Digital Collected Patient Reported Outcomes in a Diabetes Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) Score
研究概览
简要总结
In this study researchers want to gain more information on patients who are treated with Metformin for their Type 2 Diabetes. Adult female and male patients with a prescription of a Metformin containing drug will be invited to the study in a public pharmacy after the decision for treatment with Metformin has been made by the treating physician. The pharmacist will provide interested participants access to a special phone App and participants are asked to complete via this phone App a questionnaire on their health situation with special focus on their Type 2 Diabetes. This includes questions on complications and self-care activities in relation to their diabetes, questions on quality of life and health history. There will be no extra visit to the treating doctor or a pharmacy. The study is aiming to have the questionnaire completed by 300 participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Adult female or male patient
- •Valid prescription for a Metformin containing drug approved in Germany
- •Decision to initiate treatment with Metformin was made by the treating physician as part of the routine treatment practice
- •Signed informed consent
排除标准
- •Not applicable
结局指标
主要结局
Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) Score
时间窗: Baseline
The SDSCA measure is a brief self-report questionnaire of diabetes self-management. It assesses the number of days per week in which respondents engage in diabetes health-related behaviors in the areas of general diet, diabetes-specific diet, physical activity, blood-glucose testing, foot care, and smoking. Minimum score 0. Maximum score 77. Higher scores indicate better self care.
次要结局
- Association between SDSCA score and demographic/ disease characteristics(Baseline)
- DTSQ Participation rate(Baseline)
- Acceptance of participation(Baseline)
- Adherence to documentation(Baseline)
- Health related Quality of Life-EuroQol five dimensions Questionnaire (EQ-5D)(Baseline)