DePRO: Study to Learn More About Outcomes Reported by Patients Suffering From Type 2 Diabetes Using a Digital Data Collection Tool
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with Type 2 Diabetes Patients with Metformin containing prescription drugs will be eligible for participation and consecutively invited to study participation in their pharmacy. |
Other: No intervention
Completing questionnaires via ePRO app from their own mobile devices
|
Outcome Measures
Primary Outcome Measures
- Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) Score [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.
Secondary Outcome Measures
- Association between SDSCA score and demographic/ disease characteristics [Baseline]
Association of Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) with demographic and disease characteristics
- Acceptance of participation [Baseline]
- Adherence to documentation [Baseline]
- Health related Quality of Life-EuroQol five dimensions Questionnaire (EQ-5D) [Baseline]
Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
- DTSQ Participation rate [Baseline]
Diabetes Treatment Satisfaction Questionnaire (DTSQ) Number of invited, participating and non-participating patients (reasons for non-acceptance of study participation)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
- Not applicable
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many locations | Multiple Locations | Germany |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21318