A stepped wedge cluster randomized trial to evaluate the effectiveness of a community leader-driven kit-based diabetes self-management education approach in improving diabetes control and care: study protocol for the DElhi Diabetes INTervention Trial (DEDINTT)

INTRODUCTION: Diabetes self-management education (DSME) helps patients self-manage their condition and improve outcomes/quality of life. However, access to DSME is limited, particularly in low-income areas. This study aims to develop a DSME training kit (EK-DIN), understand barriers to implementation, and evaluate the effectiveness and sustainability of community leader (CL)-based rollout using a stepped wedge cluster randomized trial format. METHODS AND ANALYSIS: The mixed methods study will begin with a qualitative study to evaluate the facilitators and barriers towards CL-based DSME. The in-depth interview notes will be transcribed for thematic analysis. These results will be utilized for a stakeholder’s workshop to develop the EK-DIN kit, a patient-interfacing app, and an implementation plan. Rollout will be conducted in 30 clusters in Delhi, preselected by the DEDICOM-II survey in 5 steps (6 clusters every 3 months: 2 each from each socio-economic category; randomly selected per sequence). A CL from each cluster will be trained in using the EK-DIN kit/app over 1 month. The trained CL will conduct DSME sessions among the cluster residents using the EK-DIN kits provided fortnightly for 3 months. Compliance and blood parameters data will be collected at baseline, 3 months after the intervention, and every quarter thereafter till completion. Change in HbA1c before and after the intervention will be evaluated as the primary outcome using the swCRTdesign package for R version 4.0.2 and the swSummary function. The sustainability of the effects will be evaluated using the change in quarterly parameters after intervention completion. DISCUSSION: A positive result will set the template for a generalizable public health intervention with proven community effectiveness, sustainability, cost-effectiveness, and positive quality-of-life impact. While a negative result will require the testing of alternative approaches, it would still add substantially to existing knowledge on the subject. Given the diverse socio-cultural setting in which the trial is being proposed and the high power of the study, the results (positive or negative) should be widely applicable and have policy implications. TRIAL REGISTRATION: CTRI/2023/07/054963. Date of Registration: 7th July 2023.