NCT05267197

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
Last Updated

May 31, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

February 23, 2022

Last Update Submit

May 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • System Usability Scale

    1 day (Single time point post study)

  • Presence Questionnaire

    1 day (Single time point post study)

  • Mental Effort Rating Scale

    1 day (Single time point post study)

Study Arms (2)

3D Telemedicine

Clinical consultation conducted with 3D Telemedicine

Other: 3D Telemedicine

2D Telemedicine

Clinical consultation conducted with 2D Telemedicine

Other: 2D Telemedicine

Interventions

3D Telemedicine system

3D Telemedicine

2D Telemedicine system

2D Telemedicine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • clinicians in Canniesburn Plastic Surgery Unit
  • doctors
  • nurses
  • physiotherapists

You may not qualify if:

  • visual problems whereby participant is legally blind
  • cannot consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canniesburn Regional Plastic Surgery and Burns Unit

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Related Publications (1)

  • Lo S, Fowers S, Darko K, Spina T, Graham C, Britto A, Rose A, Tittsworth D, McIntyre A, O'Dowd C, Maguire R, Chang W, Young D, Hoak A, Young R, Dunlop M, Ankrah L, Messow M, Ampomah O, Cutler B; 3DTM (3D Telemedicine) Collaborative research group; Armstrong R, Lalwani R, Davison R, Bagnall S, Hudson W, Shepperd M, Johnson J. Participatory development of a 3D telemedicine system during COVID: The future of remote consultations. J Plast Reconstr Aesthet Surg. 2023 Dec;87:479-490. doi: 10.1016/j.bjps.2022.10.012. Epub 2022 Oct 13.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 4, 2022

Study Start

November 11, 2020

Primary Completion

December 16, 2020

Study Completion

December 16, 2020

Last Updated

May 31, 2022

Record last verified: 2022-02

Locations