Development and evaluation of a culturally tailored education module for type 1 diabetes in a resource-constrained setting: protocol for a mixed-methods study

Background: Diabetes education is the key to successful diabetes management. There is a need for an education module for type 1 diabetes (T1D) that is culture-specific and suited to resource constraints. Methods: A mixed-methods study will be conducted, in three phases, to develop and evaluate a culturally tailored diabetes education module for Indian children with T1D and their families. During the first phase, a qualitative study among health professionals and families of children with T1D for need assessment will be conducted. During the second phase, based on the themes from the last phase, an educational module will be developed. The third phase will involve an evaluation of the content, feasibility and effectiveness of the proposed module. The content evaluation will be done using the standardized 'suitability assessment of materials' checklist. For feasibility, a mixed-method approach will be used with iterative cycles of satisfaction scale, semi-structured interview and feasibility and observation checklist. The module will be revised after each cycle till no new changes are suggested. The effectiveness will be assessed by a quasi-experimental controlled trial assessing glycemic control, health-related quality of life, clinically important events and self-management practices in T1D children at baseline and three and six months. Conclusions: This study aims at development and validation of a novel culturally tailored diabetes education module for children with T1D, suited to their resource constraints. A module designed with the inputs from all stakeholders, and evaluated using iterative cycles, has the potential to suit the dynamic nature of diabetes management in children. Trial registration: Trial registration number is CTRI/2021/04/032739.