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临床试验/NCT04444323
NCT04444323已完成不适用

3D Telemedicine During COVID-19: Cohort Study

NHS Greater Glasgow and Clyde2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Presence Questionnaire

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. Canniesburn Regional Plastic Surgery and Burns Unit serves as the regional plastic, burns and reconstructive centre for West of Scotland, population 3 million. All face to face clinics have been cancelled and converted to telephone/telemedicine only consultations. The research will establish both 2D and 3D telemedicine as normal patient follow up practice during this period.The project therefore aims 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.

详细描述

  1. Background:

Telemedicine is critical during Covid pandemic. A seismic shift in clinical practice has occurred in the UK, with nearly all medical clinics cancelled or converted to telephone or telemedicine clinics (Attend Anywhere or Zoom). These fail to adequately substitute for a face-to-face consultation, with the National Health Service (NHS) needing higher quality, more clinically effective methods of remote patient interaction. This project will be the world's first evaluation of a novel, potentially transformative form of 3D telemedicine, facilitating telepresence as if the patient were in the room. This state-of-the-art system has been developed by an industrial partner, specifically to help with remote patient communication during Covid pandemic. This uses an array of 3D cameras connected to fusion and render servers, allowing reconstruction of a 3D image in real time. This may give more information about a patient's condition, particularly in more visual specialties such as Plastic Surgery

The research will fulfil criteria for the European Commission's Model for Assessment of Telemedicine applications (MAST, Kidholm 2012). This will include participatory design, and evaluation with a preliminary cohort study, to shape the follow on research. This will assess clinicians' and patients' perception of system usability, delivery of therapies, clinical accuracy and interaction. On project completion, fulfilment of MAST criteria will enable upscaling and lead onto a randomized trial. The study design will be informed by participatory design prior to the start of the clinical study. This will include clinical stakeholders (specialist nurses, doctors and physiotherapists), the digital research team, and patient groups. The focus groups will collate user groups opinions about the 3D system, functionality, risks, and applicability.

The clinical study will be a feasibility study involving clinician and patient feedback on 3D telemedicine, and will additionally collect safety, reliability and fidelity data. The study will be a mixed methods analysis assessing measures of usability, satisfaction, presence, task load index, and accuracy. Clinicians and patients will complete questionnaires and undergo a short interview on the use of both forms of telemedicine. There are no data regarding the use of 3D telemedicine, but this will leverage study design and validated questionnaires from other similar studies (Buvik 2016). The study will continue as post covid services are being established. 2. Aims

This study will refine and pilot the feasibility of introducing 3D telemedicine into plastic surgery clinics and gain pilot data on the comparative efficacy and acceptability compared to face-to-face clinics, from both a patient and clinician perspective. The feasibility study will then inform the design and size of larger randomised study to compare 2D and 3D telemedicine. 3. Research Questions Primary

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

Data analysis will be masked

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

  • Patients with breast cancer reconstruction
  • Patients with sarcoma
  • Patients with head & neck reconstruction
  • Patients with flap reconstruction
  • Patients with limb reconstruction
  • Patients with hand trauma
  • Patients with burns
  • Patients with cleft lip
  • Patients able to read and understand English
  • Patients able to give informed consent

排除标准

  • Patients not meeting the inclusion criteria
  • Patients who do not have capacity to consent
  • Patients who are registered blind or deaf

结局指标

主要结局

Presence Questionnaire

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

Version 3 of PQ, 29 item rating scale of "presence". Witmer 2005

次要结局

  • University Hospital of North Northway Questionnaire(Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ])
  • Telehealth Usability Questionnaire(Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ])
  • System Usability Scale(Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ])
  • Mental Effort Rating Scale(Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ])
  • NASA TLX(Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ])
  • Range of Motion measurements for elbow joint(Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ])

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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