NCT02632383已完成不适用
Young With Diabetes Type 1 - Test of an mHealth App
Nordsjaellands Hospital12 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2015年12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
- 140
- 试验地点
- 12
- 主要终点
- Glycemic control measured by HbA1c
研究概览
简要总结
A multicenter randomized controlled trial testing the app "Young with Diabetes"
详细描述
Young people with diabetes type 1, their parents and health care providers have participated in developing the mHealth app "Young with Diabetes".
The aim of the app is to support young people to self-manage their diabetes type 1.
A test group of 70 young people with diabetes type 1 test the app for 12 months as a supplement to standard care and the control group receives standard care only.
At baseline and after 2, 7 and 12 months HbA1c, problem areas in diabetes, perceived competences in diabetes and health care climate are measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes
- •14 to 22 years old
- •followed at one of the six diabetes departments/centers
- •Pediatric and Adolescent Department, Nordsjællands Hospital, Hillerød
- •Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød
- •Pediatric and Adolescent Department, Herlev Hospital
- •Steno Diabetes Center, Gentofte
- •Pediatric Department, Roskilde Hospital
- •Department of Endocrinology, Køge Hospital
- •have an iOS or android smartphone
- •last measured HbA1c before sending out recruiting letters: 64 mmol/mol or more (if the last measured HbA1c is older than 6 months at time of baseline visit a new HbA1c is measured and has to be at least 64 mmol/mol before the participant kan be randomized)
- •mean of the three last measured HbA1c before sending out recruiting letters: 58 mmol/mol or more (if the third last HbA1c is older than 18 months at time of baseline visit a new HbA1c is measured and has to be at least 64 mmol/mol before the participant kan be randomized)
排除标准
- •A psychical or psychiatric disorder that enables them to use the app
- •Participates in other diabetes interventions
- •Sees a psychologist or psychiatrist
- •Have participated in developing the app Young with Diabetes
结局指标
主要结局
Glycemic control measured by HbA1c
时间窗: Glycemic control is measured by HbA1c at 12 months
次要结局
- Problem areas in diabetes measured by PAID-20(Problem areas in diabetes are measured by PAID-20 at 12 months)
- Perceived competences in diabetes measured by PCD-questionnaire(Perceived competences in diabetes are measured by PCD-questionnaire at 12 months)
- Health Care Climate measured by HCCQ-questionnaire(Health Care Climate is measured by HCCQ-questionnaire at 12 months)
研究者
研究点 (12)
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