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临床试验/NCT05829252
NCT05829252已完成不适用

Testing the Feasibility of a Novel Growth Monitoring Smartphone App

Queen Mary University of London1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2021年3月18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
146
试验地点
1
主要终点
Reliability

研究概览

简要总结

The goal of this clinical trial is to test the acceptability, feasibility, accuracy and precision of the 'GrowthMonitor' smartphone app in a pilot population.

详细描述

The GrowthMonitor app will calculate height data using smartphone images of children taken by parents or carers in the home at two or more set time points. The app will convert height data from the image to a numerical height measurement in centimeters and this will be transferred to a central database hosted on a secure UK based server with additional relevant demographic data (gender, ethnicity, weight, date of birth, and parents' height).

The height and demographic data are transferred with an anonymous identifier to a GDPR-approved secure database on a UK based server. Critically, patient images and children's names will not be transferred, and only authorized users will have access to the data stored within the secure database.

The app will display a virtual growth chart providing the patient with a digital history of the child's growth over time. BMI will also be calculated and plotted on an age- and gender-appropriate chart. Ultimately, users of the app will need to create an account using a username (email address) and password. We will use their email address so that password resets can be sent along with reminders or alerts about their account.

Child's height in relation to his/her parental heights as well as longitudinal growth data will be analyzed within the secure UK based web server using existing growth monitoring algorithms.

  1. Height compared to population-based height references (HSDS)
  2. Distance from target height (calculated from parental heights, THSDSDEV)
  3. HSDS change over time (ΔHSDS) -when more than one height measurement is available (taken >6 months apart)

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children and young people (male and female) aged 1-18 yr receiving height measurements as part of their routine / prearranged attendance to a paediatric endocrinology or other paediatric out-patient appointment at Barts Health Trust.
  • Participants require a smartphone to take part in the study.

排除标准

  • Children under the age of 1 years
  • Young people aged 16-18yr who lack capacity to consent
  • Other individuals unable to reliably stand for an accurate height measurement e.g.
  • individuals with severe disability and/or confined to a wheelchair

结局指标

主要结局

Reliability

时间窗: At baseline

Inter- and intra-rater reproducibility of the GrowthMonitor app

Agreement

时间窗: At baseline

Agreement between the GrowthMonitor app and wall-fixed stadiometer

次要结局

  • Usability(At 1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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