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临床试验/NCT01249742
NCT01249742已完成不适用

Sugarsquare. Focus on the Adolescent: Digital Treatment of Type 1 Diabetes Through the Internet

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Patients' Evaluation of Quality of Care

研究概览

简要总结

Background

The treatment of diabetes is multidisciplinary. Alignment of care of the various professional disciplines is, however, not always optimal. This can lead to confusion about treatment interventions and behavioral advices. In adolescence, good fine-tuned care is of extreme importance because of the difficulties in regulation of the disease in this phase of life (Snoek, 2004). These difficulties are due to biological changes but also to socio-psychological developmental changes. The adolescents' psychological development demands more autonomy and responsibility for the diabetes (care) by the adolescent. The social development can conflict with the treatment regime, because of the adolescents' social needs (ADA, 2001; Houdijk, 1998; Snoek, 2004). In this study the investigators assess whether an interactive website, on which adolescents with diabetes and their treatment team can communicate, leads to better alignment of care and better control over the disease.

Intervention

The diabetes has great impact on the adolescents' everyday life. Finding a balance between more autonomy, participating in social life with (healthy) peers and control of the disease is difficult and seems to act as a thread during this phase in life.

This can lead to questions and uncertainty at any given moment. The interactive website provides the adolescent access to information and to his or her individual treatment plan and advices fitted to his or her condition and life. The adolescent can pose questions at any given moment through the online forum and their personal treatment page. Since the treatment team answers the question within a day, fit between diabetes care and adolescents' everyday life is optimized.

Research question

Does an online interactive treatment environment, on which adolescents with diabetes can communicate with their treatment team, lead to better fit of care and to better disease control?

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
12 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • adolescents aged 12 and older;
  • diagnosed with diabetes mellitus;
  • receiving regular outpatient hospital-delivered diabetes care provided by the Children's Diabetes Center Nijmegen (CDCN)

排除标准

  • adolescents who were unable to read questionnaires because of language, or cognitive problems were excluded

结局指标

主要结局

Patients' Evaluation of Quality of Care

时间窗: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).

Participants' appreciation of our diabetes care was assessed using the Patients' Evaluation of Quality of Diabetes care (PEQ-D; Pouwer \& Snoek, 2002). This questionnaire consists of 14 items, such as: 'The amount of information I receive from the doctor is…'. The adolescent is asked to answer by means of a 5-point lykert scale varying from 1) bad to 5) excellent.

次要结局

  • Health Related Quality of Life(T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).)
  • Glycemic control (HbA1c)(T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).)
  • Degree of use of intervention(T1 (6 months following start of intervention))
  • Adolescents' disease knowledge(T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).)
  • Confidence In Diabetes Selfcare(T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).)

研究者

申办方类型
Other

研究点 (2)

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