Evaluation of Self-Care Activities and Quality of Life in Patients With Type 2 Diabetes Mellitus Treated With Metformin Using the 2D Matrix Code of Outer Drug Packages as Patient Identifier: Protocol for the DePRO Proof-of-Concept Observational Study

Mueller, Christian; Schauerte, Isabel; Martin, Stéphan

doi:10.2196/21727

Cited by 7 publications

(7 citation statements)

References 18 publications

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“…As a future use, results derived by this study may also serve as socioeconomically and medically stratified population references for individual monitoring of HRQoL. Approaches using the EQ-5D instrument are under development for patient groups in oncology, asthma and diabetes [38][39][40]. With monitoring extending to other patient and population groups, population reference values are set to increase in relevance.…”

Section: Discussionmentioning

confidence: 99%

Inequality and heterogeneity in health-related quality of life: findings based on a large sample of cross-sectional EQ-5D-5L data from the Swedish general population

et al. 2021

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Purpose This study aimed to investigate inequality and heterogeneity in health-related quality of life (HRQoL) and to provide EQ-5D-5L population reference data for Sweden. Methods Based on a large Swedish population-based survey, 25,867 respondents aged 30‒104 years, HRQoL is described by sex, age, education, income, economic activity, health-related behaviours, self-reported diseases and conditions. Results are presented by EQ-5D-5L dimensions, respondents rating of their overall health on the EQ visual analogue scale (EQ VAS), VAS index value and TTO (time trade-off) index value allowing for calculation of quality-adjusted life years (QALYs). Ordinary Least Squares and multivariable logistic regression analyses were used to study inequalities in observed EQ VAS score between socioeconomic groups and the likelihood to report problems on the dimensions, respectively, adjusted for confounders. Results In total, 896 different health states were reported; 24.1% did not report any problems. Most problems were reported with pain/discomfort. Women reported worse HRQoL than men, and health deteriorated with age. The strongest association between diseases and conditions and EQ VAS score was seen for depression and mental health problems. There was a socioeconomic gradient in HRQoL; adjusting for health-related behaviours, diseases and conditions slightly reduced the differences between educational groups and income groups, but socioeconomic inequalities largely remained. Conclusion EQ-5D-5L population reference (norms) data are now available for Sweden, including socioeconomic differentials. Results may be used for comparisons with disease-specific populations and in health economic evaluations. The observed socioeconomic inequality in HRQoL should be of great importance for policy makers concerned with equity aspects.

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Section: Discussionmentioning

confidence: 99%

Inequality and heterogeneity in health-related quality of life: findings based on a large sample of cross-sectional EQ-5D-5L data from the Swedish general population

et al. 2021

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“…IDS and Bayer have codeveloped a data capture tool, the my ePRO app, which can be used for stand-alone studies or in association with randomized controlled trials and observational studies. The usability of the my ePRO app was assessed in the DePRO study [ 26 ]. The DePRO study showed that digitally authenticating eligible patients, with participants registering by scanning the 2D matrix code on the outer packaging of their prescribed medication (a standard feature of prescription medications in the European Union) is a feasible approach for a digital study (manuscript in preparation).…”

Section: Discussionmentioning

confidence: 99%

Ascertaining Medication Use and Patient-Reported Outcomes via an App and Exploring Gamification in Patients With Multiple Sclerosis Treated With Interferon β-1b: Observational Study

