DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 74
- 主要终点
- HbA1c
研究概览
简要总结
Patients with type-2 diabetes mellitus have an higher risk developing secondary disorders. In an epidemiological longitudinal study of about 1.150 patients with type 2 diabetes mellitus we investigate determinants and predictors for long-term prognosis. The patients are recruited and supervised in practices of general practitioners of the administrative district of Ludwigsburg/Heilbronn (Baden-Württemberg, Germany). In a subgroup of about 200 patients with a dissatisfactory metabolic status (HbA1c > 7,5%) a randomised interventional study is performed. The intervention comprises a telephone counseling by the medical secretary of each practice executed in a predefined period of time. The outcome parameters of interest are the change of HbA1c, the development of secondary disorders and adverse events, quality of life and risk factor control, as well as hospitalization and mortality.
The aim of the study was to develop an patient-centred instrument implementable in the routine medical care in order to enhance the prognosis of patients with type-2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with type-2 diabetes mellitus attending the general practitioner's in the time from October to December 2008
- •Ability to take part in the study
排除标准
- •Nursing home resident
- •Insufficient knowledge of the German language
- •Palliative health care with limited life expectancy
- •Emergency outpatient
- •All outpatients who attend the general practitioner by way of exception
研究组 & 干预措施
Control group
No telephone counseling + usual care
Telephone Counseling
Telephone counseling + usual care
干预措施: Telephone counseling (Other)
结局指标
主要结局
HbA1c
时间窗: 18 months
次要结局
- health-related quality of life(18 months)
- lipid metabolism control(18 months)
- risk factor control (eg. body weight, physical activity, smoking)(18 months)
- hospitalization(18 month)
- CHD, mortality(18 months)
- incidence of diabetes-related complications(18 months)