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临床试验/NCT06011356
NCT06011356进行中(未招募)不适用

Smart Watch Insights for Prevention of Exacerbations and Enhance Rehabilitation - Movement Study

Imperial College London1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
1
主要终点
Step count

研究概览

简要总结

Aims of the study:

  1. To deliver a scalable wellbeing programme to the local population of Imperial College Healthcare NHS Trust, focusing on movement.
  2. To describe the natural history of long-term conditions using digital data from a smartwatch.
  3. To identify digital information that is routinely collected by a smart watch that can be used to predict outcomes in patients with long term conditions.
  4. To identify factors that determine whether participants engage with and improve in a movement programme.

Adult patients who are registered to the Imperial NHS Care Information Exchange (CIE), an NHS patient-facing electronic health record, are eligible to participate in the study. Participants will receive a smart watch for self-monitoring of their movement and wellbeing and be asked to wear the device as much as possible. They will be asked to download a smartphone application called Connected Life, which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). Participants will receive secure login details for the Connected Life application from the research team, to ensure data privacy. The research team will look at participants' health records, and attempt to identify associations between the digital data and clinical information. This will allow the research team to identify digital data that predicts the onset and natural history of long term conditions, which may potentially allow for earlier diagnosis for future patients. The primary outcome of the study is the identification of trends in movement based on step-count data recorded by the smartwatch.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged over 18 years
  • Registered with the patient-facing electronic health record (Care Information Exchange)

排除标准

  • Unwilling or unable to provide informed consent
  • Arm or wrist injury or condition prohibiting the safe use of a smartwatch
  • Any visual impairment preventing the use of the smartwatch or smartphone application.

结局指标

主要结局

Step count

时间窗: 24 months

Change and trends in step count

次要结局

  • Patient Activation Measure (PAM)(24 months)
  • Quality of life (EQ-5D-5L)(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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