| Popis: |
BackgroundThe use of digital technology to assess patients remotely can reduce clinical study costs. In the European Union, the 2D matrix code on prescription drug packaging serves as a unique identifier of a given package of medication, and thus, also of the patient receiving that medication. Scanning of the 2D matrix code may therefore allow remote patient authentication in clinical studies. ObjectiveThe aim of the DePRO study was to assess the feasibility of a fully digital data-capture workflow, the authentication of participants via drug packaging 2D matrix codes, in patients with type 2 diabetes mellitus (T2DM) who use metformin. The primary objective was to describe the self-care activities of these patients. Secondary objectives were to evaluate (1) the self-reported health status of these patients, (2) the association of self-care activities with demographics and disease characteristics, and (3) the usability of the my ePRO app. MethodsDePRO was an observational, multicenter, cross-sectional, digital, and patient-driven study conducted in Germany from June to December 2020. Adult patients prescribed metformin were invited to participate via their pharmacist or a medication tracker app. Participants downloaded the my ePRO app onto their own mobile device, scanned the 2D matrix code on their metformin package for registration and authentication, and provided informed consent via an electronic form. They were then able to complete a study-specific questionnaire on demographics and clinical characteristics, the German version of the Summary of Diabetes Self-Care Activities measure (SDSCA-G), the Diabetes Treatment Satisfaction Questionnaire (DTSQ), and the EQ-5D-5L. The patients conducted the study without support from a health care professional. Statistical analyses were exploratory and descriptive. ResultsIn total, 3219 patients were invited to participate. The proportion of patients giving consent was greater among those invited by pharmacists (19/217, 8.8%) than among those invited via the medication tracker app (13/3002, 0.4%). Of the 29 patients eligible for analysis, 28 (97%) completed all study questionnaires. Most of the patients (23/29, 79%) were aged |