Limmroth¹,

Bayer-Gersmann²,

Mueller³

et al. 2022

JMIR Form Res

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Background The BETACONNECT autoinjector and myBETAapp app were designed to support patients with multiple sclerosis receiving interferon β-1b and are an ideal platform for digital observational studies. A recent pilot study in Germany demonstrated the feasibility of using the app to recruit patients, obtain informed consent, and evaluate medication-taking behavior over 6 months. Objective This study aims to describe medication-taking behavior for 1 year in patients with multiple sclerosis receiving interferon β-1b based on data collected from the app and to provide information on patient-reported outcomes (PROs). The optional use of the cognitive training tool PEAK (Peak, formerly Brainbow Ltd) is included to test the feasibility of gamification in this setting. Methods A prospective and retrospective, exploratory, digital, observational cohort study was conducted among users of the app in Germany. Invitations to participate were sent to patients’ apps between February and May 2019. Participants provided electronic informed consent. Injection-related data from consenting patients’ devices were collected prospectively for 1 year following the consent date and retrospectively for ≤1 year from the first day of use (if historical data were available). Participants also completed three electronic PRO instruments every 3 months: the EuroQol 5-Dimension, 5-Level questionnaire (EQ-5D-5L); the Treatment Satisfaction Questionnaire for Medication (TSQM; version II); and a questionnaire on satisfaction with treatment support (on a server accessed via an emailed hyperlink). All patients were offered optional access to the professional version of PEAK. Results Of 1778 registered app accounts (May 2019), 79 patients (4.44%) provided informed consent; 62 (3.49%) were eligible for inclusion in the prospective analysis, of whom, 60 (97%) also had retrospective data. The mean age of the 62 participants was 43.2 (SD 11.5) years and 41 (66%) were women. Compliance over the 1-year prospective observational period (primary end point) was high (median 98.9%, IQR 94.3%-100%) and similar among men and women. Persistence and adherence (coprimary end points) decreased from 85% (53/62) and 74% (46/62), respectively, at 6 months to 76% (47/62) and 65% (40/62), respectively, at 12 months; both were higher in men than in women. A retrospective analysis showed similar patterns. The PRO questionnaires were answered by 79% (49/62) of the participants at baseline and 50% (31/62) of them at month 12. Women had more severe problems in some EQ-5D-5L dimensions (mobility, usual activities, and pain/discomfort) and lower median convenience scores on the TSQM (version II) than men. At month 12, 84% (26/31) of the patients were satisfied or very satisfied with the app. PEAK was used by 67% (14/21) of men and 49% (20/41) of women. Conclusions This study showed high compliance and decreasing persistence and adherence over 1 year and demonstrated the feasibility of including remotely completed electronic PRO instruments in digital observational studies.

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“…The limitations of the DePRO study design have been described in detail previously [ 6 ]. Briefly, they include its reliance on PROs, the identification of patients via a 2D matrix code on drug packaging rather than a validated diagnosis by a health care professional, possible selection bias toward patients who are young technophiles, the lack of verification of medication intake, the single-arm design, the focus on users of metformin rather than all patients with T2DM, geographic bias toward western Germany, and anonymized data (making source-data verification impossible).…”

Section: Discussionmentioning

confidence: 99%

“…Eligible patients were invited via their pharmacist (who personally handed out a download link for the my ePRO app on a postcard alongside the patient’s metformin-containing medication and explained the study workflow to the patients—downloading the my ePRO app, scanning the 2D matrix code, consenting, answering the questionnaires, and then getting reimbursed) or via the MyTherapy medication tracker app (SmartPatient). The latter route was added as a revision to the original published study design [ 6 ] following difficulties recruiting sufficient pharmacies because of restrictions related to the COVID-19 pandemic (we originally planned to recruit 12 diabetes-focused pharmacies, but of the 35 pharmacies contacted, only 4 participated in the study). All patients who were registered on the medication tracker app and were taking metformin-containing medications in Germany were invited twice (on December 2 and 7, 2020) via an in-app message to participate in the DePRO study.…”

Section: Methodsmentioning

confidence: 99%

“…We designed the DePRO study to assess the feasibility of a fully digital data-capture workflow with the authentication of eligible patients via the 2D matrix codes on drug packaging [ 6 ]. The target population was patients with type 2 diabetes mellitus (T2DM) who had been prescribed metformin (the recommended initial treatment for T2DM [ 7 ]).…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of Self-care Activities and Quality of Life in Patients With Type 2 Diabetes Treated With Metformin Using the 2D Matrix Code of Outer Drug Packages as Patient Identifier: the DePRO Proof-of-Concept Observational Study

Mueller¹,

Schauerte²,

Martin³

et al. 2022

JMIR Diabetes

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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. Trial Registration ClinicalTrials.gov NCT04383041; https://clinicaltrials.gov/ct2/show/NCT04383041 International Registered Report Identifier (IRRID) RR2-10.2196/21727

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Evaluation of Self-Care Activities and Quality of Life in Patients With Type 2 Diabetes Mellitus Treated With Metformin Using the 2D Matrix Code of Outer Drug Packages as Patient Identifier: Protocol for the DePRO Proof-of-Concept Observational Study

Cited by 7 publications

References 18 publications

Inequality and heterogeneity in health-related quality of life: findings based on a large sample of cross-sectional EQ-5D-5L data from the Swedish general population

Inequality and heterogeneity in health-related quality of life: findings based on a large sample of cross-sectional EQ-5D-5L data from the Swedish general population

Ascertaining Medication Use and Patient-Reported Outcomes via an App and Exploring Gamification in Patients With Multiple Sclerosis Treated With Interferon β-1b: Observational Study

Evaluation of Self-care Activities and Quality of Life in Patients With Type 2 Diabetes Treated With Metformin Using the 2D Matrix Code of Outer Drug Packages as Patient Identifier: the DePRO Proof-of-Concept Observational Study

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