NCT04359225

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. The investigators serve as the regional plastic, burns and reconstructive centre for the West of Scotland, population 3 million. All face to face clinics have been cancelled and converted to telephone/telemedicine only consultations. The investigators will establish both 2D and 3D telemedicine as normal patient follow up practice during this period. The aim is 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. This study forms a follow on study to the investigator's pilot study (based on clinical feedback only)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

April 16, 2020

Last Update Submit

June 4, 2021

Conditions

Telehealth

Outcome Measures

Primary Outcomes (2)

  • University Hospitals of North Northway questionnaire

    University Hospitals of North Northway questionnaire. Outcome scale with a sum score 1 to 5 Higher score is worse

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

  • Mental effort rating scale

    Scale 1 to 9 Higher score is worse

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

Secondary Outcomes (2)

  • Telehealth Usability Questionnaire

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

  • Subjective feedback interview

    Once at study completion, an average of 18 months.

Study Arms (2)

3D telemedicine

ACTIVE COMPARATOR

3D telemedicine system

Other: 3D Telemedicine

2D telemedicine

PLACEBO COMPARATOR

2D telemedicine system (standard care)

Other: 2D Telemedicine

Interventions

3D TelemedicineOTHER

Telemedicine using 3D broadcast to clinician

Also known as: Telepresence
3D telemedicine
2D TelemedicineOTHER

Standard care with 2D telemedicine

Also known as: Standard Care
2D telemedicine

Eligibility Criteria

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

You may qualify if:

  • Breast reconstruction patients pre and post op
  • Sarcoma patients pre and post op
  • Burns patients pre and post op
  • Cleft lip patients pre and post op
  • Head \& neck reconstruction patients pre and post op
  • Hand trauma patients pre and post op
  • Flap reconstruction patients pre and post op.

You may not qualify if:

  • Adults unable to consent
  • Patients requiring interpreter.

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

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Steven Lo, FRCS Plast

    NHS Greater Glasgow and Clyde Clinical Research and Development Central Office

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Lo, FRCS Plast

CONTACT

01412114475steven.lo@nhs.net

David McGill, FRCS Plast

CONTACT

01412114000david.mcgill@ggc.scot.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Patient will be blinded to form of telemedicine. Clinician will not be blinded
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 24, 2020

Study Start

September 30, 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)