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临床试验/NCT02361606
NCT02361606已完成不适用

An Internet Cognitive-Behavioral Intervention for Youth With Type 1 Diabetes - Participation and Efficacy

Dr. Orit Hamiel0 个研究点目标入组 89 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
主要终点
Change in quality of life. (Diabetes Quality of Life (DQOL) questionnaire)

研究概览

简要总结

Adolescents are often reluctant to receive psychological help. The investigators developed a web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes. The investigators aimed to examine the participation rate and outcomes on glycemic control and quality of life.

详细描述

Adolescents are often reluctant to receive psychological help. The investigators developed a web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes. The investigators aimed to examine the participation rate and outcomes on glycemic control and quality of life.

Single center study was conducted to describe participation and efficacy of internet cognitive-behavioral intervention for youth with type 1 diabetes. Adolescents with type 1 diabetes, aged 13-20 years, treated at a Juvenile Diabetes Center, were offered to participate in the intervention. Recruitment period lasted for 2 months, during January-February, 2011.

HbA1c measures of adolescents that agreed to participate, were obtained from medical records.The adolescents, that logged in, were asked to complete questionnaires before the intervention assessing their expectations of the program, quality of life and parental support. After completion of questionnaires, the adolescents were encouraged to complete 6 virtual sessions. Satisfaction was assessed after each session. In the end of the program, participants were asked again to complete questionnaires. HbA1c levels were obtained again for participants that logged in, and for participants that passively refused, 3 months or more after the recruitment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
13 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis with diabetes for at least 1 year
  • treated at Juvenile Diabetes Center
  • fluent Hebrew speakers

排除标准

  • no previous diagnosis of a psychiatric condition (such as an eating disorder)
  • no opposition to the internet due to religious issues.

结局指标

主要结局

Change in quality of life. (Diabetes Quality of Life (DQOL) questionnaire)

时间窗: Change from baseline to the end of intervention (3 to 6 months from baseline)

Filled in the intervention website.

Perceived parent support. (Short version of the Social Provision Scale)

时间窗: Change from baseline to the end of intervention (3 to 6 monts)

Short version of the Social Provision Scale -filled in the intervention website.

Youth satisfaction of the program. (Questionnaire regarding the degree that the session was helpful.)

时间窗: Measured at the end of every virtual session (2 days to 6 months from baseline).

Questionnaire regarding the degree that the session was helpful.

次要结局

  • Change in glycemic control. (HbaA1c levels, obtained from medical records)(Last HbA1C before recruitment period and first HbA1C after recruitment period were obtained from medical records (3-12 months from baseline).)

研究者

发起方
Dr. Orit Hamiel
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Dr. Orit Hamiel

Specialist in Pediatric Endocrinology, Pediatric Endocrinology and Juvenile Deibetes Head Department, Sheba Medical Center; Head of Juvenile Diabetes Center, Maccabi Health Services

Sheba Medical Center

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