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临床试验/NCT00391040
NCT00391040已完成不适用

SGS: a Structured Treatment and Teaching Programme for Elderly Patients With Diabetes Mellitus - a Prospective Randomized Controlled Multicenter Trial

German Diabetes Association1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2003年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
HbA1c decrease, reduction of hypoglycemia, acute complications

研究概览

简要总结

It was the aim of the study to develop and evaluate the effectiveness of a new structured teaching and training programme for elderly patients with diabetes mellitus (SGS) and insulin therapy.

详细描述

Patient education has become an integral part of any diabetes therapy in Germany. But elderly people are often not able to follow the variety of topics comprising standard treatment and training programmes for insulin-treated patients with type 2 diabetes mellitus due to geriatric syndromes and neuropsychological deficits. Therefore, treatment of elderly diabetics should focus on individual therapeutic goals, which reflect reduced life expectancy and quality of life.

It was the aim of the study to develop and evaluate the effectiveness of a new structured teaching and training programme for elderly patients with diabetes mellitus (SGS) and insulin therapy.

The high prevalence of cognitive impairment and affective disorders requires special pedagogical methods as well as adapted contents. For example the advantages of physical activity, the frequent existence of malnutrition, urinary incontinency or heart failure are taken into consideration. Contents are transmitted in a practical and daily-living oriented way.

The programme comprises 7 education lessons of 45 minutes duration implying the education units: diabetes mellitus, nutrition, treatment strategies, self-monitoring and complications focussing the diabetic foot syndrome.

The effectiveness of the new structured treatment and teaching programme SGS was evaluated in a multicenter prospective randomised controlled trial. Diabetic patients admitting one of 18 study centres in Germany with at least one geriatric syndrome, comorbidity and older than 65 years were randomised either to the new SGS programme or to the standard treatment programme for patients with type 2 diabetes mellitus. Before and 6 month after participation in the structured treatment programmes the outcome quality was evaluated using structured questionnaires. We assessed HbA1c, skills of diabetes self-management, diabetes knowledge, treatment satisfaction, acute and late complications, neuropsychological status, diabetes mediation, activities of daily living and need of social service. The main treatment goal was maintenance of autonomy and quality of life in elderly people, as well as prevention of catabolism, frailty and acute complications.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age older than 65 years, at least more than one other diagnosis than diabetes, at least one geriatric syndrome

排除标准

  • •myocardial infarction, apoplexy within the last 2 weeks before planned enrolment

结局指标

主要结局

HbA1c decrease, reduction of hypoglycemia, acute complications

次要结局

  • treatment satisfaction, ability for diabetes management, diabetes knowledge

研究者

发起方
German Diabetes Association
申办方类型
Other

研究点 (1)

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