The Telemedical Lifestyle Intervention Program TeLIPro (TeLIPro Health Program - Active With Diabetes)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,163
- 试验地点
- 2
- 主要终点
- HbA1c change
研究概览
简要总结
In a randomized-controlled trial the hypothesis should be tested that the Telemedical Lifestyle Intervention Program TeLIPro could significantly improve HbA1c (primary outcome), body weight and composition, cardiovascular risk factors, quality of life, eating behavior, and medication demand (secondary outcomes) in type 2 diabetes mellitus (T2DM) patients.
详细描述
T2DM patients, assured at the health insurance AOK Rhineland / Hamburg will be randomized into two parallel groups. In addition to routine care both groups will be provided a scale as well as a step counter and access to a secured online portal. The TeLIPro group will additionally got a glucose meter with test stripes fpr self-monitoring of blood glucose and telemedical coaching.
Participants of both groups will enter their anthropometric and metabolic data into a database on quarterly basis. In addition, the costs for diabetes-specific treatment, inpatient and outpatient treatment costs and drug costs will be analyzed on the basis of the routine data of the AOK Rhineland / Hamburg.
Patient preference for type 2 diabetes intervention will be recorded using Discrete Choice Experiment (DCE) questionnaires at the beginning of the program and at the end of the intervention. As part of the development and validation of the DCE, focus groups are used to determine the DCE attributes. In addition, focus groups should also be used during the data collection in order to obtain additional information on patient preferences by means of qualitative analysis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •body mass index of et least 27 kg/m2
排除标准
- •acute infections
- •chronic diseases other than type 2 diabetes and hypertension (e.g., cancer, chronic obstructive pulmonary disease, asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, macronephropathy/nephropathy, kidney insufficiency with glomerular filtration rate <30 ml/min/1.73 m2)
- •acute chemotherapy or chronic cortisol treatment
- •smoking cessation for <3 months and/or planned smoking cessation during study
- •pregnancy or breast-feeding
结局指标
主要结局
HbA1c change
时间窗: 12 months
estimated treatment difference between groups of HbA1c change (in T2DM patients with diabetes duration of ≥ 5 years)
remission rate
时间窗: 12 months
number of participants with an HBA1c \<6.5% (in T2DM patients with diabetes duration of \< 5 years)
次要结局
- diabetes-specific treatment costs(12 months)
- total cholesterol change(12 months)
- number of steps(12 months)
- weight change(12 months)
- diastolic blood pressure change(12 months)
- triglyceride change(12 months)
- antidiabetic medication change(12 months)
- inpatient costs(12 months)
- fasting blood glucose change(12 months)
- body mass index change(12 months)
- systolic blood pressure change(12 months)
- low-density lipoprotein (LDL) cholesterol change(12 months)
- outpatient costs(12 months)
- high-density lipoprotein (HDL) cholesterol change(12 months)
研究者
Stephan Martin
Director
West German Center of Diabetes and Health