Evaluation of an Early Screener to Identify Long-term Problems With Regard to Metabolic Control and Treatment Adherence Among Children and Adolescents With Type 1 Diabetes
Background: Type 1 diabetes is one of the most common chronic illnesses among children and adolescents. Although, intensive medical care is provided for these patients, some of them have poor metabolic control. For example, only 21% of adolescents with type 1 diabetes in the USA achieve the recommended average blood sugar concentration (HbA1c<7.5%). This is a major problem, since chronic hyperglycemia is the primary cause of morbidity and mortality in type 1 diabetes and causes several serious complications, for example kidney failure, blindness, and stroke. Therefore, the International Society for Pediatric and Adolescent Diabetes (ISPAD) declared psychosocial factors, to be the most important risk factors of poor type 1 diabetes Management. Therefore, an instrument is needed to identify children and adolescents with poor metabolic control in their course of disease as soon as possible. With an early identification of such risk patients, better support can be provided. However, there is no such instrument yet for pediatric patients with type 1 diabetes. To fill this gap, a questionnaire (FEPB) based on the PAT 2.0© (Psychosocial Assessment Tool; an instrument used in oncology) was developed for this project.
Aim: The aim of this project is to evaluate and validate a new instrument (FEPB) for an early identification of children and adolescents with poor metabolic control in their course of disease in a longitudinal design.
Method: The sample consists of children and adolescents (age: 5-18 years), who were newly diagnosed with type 1 diabetes (2-4 weeks ago), and who are in care at the University Children's Hospital of Zurich. Structured interviews are conducted with the patients and the parents are asked to fill out some questionnaires at two times: first, 2-4 weeks after the diagnosis (T1) and second 6 month later (T2). With the new instrument (FEPB) a risk score can be calculated for each patient at T1. Statistical analysis will be performed to determine whether that risk score can predict which patients have poor metabolic control (HbA1c > 7.5%) at T2.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Zürich、瑞士
- University Children's Hospital Zurich
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- diagnosed with type 1 Diabetes 2-4 weeks ago
- in care at the University Children's Hospital of Zurich
- German speaking
Exclusion Criteria:
- other severe illness that affects the diabetes Management
- severe developmental disorder
- pregnancy
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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糖化血红蛋白
大体时间:10分钟
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糖化血红蛋白
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10分钟
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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与健康相关的生活质量(慢性通用指标)
大体时间:5分钟
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通过问卷评估:DISABKIDS 慢性通用测量 - 简短版(DCGM-12;欧洲 DISABKIDS 集团,2012 年)。 总分范围:12-60。 得分越高,与健康相关的生活质量越高。 |
5分钟
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与健康相关的生活质量(糖尿病模块)
大体时间:5分钟
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通过问卷评估:DISABKIDS 糖尿病模块(The European DISABKIDS Group,2012)。 总分范围:10-50。 得分越高,与健康相关的生活质量越高。 |
5分钟
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心理健康(抑郁症)
大体时间:10分钟
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通过问卷评估:德国版儿童抑郁量表(Depressionsinventar für Kinder und Jugendliche [DIKJ];Stiensmeier-Pelster、Braune-Krickau、Schürmann & Duda,2014 年)。 总分范围:0-58。 分数越高,参与者越抑郁。 |
10分钟
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心理健康(特质焦虑)
大体时间:5分钟
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通过问卷评估:德文版儿童特质焦虑量表(Trait Angstinventar für Kinder [STAIK-T];Unnewehr、Joormann、Schneider & Margraf,1992)。 总分范围:20-60。 得分越高,特质焦虑程度越高。 |
5分钟
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psychological health (Child Behavior)
大体时间:10 minutes
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Assessed by questionnaire: German Version of the Child Behavior Checklist (CBCL 6-18R; Döpfner, Plück & Kinnen, 2014) Total score range: 0-224.
The higher the score, the more behavioral problems.
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10 minutes
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合作者和调查者
调查人员
- 首席研究员:Markus A Landolt, Prof. dr.、University Children's hospital, Zürich
- 首席研究员:Daniel Konrad, Prof. dr.、University Children's hospital, Zürich
出版物和有用的链接
一般刊物
- Kazak AE, Brier M, Alderfer MA, Reilly A, Fooks Parker S, Rogerwick S, Ditaranto S, Barakat LP. Screening for psychosocial risk in pediatric cancer. Pediatr Blood Cancer. 2012 Nov;59(5):822-7. doi: 10.1002/pbc.24166. Epub 2012 Apr 10.
- Datye KA, Moore DJ, Russell WE, Jaser SS. A review of adolescent adherence in type 1 diabetes and the untapped potential of diabetes providers to improve outcomes. Curr Diab Rep. 2015 Aug;15(8):51. doi: 10.1007/s11892-015-0621-6.
- Delamater AM. Psychological care of children and adolescents with diabetes. Pediatr Diabetes. 2009 Sep;10 Suppl 12:175-84. doi: 10.1111/j.1399-5448.2009.00580.x. No abstract available.
- Litmanovitch E, Geva R, Rachmiel M. Short and long term neuro-behavioral alterations in type 1 diabetes mellitus pediatric population. World J Diabetes. 2015 Mar 15;6(2):259-70. doi: 10.4239/wjd.v6.i2.259.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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