Clinical Trial of 3D Telemedicine

NCT05227235 | Unknown

• 1 other identifier: INGN22SG035
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This randomised controlled trial will provide definitive answers to whether a 3D telemedicine system makes a remote consultation more similar to meeting a doctor face-to-face, than a 2D Telemedicine consultation. This will be measured using a "Presence" scale - which is a measure of the realism or immersion of the system - and is of key importance as preliminary data from the research team's feedback studies found that realism of a clinical consultation correlates strongly with patient satisfaction. Patient satisfaction is seen by many healthcare systems as primary evidence of efficacy of treatment and as a strong determinant of overall health outcomes. Further outcome measures in this trial will assess patient satisfaction, usability, and mental effort.

Conditions

Telemedicine; Surgery

Outcome Measures

Primary Outcomes (1)

• Single Item Presence Questionnaire

  This will ask patients the question "To which extent did you feel present in the virtual clinic, as if you were really there?". This is a single item evaluation of presence validated by Bouchard et al 2004.

  1 day (Single time point post randomization)

Secondary Outcomes (4)

• Telehealth Usability Questionnaire

  1 day (Single time point post randomization)

• Patient Satisfaction

  1 day (Single time point post randomization)

• Mental Effort Rating Scale

  1 day (Single time point post randomization)

• Glasgow Telemedicine Scale.

  1 day (Single time point post randomization)

Study Arms (2)

3D Telemedicine

EXPERIMENTAL

3D Telemedicine system allowing patient to be seen in 3 dimensions

Other: 3D Telemedicine

2D Telemedicine

ACTIVE COMPARATOR

2D Telemedicine system allowing patient to be seen in standard video call

Other: 2D Telemedicine

Interventions

3D Telemedicine OTHER

Clinical consultation with patient performed with 3D Telemedicine

Also known as: Telepresence

3D Telemedicine

2D Telemedicine OTHER

Clinical consultation with patient performed with 2D Telemedicine as standard of care

Also known as: Traditional Telemedicine

2D Telemedicine

Eligibility Criteria

• Age: 16 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have undergone a plastic surgery procedure including:
• free flap reconstruction
• pedicled flap reconstruction
• skin graft reconstruction
• major cancer surgery
• major trauma and burns surgery
• 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
• Patients undergoing minor operations only including:
• primary closure
• minor local flap reconstruction (for example minor surgery for benign lesions or low risk tumours including Basal or Squamous Cell Carcinoma)
• minor hand surgery not requiring major flap reconstruction (for example nail bed repair, digital nerve repair, infections).
• Patients with perineal reconstruction given the sensitive area of examination

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Strathclyde: collaborator
• Microsoft Corporation: 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: Due to the nature of Telemedicine it is not possible to blind the participant (patient) or the care provider (clinician performing consultation). The investigator and outcomes assessor will be blinded, with group allocation blinded.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will use a combination of within-subjects design (crossover) and between-subjects design (standard randomised controlled trial with 2 arms).

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 7, 2022
• Study Start: August 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)