduce clinician exposure to patients and potential high viral load, and reduce patient footfall in a hospital caring for Covid patients. The 3D telemedicine uses multiple cameras in the clinic room which can reconstruct an image in 3 dimensions. This may give more information about a patient's condition, particularly in more visual specialties such as Plastic Surgery. The systems have hospital approval to be used for telemedicine, all equipment is CE marked. There are no data regarding the use of 3D telemedicine, but similar studies have been performed in many fields including orthopaedic surgery using 2D telemedicine (Buvik 2016). This study aims to provide non-clinical validations of the 3D telemedicine for usability, presence, satisfaction and reliability, using healthy volunteers only.

Conditions

Telemedicine; Surgery, Plastic

Keywords

3-D

Outcome Measures

Primary Outcomes (2)

• Presence Questionnaire

  Version 3 of PQ, 29 item rating scale of "presence". Witmer 2005

  Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]

• University Hospital of North Northway Questionnaire

  5 item questionnaire on telemedicine quality. UNN Buvik 2016.

  Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient)

Secondary Outcomes (5)

• Telehealth Usability Questionnaire

  Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]

• System Usability Scale

  Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]

• Mental Effort Rating Scale

  Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]

• NASA TLX

  Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]

• Range of Motion measurements for elbow joint

  Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]

Study Arms (2)

2D telemedicine

ACTIVE COMPARATOR

2D telemedicine first, followed by crossover to 3D telemedicine with no washout period

Other: 2D Telemedicine

3D Telemedicine

EXPERIMENTAL

3D telemedicine first, followed by crossover to 2D telemedicine with no washout period

Other: 3D Telemedicine

Interventions

3D Telemedicine OTHER

A consultation performed with a 3D form of telemedicine

3D Telemedicine

2D Telemedicine OTHER

A consultation performed with 2D (standard) telemedicine

2D telemedicine

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers from staff at NHS GGC.

You may not qualify if:

• visual problems not correctable with glasses
• dyslexia.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Jean Brown Bequest Fund, Glasgow, UK: collaborator

Study Sites (1)

Canniesburn Regional Plastic Surgery and Burns Unit

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes assessor will be blinded to method of telemedicine. It is not possible to blind participants.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised to 2D then 3D, or 3D then 3D telemedicine consultations

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: September 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)