NCT04444323

Brief Summary

It is critical to establish an effective form of telemedicine during the Covid 19 pandemic, that will allow safe social distancing of clinicians and patients. Canniesburn Regional Plastic Surgery and Burns Unit serves as the regional plastic, burns and reconstructive centre for West of Scotland, population 3 million. All face to face clinics have been cancelled and converted to telephone/telemedicine only consultations. The research will establish both 2D and 3D telemedicine as normal patient follow up practice during this period.The project therefore aims to implement a 3D telemedicine system to facilitate patient follow up and remote physiotherapy, that will act as if the patient is physically 'present' in the room. Physiotherapy is crucial to patient outcomes after burns contractures, hand trauma and cancer reconstruction. The 3D telemedicine system will be built by an industrial partner, with CE marked equipment, specifically to help during the Covid-19 Pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

June 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

July 10, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

June 20, 2020

Last Update Submit

May 24, 2022

Conditions

Keywords

3-D

Outcome Measures

Primary Outcomes (1)

  • 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) ]

Secondary Outcomes (6)

  • University Hospital of North Northway Questionnaire

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

  • 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) ]

  • +1 more secondary outcomes

Other Outcomes (2)

  • Reliability

    Single time point at day 1 (whether telemedicine is successful)

  • Image distortion

    Single time point at day 1 (whether telemedicine has distortion)

Study Arms (1)

3D Telemedicine

EXPERIMENTAL

Single arm. All patient seen face-to-face and then with 3D telemedicine.

Other: 3D Telemedicine

Interventions

The intervention is a consultation conducted using a 3D form of telemedicine

3D Telemedicine

Eligibility Criteria

Age1 Year - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with breast cancer reconstruction
  • Patients with sarcoma
  • Patients with head \& neck reconstruction
  • Patients with flap reconstruction
  • Patients with limb reconstruction
  • Patients with hand trauma
  • Patients with burns
  • Patients with cleft lip
  • Patients able to read and understand English
  • Patients able to give informed consent

You may not qualify if:

  • Patients who do not have capacity to consent
  • Patients who are registered blind or deaf

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
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Data analysis will be masked
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single cohort patients seen face-to-face and then by 3D telemedicine
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2020

First Posted

June 23, 2020

Study Start

July 10, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

No plan to share data

Locations