The Copenhagen Rehabilitation Trial Part 2: Telemedicine as a Means to Achieve Good Diabetes Control Among Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Changes in HbA1c
研究概览
简要总结
The aim of the study is to investigate the effect of telemedicine among the group of type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the patients with regards to vulnerability and social resources and to determine wich groups benefit the most from telemedicine.
详细描述
Type-2-diabetes is a growing healthcare problem. Both because of the increasing amount of patients and because of the complications of diabetes.
Non-pharmacological treatment is considered fundamental in the treatment of patients with type-2-diabetes.
In the Community of Copenhagen, all patients diagnosed with diabetes receive rehabilitation. The rehabilitation consists of counseling with regards to nutrition, physical activity, smoking cessation and education about diabetes.
Some patients however, remain poorly regulated despite rehabilitation as well as pharmacological treatment.
A total number of 165 patients will be randomized to intervention group or standard care.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HbA1c > 7,5%
- •BMI > 25
- •Spoken danish
- •Completed a rehabilitation program more than 6 months ago
排除标准
- •HbA1c < 7,5%
- •BMI < 25
- •Need of interpreter
研究组 & 干预措施
Telemedicine
Monthly video consultations with a nurse as add-on to standard treatment.
干预措施: Telemedicine (Behavioral)
Standard treatment
Standard diabetes control at a Diabetes Clinic or GP
结局指标
主要结局
Changes in HbA1c
时间窗: Baseline, 16 weeks, 32 weeks, 6 months after intervention
次要结局
- Use of medication(Baseline, 32 weeks)
- Body mass index(Baseline, 32 weeks)
- Beta-cell function test (HOMA)(Baseline, 32 weeks)
- Weight(Baseline, 32 weeks)
- Bloodpressure(Baseline, 32 weeks)
- Fasting total cholesterol, LDL, HDL, triglycerides(Baseline, 32 weeks)
- Physical activity(Baseline, 32 weeks)
- Hip circumference(Baseline, 32 weeks)
- Change in quality of life(Baseline, 32 weeks)
- Waist circumference(Baseline, 32 weeks)
研究者
Caroline Raun Hansen
MD
Bispebjerg Hospital