A randomized wait-list control trial to evaluate the impact of a mobile application to improve self-management of individuals with type 2 diabetes: a study protocol

Abstract

BackgroundManagement of diabetes through improved glycemic control and risk factor modification can help prevent long-term complications. Much diabetes management is self-management, in which healthcare providers play a supporting role. Well-designed e-Health solutions targeting behavior change can improve a range of measures, including glycemic control, perceived health, and a reduction in hospitalizations.MethodsThe primary objective of this study is to evaluate if a mobile application designed to improve self-management among patients with type 2 diabetes (T2DM) improves glycemic control compared to usual care. The secondary objectives are to determine the effects on patient experience and health system costs; evaluate how and why the intervention worked as observed; and gain insight into considerations for system-wide scale-up. This pragmatic, randomized, wait-list-control trial will recruit adult participants from three Diabetes Education Programs in Ontario, Canada. The primary outcome is glycemic control (measured by HbA1c). Secondary outcomes include patient-reported outcomes and patient-reported experience measures, health system utilization, and intervention usability. The primary outcome will be analyzed using an ANCOVA, with continuous secondary outcomes analyzed using Poisson regression. Direct observations will be conducted of the implementation and application-specific training sessions provided to each site. Semi-structured interviews will be conducted with participants, healthcare providers, organizational leaders, and system stakeholders as part of the embedded process evaluation. Thematic analysis will be applied to the qualitative data in order to describe the relationships between (a) key contextual factors, (b) the mechanisms by which they effect the implementation of the intervention, and (c) the impact on the outcomes of the intervention, according to the principles of Realist Evaluation.DiscussionThe use of mobile health and virtual tools is on the rise in health care, but the evidence of their effectiveness is mixed and their evaluation is often lacking key contextual data. Results from this study will provide much needed information about the clinical and cost-effectiveness of a mobile application to improve diabetes self-management. The process evaluation will provide valuable insight into the contextual factors that influence the application effectiveness, which will inform the potential for adoption and scale.Trial registrationClinicaltrials.gov NCT02813343. Registered on 24 June 2016 (retrospectively registered).Trial Sponsor: Ontario Telemedicine Network

Prototypes of User Interfaces for Mobile Applications for Patients with Diabetes

“…A questionnaire survey was carried out on a sample of 30 respondents (aged [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] to verify the functionality and user-friendliness of the proposed solution. The proposed solutions were tested on a sample of users to determine which combination of functions and which graphic designs are preferred, which services are the most important for users, and whether findings derived from the analysis of the studies and applications will be confirmed.…”

“…However, the results show that most applications do not include all four elements, and the general conclusion drawn in all the studies is that there are major limitations in the contents of the applications [13,17]. Other limitations mentioned in the studies [15,18] are the lack of personalized feedback [19,20], and insufficient support regarding the patient's behavior, with the aim of encouraging them to learn new skills and to build new habits [21][22][23][24].…”

Technology in Diabetes and Diabetic Foot Education - Mobile Education

“…Birçok çalışma gösteriyor ki, mobil uygulamalar diyabetli bireylerin öz yönetimleri, pozitif yönde davranış değişikliği, HbA1c kontrolü açısından çok avantajlıdır (44)(45)(46)(47) . Mobil sağlık teknolojilerinin ilerlemesinde mobil uygulamaların yeri büyük önem taşı-maktadır.…”

The role of text messaging intervention in Inner Mongolia among patients with type 2 diabetes mellitus: a randomized controlled trial

“…Type 2 diabetes mellitus (T2DM) and its complications can be controlled through long-term management [6,7], but most diagnosed patients cannot adhere self-management to an extended time, especially after they left hospital. Therefore, real-time health education and reminders are essential.…”