Trial Condition(s):
Diabetes Mellitus, Type 2
Study to learn more about outcomes reported by patients suffering from type 2 diabetes using a digital data collection tool (DePRO)
Bayer Identifier:
21318
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Many locations, Germany | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Digital collected Patient Reported Outcomes in a Diabetes Cohort
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) ScoreThe 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.Timeframe: Baseline
Secondary Outcome
- Association between SDSCA score and demographic/ disease characteristicsAssociation of Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) with demographic and disease characteristicsTimeframe: Baseline
- Acceptance of participationTimeframe: Baseline
- Adherence to documentationTimeframe: Baseline
- 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).Timeframe: Baseline
- DTSQ Participation rateDiabetes Treatment Satisfaction Questionnaire (DTSQ) Number of invited, participating and non-participating patients (reasons for non-acceptance of study participation)Timeframe: Baseline
Additional Information
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