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临床试验/NCT00326573
NCT00326573终止1 期

A Multicentre, Randomised Controlled Trial of Motivational Interviewing in Adolescents With Diabetes

Cardiff University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2001年10月1日最近更新:
适应症

试验速览

阶段
1 期
状态
终止
入组人数
80
试验地点
2
主要终点
HbA1C at 6 months, end of intervention and one year follow up

研究概览

简要总结

The management of diabetes in adolescence presents significant difficulties due to psychological and physiological factors. Blood glucose control deteriorates in this age group and poor management threatens long-term health. Motivational Interviewing, a psychological intervention designed to facilitate behaviour change, has recently been used with a small group of teenagers, producing improved blood glucose control. To establish the impact of this intervention and its key components, we plan to compare the outcome in several clinics over a longer period of time in a larger number of adolescents selected at random to undergo motivational interviewing or to act as a control group. If successful this approach has potential to be incorporated into the routine clinical care of adolescents with diabetes.

详细描述

Diabetes in adolescence is associated with deterioration in glycaemic control and self-care, resulting in increased risk of long-term complications. Although psychosocial factors are recognized as playing an important part in these changes and therefore in clinical management, there are few indicators from research studies of practical, effective interventions. Motivational interviewing is a counselling approach designed to facilitate decision-making about behaviour change. It has been shown to be effective in a variety of clinical settings, including diabetes care in an adult population. In a BDA-funded pilot study of motivational interviewing with adolescents, our group has shown that the intervention improves glycaemic control (glycosylated haemoglobin), at least in the short-term. This study aims to replicate and extend the findings of the pilot study in a multicentre, randomised, controlled trial over a longer intervention period with a larger sample. The intervention will be monitored to facilitate analysis and description of key components. Other psychological variables thought to be of significance in the self-care of adolescents with diabetes will be measured. If the results indicate that this is a successful intervention, the method has potential to be disseminated and applied within routine clinical practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Educational Counseling Training
盲法
None

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 14-17
  • With type 1 diabetes
  • Attending diabetes clinic in participating centre

排除标准

  • Less than one year since diagnosis
  • Learning disabilities
  • Other medical conditions affecting diabetes management
  • Accommodated by social services

结局指标

主要结局

HbA1C at 6 months, end of intervention and one year follow up

次要结局

  • well being at baseline and end of one year intervention
  • family behaviour at baseline and end of one year intervention
  • quality of life at baseline and end of one year intervention

研究者

申办方类型
Other

研究点 (2)

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