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OpenTrials
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NCT Number: NCT04383041

Study to Learn More About Outcomes Reported by Patients Suffering From Type 2 Diabetes Using a Digital Data Collection Tool

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Completing questionnaires via ePRO app from their own mobile devices

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Acceptance of participation

    Time frame: Baseline

  3. Adherence to documentation

    Time frame: Baseline

  4. 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).

  5. 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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Digital Collected Patient Reported Outcomes in a Diabetes Cohort

Acronym: DePRO

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 11, 2020
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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