跳至主要内容
临床试验/NCT04933786
NCT04933786已完成不适用

Digital Health Nudging - Daily Smartphone Messages to Increase Physical Activity in Adolescents With Congenital Heart Disease

Deutsches Herzzentrum Muenchen2 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
97
试验地点
2
主要终点
Objectively measured physical activity

研究概览

简要总结

In adolescents with congenital heart disease physical activity level is reduced which is why promotion to a more active lifestyle with an age-appropriate and modern intervention is needed. In healthy subjects digital health nudging was shown to increase physical activity. However, in adolescents with congenital heart disease such studies have not been conducted yet. In this RCT participants receive daily, short smartphone messages with the primary purpose to increase daily physical activity, which is monitored with a "Garmin vivofit jr." wearable.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Adolescents aged 12 to 18 years inclusive
  • Presence of a congenital heart defect (must be moderate or complex according to ACC criteria)
  • Presence of written informed consent

排除标准

  • Cognitive impairments that inhibit patients from understanding the tasks

结局指标

主要结局

Objectively measured physical activity

时间窗: 25 weeks

Physical activity is objectively assessed with the wrist worn wearable "Garmin vivofit jr.". Daily physical activity is measured on the basis of active minutes in moderate-to-vigorous intensity.

次要结局

  • Objectively measured daily step count(25 weeks)
  • Activity-related self-efficacy(Baseline, after 12 weeks, after 24 weeks)
  • Health-related quality of life(Baseline, after 12 weeks, after 24 weeks)

研究者

发起方
Deutsches Herzzentrum Muenchen
申办方类型
Other
责任方
Sponsor

研究点 (2)

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