Prospective Randomized Trial for the Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 主要终点
- Changes in Glycemic Control Measured by A1c
研究概览
简要总结
This study is a randomized prospective trial with 6-month follow up. A non-inferiority hypothesis is tested. A new developed treatment and education programme for type 1 diabetic patients (PRIMAS) will be tested compared to an established treatment and education programme (German DTTP). Primary outcome variable is glycemic control at 6-month follow up. Secondary outcome variables are: diabetes knowledge, diabetes related distress, depressive symptoms, diabetes self-efficacy, self-care behavior, attitudes towards diabetes and insulin treatment, hypoglycemia awareness.
详细描述
Both programmes consists of 12 lessons with a length of 90 minutes. Eligible type 1 diabetic patients in a diabetologist practice are pooled and randomised either to the new developed PRIMAS programme or to an established education programme for type 1 diabetic patients (DTTP - Treatment and education programme for intensified insulin treatment) as an active comparator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes, diabetes duration > 4 weeks, age 18 - 75 years, BMI 20 - 40 kg/m², A1c 7 - 13 %, ability to understand, speak and write German language, written informed consent.
排除标准
- •current treatment of psychological or psychiatric disorder, dementia or severe cognitive impairment, severe organic disease (e.g. terminal renal disease, cancer with poor prognosis), preventing a regular participation in the training course, pregnancy.
研究组 & 干预措施
PRIMAS group
PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
干预措施: PRIMAS (Behavioral)
Control group
The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
干预措施: DTTP (Behavioral)
结局指标
主要结局
Changes in Glycemic Control Measured by A1c
时间窗: Baseline and 6 months
Difference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority.
次要结局
- Diabetes Knowledge(6 month)
- Summary of Diabetes Self-Care Activities (SDSCA)(6 month)
- CES-D Score(6 month follow up)
- Diabetes Self-Efficacy Scale(6 Month Follow up)
- Treatment Satisfaction / Problem Areas in Dealing With Diabetes(6 Month Follow up)
- Hypoglycaemia Awareness Score(6 month)
- Diabetes Distress Scale (DDS)(6 month follow up)
- Diabetes Empowerment Score (DES)(6 month follow up)
- Evaluation of the Diabetes Education Course(6 month Follow up)
研究者
Norbert Hermanns
PhD
Forschungsinstitut der Diabetes Akademie Mergentheim