Diabetes Mellitus, Type 2 Clinical Trial
— DePROOfficial title:
Digital Collected Patient Reported Outcomes in a Diabetes Cohort
NCT number | NCT04383041 |
Other study ID # | 21318 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2, 2020 |
Est. completion date | January 27, 2021 |
Verified date | June 2021 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | January 27, 2021 |
Est. primary completion date | December 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Many locations | Multiple Locations |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) Score | 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. | Baseline | |
Secondary | Association between SDSCA score and demographic/ disease characteristics | Association of Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) with demographic and disease characteristics | Baseline | |
Secondary | Acceptance of participation | Baseline | ||
Secondary | Adherence to documentation | Baseline | ||
Secondary | Health related Quality of Life-EuroQol five dimensions Questionnaire (EQ-5D) | Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). | Baseline | |
Secondary | DTSQ Participation rate | Diabetes Treatment Satisfaction Questionnaire (DTSQ) Number of invited, participating and non-participating patients (reasons for non-acceptance of study participation) | Baseline |
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