Regions of Europe Working Together for Health (Renewing Health)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 6
- 主要终点
- Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
研究概览
简要总结
Evaluation whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with type 2 diabetes mellitus. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2DM diagnosed > 3 months prior to the enrollment
- •HbA1c >= 6,5 %
- •Capability of filling questionnaires by their own language
- •Being able to use the devices provided
- •Being cognitively able to participate
排除标准
- 未提供
结局指标
主要结局
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
时间窗: 12 months
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Mearurement at the beginning and after 12 months, Scales from 0 to 100, higher values represent a better outcome; Data are mean scores (SD); differences between groups after 12 month were compared by using Mann-Whitney-U-tests.
HbA1c
时间窗: 12 months
HbA1c was taken at the beginning of the study and after 12 months.
次要结局
- Blood Pressure(12 months)
- Blood Lipids(12 months)
- Body Weight(12 months)
- Medication Changes(12 months)
- Presence of Diabetic Complications(12 months)
- Number of Hospitalisations(12 months)