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临床试验/NCT01317459
NCT01317459Unknown不适用

Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
216
试验地点
2
主要终点
Change in HbA1c

研究概览

简要总结

Background: 50% of people with diabetes are living with too high blood sugars and increased risk of diabetes related complications together with poor quality of life. The need to improve diabetes care by better enabling patients to utilise their individual and local resources to self-manage the condition is widely recognized, yet there is a lack of access to evidence-based patient-centred healthcare interventions. At present the individual patient's judgement of own concrete situation mostly remains unexplored and insufficiently used in decision-making causing that problems perceived by the patient in living with the illness remain unrecognised and insufficiently resolved.

Aim and Methods: Guided self-determination (GSD) is an educational method developed to promote patient autonomy, participation, skills building and intrinsic motivation. In this evidence-based group-intervention the main objective is to implement and evaluate GSD through a randomised controlled trial. GSD methods will be performed seven times for the intervention group. The control group will receive traditional out-patient consultations - 'care as usual' Outcome measures will be performed at baseline, after 9 and 18 months. The project will focus on adults with type 1 diabetes (18-55 yrs) where an improvement will be highly cost-effective in preventing late complications and enhanced psychosocial health. GSD is presumably an intervention providing psychosocial support applicable in busy clinical practice.

An alliance is established between Haukeland University Hospital, Norway and Steno Diabetes centre, Copenhagen, Denmark, Centre of Evidence-Based Practice, Bergen University College, and Bergen University to conduct this intervention and thus make the best possible use of interrelated knowledge within the issue.

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
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetes type one, HbA1c >= 8%

排除标准

  • Pregnancy, decreased cognitive function and/or serious mental health disturbances, language barriers to the Norwegian language

结局指标

主要结局

Change in HbA1c

时间窗: 0, 9 and 18 months

次要结局

  • PCD scales(0, 9 and 18 months)
  • DDS scales(0, 9 and 18 months)
  • TSRQ scales(0, 9 and 18 months)
  • PAID scales(0, 9 and 18 months)
  • Who 5(0, 9 and 18 months)
  • Rosenberg's self-esteem scale(0, 9 and 18 months)
  • HCCQ scales(0, 9 and 18 months)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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