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.
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.
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
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?
- 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.
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 3D telemedicine | Active comparator | 3D telemedicine system Receives: Other: 3D Telemedicine |
| 2D telemedicine | Placebo comparator | 2D 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.
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)
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)
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)
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.
- First posted24 Apr 2020
- Study start30 Sep 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelehealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Strathclyde, Glasgow Royal Infirmary
- Responsible party
- Sponsor
- Investigators
- Steven Lo, FRCS Plast, Principal investigator, NHS Greater Glasgow and Clyde Clinical Research and Development Central Office
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of 3D and 2D Telemedicine: Communication During Covid 19
- ClinicalTrials.gov ID
- NCT04359225
- Acronym / sponsor ID
- GN20HS182
- Conditions
- Telehealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Strathclyde, Glasgow Royal Infirmary
- Study start
- 30 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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?
- 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.
- 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.
- 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.
- 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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| 3D telemedicine | Active comparator | Other: 3D Telemedicine3D telemedicine system |
| 2D telemedicine | Placebo comparator | Other: 2D Telemedicine2D telemedicine system (standard care) |
Who may qualify
- Ages
- 1 year to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Adults unable to consent
- Patients requiring interpreter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D TelemedicineAlso: TelepresenceTelemedicine using 3D broadcast to clinician | Other | 3D telemedicine |
| 2D TelemedicineAlso: Standard CareStandard care with 2D telemedicine | Other | 2D telemedicine |
Primary outcome
University Hospitals of North Northway questionnaire
Time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient)
University Hospitals of North Northway questionnaire. Outcome scale with a sum score 1 to 5 Higher score is worse
Mental effort rating scale
Time frame: Single time point at day 1(Clinician assesses telemedicine system once after seeing patient)
Scale 1 to 9 Higher score is worse
2 secondary outcomes
Telehealth Usability Questionnaire
Time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient)
Subjective feedback interview
Time frame: Once at study completion, an average of 18 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Lo, FRCS Plast principal investigator
NHS Greater Glasgow and Clyde Clinical Research and Development Central Office
1 site in 1 country: see every site and its status.
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.