Study to Learn More About Outcomes Reported by Patients Suffering From Type 2 Diabetes Using a Digital Data Collection Tool (DePRO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04383041|
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : September 4, 2020
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Other: No intervention|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Digital Collected Patient Reported Outcomes in a Diabetes Cohort|
|Actual Study Start Date :||June 28, 2020|
|Estimated Primary Completion Date :||September 15, 2020|
|Estimated Study Completion Date :||December 15, 2020|
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
- Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) Score [ Time Frame: 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.
- Association between SDSCA score and demographic/ disease characteristics [ Time Frame: Baseline ]Association of Summary of Diabetes Self-Care Activities for Diabetes and Kidney Disease (SDSCA) with demographic and disease characteristics
- Acceptance of participation [ Time Frame: Baseline ]
- Adherence to documentation [ Time Frame: Baseline ]
- Health related Quality of Life-EuroQol five dimensions Questionnaire (EQ-5D) [ Time Frame: 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 [ Time Frame: Baseline ]Diabetes Treatment Satisfaction Questionnaire (DTSQ) Number of invited, participating and non-participating patients (reasons for non-acceptance of study participation)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04383041
|Contact: Bayer Clinical Trials Contact||(+)1-888-84 email@example.com|
|Multiple Locations, Germany|
|Study Director:||Bayer Study Director||Bayer|