背景:使用数字技术远程评估患者可以降低临床研究成本。在欧盟,处方药包装上的2D矩阵代码用作给定药物包装的唯一标识符,因此,也是接受药物治疗的患者。因此,2D矩阵码的扫描可允许临床研究中的远程患者认证。
目的:DePRO研究的目的是评估全数字化数据采集工作流程的可行性。通过药物包装2D矩阵码认证参与者,在使用二甲双胍的2型糖尿病(T2DM)患者中。主要目的是描述这些患者的自我护理活动。次要目标是评估(1)这些患者的自我报告健康状况,(2)自我护理活动与人口统计学和疾病特征的关联,和(3)我的EPRO应用程序的可用性。
方法:DePRO是一种观察性的,多中心,横截面,数字,以及2020年6月至12月在德国进行的患者驱动研究。服用二甲双胍的成年患者被邀请通过其药剂师或药物追踪器应用程序参与。参与者将我的ePRO应用程序下载到他们自己的移动设备上,扫描他们的二甲双胍包装上的2D矩阵代码进行注册和认证,并通过电子形式提供知情同意书。然后,他们能够完成关于人口统计学和临床特征的研究特定问卷,德文版糖尿病自我护理活动措施摘要(SDSCA-G),糖尿病治疗满意度问卷(DTSQ),还有EQ-5D-5L.患者在没有医疗保健专业人员支持的情况下进行了研究。统计分析是探索性和描述性的。
结果:总计,3219名患者被邀请参加。药剂师邀请的患者中同意的比例(19/217,8.8%)高于通过药物跟踪器应用程序邀请的患者(13/3002,0.4%)。在符合分析条件的29名患者中,28人(97%)完成了所有研究问卷。大多数患者(23/29,79%)年龄<60岁,59%(17/29)为男性。患者在7天中平均总共花费3.5天(SD1.3)进行自我护理活动(SDSCA-G)。大多数患者(24/29,83%)对他们目前的治疗(DTSQ)感到非常满意。29名患者中有20名(69%)报告了感知到的高血糖或低血糖事件。28名患者中有18名(64%)报告了最佳的健康状况(EQ-5D-5L)。年龄与一般饮食和特定饮食的时间呈正相关(斯皮尔曼系数分别为0.390和0.434)。
结论:DePRO研究证明了在T2DM患者中进行全数字认证(通过药物包装上的2D矩阵代码)和数据采集的可行性。个人邀请比通过药物跟踪器应用程序进行的远程邀请产生更高的招聘率。实现了较高的问卷完成率,根据29名患者中的28名完成。
背景:ClinicalTrials.govNCT04383041;https://clinicaltrials.gov/ct2/show/NCT04383041。
未经评估:RR2-10.2196/21727。
BACKGROUND: The 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.
OBJECTIVE: The 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.
METHODS: DePRO 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.
RESULTS: In 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 <60 years, and 59% (17/29) were male. The patients spent a mean total of 3.5 (SD 1.3) days out of 7 days on self-care activities (SDSCA-G). Most patients (24/29, 83%) were satisfied to extremely satisfied with their current treatment (DTSQ). Events of perceived hyperglycemia or hypoglycemia were reported by 20 of 29 (69%) patients. The best possible health status (EQ-5D-5L) was reported by 18 of 28 (64%) patients. Age was positively correlated with time spent on general and specific diet (Spearman coefficient 0.390 and 0.434, respectively).
CONCLUSIONS: The DePRO study demonstrates the feasibility of fully digital authentication (via 2D matrix codes on drug packaging) and data capture in patients with T2DM. Personal invitations yielded higher recruitment rates than remote invitations via the medication tracker app. A high questionnaire completion rate was realized, based on completion by 28 out of 29 patients.
BACKGROUND: ClinicalTrials.gov NCT04383041; https://clinicaltrials.gov/ct2/show/NCT04383041.
UNASSIGNED: RR2-10.2196/21727.