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TelehealthNCT04359225

A Comparison of 3D and 2D Telemedicine During Covid 19

A study testing 3D Telemedicine and 2D Telemedicine in people with Telehealth, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 95 years
Conditions the study is for
Telehealth
What is being tested?
3D Telemedicine and 2D Telemedicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteUnited Kingdom
Study dates
30 Sep 2021to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 95 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Adults unable to consent
  • Patients requiring interpreter.

Trial locations and contacts

1 site in 1 country.

Steven Lo, FRCS Plast contact

01412114475

steven.lo@nhs.net

David McGill, FRCS Plast contact

01412114000

david.mcgill@ggc.scot.nhs.uk

United Kingdom1 site
  • Canniesburn Regional Plastic Surgery and Burns Unit

    Glasgow, Scotland, G4 0SF

    Steven Lo, FRCS Plast, 0141 2114000 ext. 4475, steven.lo@nhs.net

    David McGill, FRCS Plast, 0141 211 4000

Other trials in United Kingdom

About this study

Official title: A Comparison of 3D and 2D Telemedicine: Communication During Covid 19

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)

Read the detailed description

During Covid pandemic the Canniesburn Plastic Surgery Unit has stopped face to face clinics. The investigators therefore aim to assess current telemedicine options from a clinician viewpoint.

Why is the 3D telemedicine study important during Covid 19?

  1. Augment not replace current telemedicine capabilities. 3D telemedicine system would be transformative - much of Plastic Surgery work is 3 dimensional e.g. burns contractures, cleft lip. A 3D system may therefore give clinicians a more 'realistic' and accurate representation of patient interaction.
  2. Reduce viral load in clinic. This will reduce face to face contact. High viral load transmission (eg in the confines of an all day clinic) may be associated with higher risk of healthcare worker mortality.
  3. Facilitate remote therapies and improve patient outcomes. Current 2D telemedicine (e.g. Attend Anywhere) is limited in the ability to remotely guide patient therapies - the therapist cannot guide the camera or look at specific areas of interest. With 3D telemedicine the therapist can 'walk around' the patient as if the patient were co-present, and look at areas of interest with ease.
  4. Measurements of angles/other clinical measurements. For example, after a burns contracture or hand trauma a clinician may want to measure the angles at the wrist joint to see if there is any improvement. This cannot be done accurately with 2D telemedicine. 3D telemedicine may facilitate the measurement of angles and assess outcomes but this is unknown.

Method Randomised Controlled Trial. Single blinded (participants blinded - unaware of type of telemedicine, clinicians unblinded - aware of type of telemedicine)

Study setting and Participants:

The study will review clinician's assessments of telemedicine and clinical assessment of patients using telemedicine. These will consist of the plastic surgery patients selected from general plastic surgery clinic including patients with breast reconstruction, sarcoma, limb reconstruction, head \& neck reconstruction, flap reconstruction, hand trauma and cleft lip, and will be known to the research team. The assessment is of the telemedicine system by the clinician only. There will be two sites, the 'remote' site where the patient attends, and the 'central' site where the clinician reviews the patient. Remote site will be at West Glasgow Ambulatory Care Hospital (Covid free site) and the central location will be Glasgow Royal Infirmary.

Outcomes The investigators aim to answer the question "How does 3D telemedicine compare to 2D telemedicine?"

Primary outcomes:

Mental Effort Rating Scale, University Hospital of North Norway (UNN) scales, Telehealth Usability Questionnaire (TUQ)

Secondary outcomes:

Subjective feedback with transcribing, coding and thematic analysis. Measurements (where applicable e.g. angles of contracture in hand) Outcome scoring scales (where applicable e.g. validated Unilateral Cleft Score Surgical Outcomes Evaluation Scale - UCLSOE).

Study Methods:

Sample Size The pilot/feasibility study will generate data for sample size calculation. No data exist for sample size calculations of 3D versus 2D telemedicine.

Randomisation Block randomisation. Patient randomised to 2D or 3D telemedicine first.

Patient assessment with Telemedicine The patient is examined with the randomly allocated type of telemedicine and the duration of consultation recorded. The telemedicine room is the same for both 2D and 3D telemedicine, and uses the same equipment. After the consultation the patient does not require further participation

Clinician Feedback The clinician fills in a questionnaire assessment of the type of telemedicine used.

Clinician records measurements where applicable Clinician records outcome scoring scales where applicable

Primary outcomes UNN questionnaire Mental Effort Rating Scale

Secondary outcomes Telehealth Usability Questionnaire Subjective interview Patient measurements (where applicable) Patient outcome scales (where applicable)

Conditions
Telehealth
Being tested
3D Telemedicine, 2D Telemedicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D TelemedicineOther

    Also called Telepresence

    Telemedicine using 3D broadcast to clinician

  • 2D TelemedicineOther

    Also called Standard Care

    Standard care with 2D telemedicine

Study groups in NCT04359225
Study groupRoleWhat they receive
3D telemedicineActive comparator3D telemedicine system
Receives: Other: 3D Telemedicine
2D telemedicinePlacebo comparator2D telemedicine system (standard care)
Receives: Other: 2D Telemedicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. Mental effort rating scale

    Scale 1 to 9 Higher score is worse

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

Secondary outcomes (2)
  1. Telehealth Usability Questionnaire

    Telehealth Usability Questionnaire. 21 domains, each with scale 1 to 7. Higher is better.

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

  2. Subjective feedback interview

    Clinician Subjective feedback. This is an interview performed by a psychologist and will be transcribed, coded and thematically analysed. There is no statistical analysis or outcome scale involved.

    Measured: Once at study completion, an average of 18 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start30 Sep 2021 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Randomised controlled trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04359225
Sponsor's protocol ID
GN20HS182
Status last verified
Jun 2021
First submitted
16 Apr 2020
Last updated
8 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 3D Telemedicine and 2D Telemedicine in people with Telehealth, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Steven Lo, FRCS Plast (01412114475, steven.lo@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

University Hospitals of North Northway questionnaire (time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.

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