Background
Diabetes represents an important public health challenge in India and globally. It affects the quality of life and is one of the leading causes of death and disability. The burden on global health is huge, and about 463 million adults are currently living with diabetes. 77 million people in India in the age group of 20–79 years are affected by this pandemic, and the total cost of health expenditure is 8 billion US dollars. This is a huge burden and a great economic cost on public health. The research aims to explore the concept of diabetes self-management and major research questions would comprise asking what affects self-management in people with diabetes and how m-health applications and interventions can impact the self-management behaviors in development and the utility of the m-health apps in self-management of people with diabetes. Therefore, this research protocol is of great significance and would bring an integrative approach to self-care management. This study protocol was developed on the m-health application and testing nutrition informatics intervention for self-care management of type 2 diabetes at home.
Objective
To design, develop, and assess the impact of an m-health-enabled nutrition informatics intervention for home-based type 2 diabetes self-management in an Indian setting.
Methods
The study is divided into three phases, in the first phase a systematic literature review of global and Indian literature using Scoping review method using PRISMA- SCR tool to report on various m-health interventions on Self-care management regimes on type 2 diabetes and Nutrition informatics will evaluate the effectiveness and utility of m-health application developed on Selfcare management with nutrition informatics will be reported. In the second phase m-health application on Selfcare management and nutrition informatics regime will be made and in the third phase of the study evaluation of the m-health application will be done using System Usability Scale (SUS) usability and mixed research evaluation with end-users using Diabetes based management system (DBMS)questionnaire. A mixed research study will be conducted between June 2022 and March 2023. A sample of approximately 250 individuals will be recruited and enrolled using a non-probability complete enumeration sampling method from selected urban settings in Delhi. The inclusion and exclusion criteria for males and females aged 20–79 years old with Type 2 diabetes and access to a smartphone. Data will be collected using globally tested tools like the Diabetes Based Management System (DBMS) questionnaires. The collected data will be used to assess the use and utility of the mobile health application developed. The qualitative study using IDIs and FGD will be done to understand knowledge, attitudes, practices, and beliefs regarding diabetes self-care management. Qualitative methods will be focus group discussion (FGD) and in-depth interviews (IDIs) in the study. Lastly, the study questionnaire system usability survey, a global tested tool (SUS), will be used to assess the usability of mobile applications for self-care management of diabetes. Therefore, this study involves three phases, phase 1 will be scoping review using the PRISMA reporting, phase 2 is a human-centered design (HCD) of m-health informatics application for type 2 diabetes and phase 3 will be the evaluation of the designed application using globally tested tool System usability scale (SUS).
Results
A sample of 250 individuals will go through a pretested DBMS questionnaire. The data collection will be initiated in June 2022, and the initial results are planned for publication by July 2023. Out of n = 250 individuals, at least 120 individuals will be retained in the study. A qualitative study using descriptive analysis of the gathered data will be performed using SPSS V11, and reporting of the results will be done at 95% CIs and P = .0.05. A qualitative study will be exploratory sequential and the first exploratory study using IDIs and FGDs will be done followed by a quantitative method this exploratory sequential study will draw inference from the mixed study.
Conclusions
The findings of the study using scoping review would inform the elements essential for the development of m-health to improve self-care management of diabetes at home settings in India and its wider application in the global framework. The m-health application will be designed on m-health nutrition informatics. The usefulness and acceptance of the proposed m-health intervention will be evaluated using the globally tested tool System Usability Scale (SUS) for evaluation.