3D Telemedicine During COVID-19: Non-clinical Validation
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Presence Questionnaire
研究概览
简要总结
Telemedicine will be used as standard practice during the Covid Pandemic, in order to reduce clinician exposure to patients and potential high viral load, and reduce patient footfall in a hospital caring for Covid patients. The 3D telemedicine uses multiple cameras in the clinic room which can reconstruct an image in 3 dimensions. This may give more information about a patient's condition, particularly in more visual specialties such as Plastic Surgery. The systems have hospital approval to be used for telemedicine, all equipment is CE marked. There are no data regarding the use of 3D telemedicine, but similar studies have been performed in many fields including orthopaedic surgery using 2D telemedicine (Buvik 2016). This study aims to provide non-clinical validations of the 3D telemedicine for usability, presence, satisfaction and reliability, using healthy volunteers only.
详细描述
Study Methods The study will involve non-clinical validation with no patients and no interventions. The study will investigate usability, presence, satisfaction and reliability data for 3D telemedicine, and provide subjective feedback in the form of a semi-structured interview.
Participants Healthy volunteers from the staff at Canniesburn Regional Plastic Surgery and Burns Unit, Glasgow Royal Infirmary and West Glasgow ACH, Greater Glasgow and Clyde.
Inclusions and exclusion Healthy staff/students. Recruitment from all contacted, eligible participants will be recorded. Exclusion criteria include visual problems not correctable with glasses/dyslexia.
Consent Participants will be consented in writing for inclusion in the study. The consent will specify that data may be recorded for research and further analysis by the research team, and be available for technical purposes by the research team's industrial partner
Sample Size
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator and outcomes assessor will be blinded to method of telemedicine. It is not possible to blind participants.
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers from staff at NHS GGC.
排除标准
- •visual problems not correctable with glasses
- •dyslexia.
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
University Hospital of North Northway Questionnaire
时间窗: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient)
5 item questionnaire on telemedicine quality. UNN Buvik 2016.
次要结局
- 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) ])
- 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) ])