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临床试验/NCT04359225
NCT04359225Unknown不适用

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

NHS Greater Glasgow and Clyde2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年9月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Mental effort rating scale

研究概览

简要总结

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)

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Patient will be blinded to form of telemedicine. Clinician will not be blinded

入排标准

年龄范围
1 Year 至 95 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Adults unable to consent
  • Patients requiring interpreter.

结局指标

主要结局

Mental effort rating scale

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

Scale 1 to 9 Higher score is worse

University Hospitals of North Northway questionnaire

时间窗: 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

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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